Amgen is recalling 934,577 bottles of heart failure drug Corlanor (ivabradine) 5 mg strength tablets due to the presence of an unspecified “foreign substance” in the tablets. Corlanor was recently discontinued by Amgen, although generics will still be available. This recall also affects an unspecified number of 7.5 mg strength bottles (60-count). The pills were made in Italy; 29 lots with expiration dates are between 8/31/2026 and 3/31/2027 are affected.

As part of this same recall event, 9,565 bottles of Sensipar (cinacalcet) 30 mg (expire 12/31/2027) plus unspecified quantities of 60 mg (Date 1/31/2028) and 90 mg (02/29/2028) tablets are under recall by Amgen due to CGMP (manufacturing quality) deviations. Sensipar has also been discontinued by Amgen, but generic versions are available. Cinacalcet treats hyperparathyroidism, a condition in which one or more of the parathyroid glands in the neck produce too much parathyroid hormone (PTH). The parathyroid glands help regulate calcium absorption, use and removal by the body.
Read more about hyperparathyroidism at Medline Plus.
Read Patient reviews of Sensipar at the AskaPatient website

Both Amgen recalls are listed in this FDA Enforcement Report (scroll down the linked page to see specific product information including lot numbers and expiration dates).

Recall of Chlorthalidone by Inventia Healthcare

Inventia Healthcare is recalling 11,460 bottles of 25 mg chlorthalidone tablets due to “failed dissolution specifications.” Chlorthalidone treats high blood pressure and is a “water pill” (diuretic) type of treatment. This product, in 100-count and 1000-count bottles, was labeled and distributed by Rising Pharma. Check the FDA Enforcement Report for lot numbers and expiration dates.

Recall of Birth Control Pill Alyacen by Glenmark

An unspecified quantity of Glenmark’s Alyacen 7/7/7 oral contraceptive blister card packs containing norethindrone and ethinyl estradiol tablets are being recalled due to a quality problem described as “out-of-specification results for total impurities.” The product was manufactured at Glenmark’s Goa, India location. Each card contains 28 tablets. Includes lot #: 20240411 with expiration of 6/30/2026 and lot # 20250252 with expiration 3/31/2027. FDA Enforcement Report

Recall of Generic Abilify (Aripiprazole) by Ajanta

Ajanta is recalling 6,143 bottles of 30 mg strength schizophrenia treatment aripiprazole (generic for Abilify) because the bottles may contain voriconazole tablets, an antifungal treatment. Aripiprazole is also approved to treat Tourette’s disorder and irritability associated with Autistic disorder.
Check the FDA Enforcement Report for expiration dates and lot numbers.
Read patient reviews of Abilify (aripiprazole) at Ask a Patient

Recalls for Antifungal Creams, First Aid Ointments, Hydrocortisone Creams

Dabur India Limited is recalling almost 30,000 tubes of over-the-counter topical medications under various brand and private label names because of serious manufacturing deficiencies and violations found during an FDA inspection of its Dadra and Nager Haveli, India facility. The products distributed through consumer retail channels include Lucky Super Soft Antifungal Athlete’s Foot Cream, Lucky Super Soft, First Aid Triple Antibiotic Ointment, Circle K, triple antibiotic ointment (L’il Drugstore brand), Cura Hongos, Crema Antifungica, and Rapidol, Triple Antibiotic First Aid Ointment. The consumer products were made for Delta Brands, L’il Drugstore Products, and Pharmadel LLC.

Dabur India’s products branded as Med Pride (a Shield Line wound products brand) and distributed to hospitals and other medical facilities are also under recall and include Bacitracin Zinc Ointment, Med Pride Hydrocortisone Cream, Med Pride Triple Antibiotic Ointment.

During its inspection of the manufacturing facility in January, FDA discovered multiple violations of CGMP (Current Good Manufacturing Practice). These included records falsification, inadequate laboratory controls, inadequate microbiological testing, facility maintenance, and cleaning violations. On June 5, the FDA added Dabur’s Dadra and Nager Haveli facility to its Import Alert List, banning all drug and vitamin products from that manufacturer from entering the U.S.

Check the FDA Recall Enforcement Report for a complete recall list with product expiration dates and lot numbers

The Hans India: “US FDA flags manufacturing and data integrity lapses at Dabur India plant”
Qvents: “Dabur Facility Placed Under Import Alert”

Recall of Methylergonovine Maleate by Harvard Drug Group

Harvard Drug Group is recalling 20 cartons (about 16,000 blister packs) of methylergonovine maleate tablets (2mg) because the tablets are subpotent (contain less than the labeled amount of active ingredient). Methylergonovine maleate is used after childbirth or during the last stage of childbirth to prevent or stop uterine bleeding. The three recalled lots have expiration dates of September 2026, December 2026, and August 2027. The tablets were made by Granules Pharmaceuticals in Chantilly Virginia and packaged and distributed by Major Pharmaceuticals. Check the FDA Enforcement Report for lot numbers.
Read patient reviews for methergine at AskaPatient

Farxiga Generics Growth; New Safety Warning

Astra Zeneca’s blockbuster (more than $6 billion in sales in 2023) type 2 diabetes/heart failure/kidney disease drug Farxiga (dapagliflozin) was approved in 2014. Dapagliflozin works by helping remove sugar from the kidneys and preventing reabsorption. In less than three months since the FDA’s April announcement of the first generics approvals, more than 15 generic versions have been approved and eight more have received tentative approval. An “authorized” generic (identical to the brand name) is available from Prasco, who partnered with Astra Zeneca after Medicare named Farxiga one of its first 10 drugs for price negotiations.

FDA Press Release: FDA-approves-first-generic-dapagliflozin-tablets

A recent safety update for dapagliflozin clarifies and strengthens warnings about Genitourinary Infections, which encompass urinary tract infections and genitals-related infections. Dapagliflozin-associated infections include Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections.

Read Patient Reviews of Farxiga at Ask a Patient website.

Study Shows Oseltamivir (Tamiflu) Linked to More Deaths in Hospital

Oseltamivir (Tamiflu brand name) has been a standard treatment for influenza for more than 20 years. Findings from a large global ongoing trial may change the guidelines, at least for severely ill patients in the hospital. Until the guidelines actually change, if you or a family member is hospitalized with influenza, you may want to question or intervene with a provider’s decision to administer oseltamivir.

In the REMAP-CAP trial (explained below), adult patients with severe flu who needed to be admitted to Intensive Care Units (ICU) were randomly put into groups who were either given oseltamivir, or not given oseltamivir. All other parts of treatment were decided by the team caring for them. Many of the patients were receiving non-invasive oxygen support or invasive mechanical ventilation. The press release highlights the findings:

“Unexpectedly, we found that for these patients, NOT giving oseltamivir was linked with better outcomes (fewer deaths). These results suggest that patients with severe flu who need to be admitted to an ICU should not receive oseltamivir, even though it is currently part of standard care.

This was very surprising because there had been some studies suggesting that oseltamivir is safe, and may have a small benefit to patients. But almost all of these studies were for people who were not in hospital or an ICU.”

Alasdair Munro, medical doctor and writer of The Munro Report, explains why this study is a game-changer and why earlier studies on oseltamivir are problematic. He also shares the surprising findings of the “SNAP” clinical trial involving 3,800 patients with Staphylococcus aureus infection. Patients received either a primary antibiotic alone for five days or clindamycin given alongside the primary antibiotic. The clindamycin group experienced higher rate of deaths. Check out “When doing more harms patients.”

The Munro Report

When doing more harms patients

Two trials reported in the last few weeks, in two completely different infections, point at the same uncomfortable idea. Some of the things we do for our sickest patients, that the guidelines tell us to do, and the observational evidence seemed to support, may have been harming, or even killing them…

Read more

22 days ago · 57 likes · 28 comments · Alasdair Munro

More about the REMAP-CAP Trial:

The Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) was conceived after the 2009 Influenza AH1N1 (”Swine flu”) outbreak, and was initiated in Europe in 2014. The trial is embedded within a network of over 300 participating research centers in eight global regions and continues to grow.

Hospitalized patients with respiratory tract infection (Community Acquired Pneumonia, Influenza, or COVID-19) are usually treated with a combination of treatments rather than a single drug. The Adaptive Platform Trial embedded in clinical care allows multiple therapies to be evaluated at the same time under a master protocol. Read more About REMAP-CAP.

Generic Available for Xofluza: Baloxavir Marboxil for Influenza

FDA approved Norwich Pharmaceuticals’ baloxavir marboxil tablets, the first generic version of Genentech’s Xofluza, which was originally approved in 2018. Baloxavir marboxil is a one-dose antiviral for age 5 and up to treat influenza within the first 48 hours of symptom onset or as a post-exposure prophylactic (preventive drug) for people who have been exposed to the flu. Not only has baloxavir been shown to be faster acting than Tamiflu, the one-dose regimen offers another advantage, since oseltamivir (Tamiflu) has a ten-dose regimen over five days.
FDA Press Release FDA approves-first-single-dose-generic-treatment-influenza

Given the poor outcomes for hospitalized patients taking oseltamivir, could baloxavir be a new treatment option in the hospital? Currently, the treatment is rarely offered in hospitals, and the CDC specifically does not recommend baloxavir for treatment of flu in hospitalized patients due to limited data. CDC also does not recommend its use for pregnant or breastfeeding women, or for severely immunosuppressed individuals.

Medication Tips: Low Calcium Concerns and Question About HRT Over Age 65

Dr. Lucy McBride, writer of Are You Okay? recently answered a question from a reader with a concern about her lab reports showing she is low in calcium, despite taking daily 500 mg calcium supplement and eating calcium rich foods. The reader learned that these foods “bind” to calcium, getting in the way of absorption. Dr. McBride explains why a low calcium level on blood work usually isn’t a story about dietary calcium intake.
Question about Dietary Calcium and Oxalate

Dr. McBride also responds to a question from a 72-year old reader who is concerned because her primary care clinic won’t prescribe Hormone Replacement Therapy, (HRT), including vaginal estrogen, to women over 65 or more than 10 years past menopause.
Vaginal Estrogen After Age 65

Did you miss the last edition? Check it out here:

Haleon, a consumer health brands company that makes over-the-counter medications for digestive health, has announced two recalls for Gas-x SoftGels (Simethicone).

The first recall involves 35,883 boxes (72-count and 120-count) of 125 mg Extra Strength Gas-x due to potential contamination with diluted propylene glycol-based coolant leaking into the product during the packaging process. Ingestion of the contaminated products may cause nausea, vomiting, abdominal pain and diarrhea. The FDA issued a FDA Press Release and an Enforcement Report. Check the press release for specific lot numbers. The product image in the press release indicates the medication was made in India.

The second, less serious recall involves 285,330 blister cards (120-count) of 125 mg strength Gas-X because the carton does not display all of the inactive ingredient information on its label. FDA Enforcement Report

Recall of Amlodipine and Olmesartan Medoxomil tablets by Ascend

Ascend Laboratories is recalling 15,696 bottles of the blood pressure drug amlodipine and olmesartan medoxomil (5 mg/40 mg) because the medication may not dissolve properly. In addition, the amount of active ingredient olmesartan medoxomil was found to be less than the required amount. This generic medication (Azor brand name) was made in India by Alkem Laboratories Ltd. Check this FDA Enforcement Report for expiration dates and lot numbers.

Recall of Duloxetine delayed-release capsules by Breckenridge

Breckenridge Pharmaceutical has a new recall for duloxetine delayed-release capsules (generic for the antidepressant Cymbalta), involving twice as many bottles as the recall announced last month. In the latest announcement, more than 359,000 bottles 60 mg strength tablets and 14,729 bottles of 30 mg strength tablets are being recalled due to nitrosamine impurities in the medication. The capsules were manufactured in Martorelles (Barcelona), Spain by Towa Pharmaceutical Europe S.L. This is Breckenridge’s fourteenth recall event for duloxetine due to nitrosamine impurities since 2024. Check this FDA Enforcement Report for expiration dates and lot numbers.

Recall of Epinephrine by Fresenius Kabi

Fresenius Kabi USA, LLC is recalling almost 900,000 single dose vials of the epinephrine injection due to quality failures for long-term stability testing. Epinephrine injections are used for emergency treatment of allergic reactions. Check the FDA Enforcement Report for expiration dates and lot numbers.

Recall of Liraglutide by Lupin

Lupin Pharmaceuticals is recalling 217,621 liraglutide pen injectors (6 mg/mL) in 2-Pen and 3-Pen packs because of the presence of white thread-like particulate matter in the cartridge. Liraglutide is a bioequivalent (generic) medication for GLP-1 diabetes treatment Victoza. This medication was made in Nagpur, India by Lupin. Check the Enforcement Report for lot numbers and expiration dates.

Moringa Capsules Dietary Supplement Recall

Total Nutrition Inc expanded its recall to 9 lots of its moringa dietary supplements TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules and Doctor’s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg. These products have been linked to more than 100 cases of salmonella nationwide. The supplements were sold on many online retailers and also on Total Nutrition’s website. The FDA and CDC have launched an investigation into the moringa-linked outbreak. Other brands have also been recalled. Check the FDA Press release for more information and product photos.
FDA Press Release (June 11) : Total Nutrition Inc. Expands Recall of TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules Because of Possible Health Risk Following Further Supply Chain Review
From May 31 newsletter: Supplements-causing-nationwide-salmonella-outbreak-moringa-leaf-capsules-recalled

How Unsafe Ingredients Can Sneak Past FDA into our Food and Supplements

In June 2022, 393 people were sickened, and 133 were hospitalized, some with permanent organ damage, after eating a Daily Harvest brand lentil food product. Daily Harvest was using a food additive that was being marketed as a new superfood with a high protein ingredient called tara flour. The flour was never tested for safety. In this interview, Planet Money talks with a victim of the food poisoning (who had to have her gallbladder removed) and a lawyer at the Environmental Working Group who explains how companies can “sneak new chemicals past the FDA and into our food and supplements.” This radio interview is 3 minutes long; transcript is available:
How Companies Can Sneak New Chemicals Past the FDA and Into Our Food and Supplements

In April 2026, New York legislature passed a law that will require the food industry to disclose details about their use of “Generally Recognized as Safe” (GRAS) ingredients. It is awaiting the governor’s signature.
Food Safety Magazine: New-york-poised-to-ban-certain-food-additives-require-gras-ingredient-transparency

FDA Approves First New Sunscreen Ingredient in 20 Years

In December 2025, we reported that FDA was reviewing a new sunscreen ingredient called bemotrizinol. Last week, bemotrizinol was approved, with the FDA finding that it provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. The ingredient has been used in sunscreen products in other countries for decades. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older. Until this approval, only Zinc and titanium dioxide had GRASE designation for use in sunscreens. (Check our previous article that explains why Avobenzone, Oxybenzone, and Octocrylene are still in sunscreens but are not considered GRASE.)

DSM Nutritional Products was granted exclusive rights for use of the ingredient for 18 months. Bemotrizinol is the first new active ingredient added as an authorized the over-the-counter (OTC) ingredient since the late 1990s. It will sell bemotrizinol to sunscreen makers under the brand name Parasol Shield and be available at concentrations up to 6% in over-the-counter sunscreen products. According to the People’s Pharmacy, the new products most likely won’t be available for sale in stores until Fall 2026 or even Spring 2027.
FDA Press Release: FDA-expands-sunscreen-options-first-time-in-20-years
The People’s Pharmacy: Safe Sunscreen at Last? FDA Approves First New UV Filter in 25 Years! Discover what it means for choosing a safe sunscreen. When can you buy it? (This article also reviews the safest sunscreen products to consider until the new product becomes available.)

New Warning for Migraine Treatments

A category of migraine headache medications carry a new warning about the risk of serious constipation that can result in hospitalization or surgery. The new warning applies to CGRP (calcitonin gene-related peptide) inhibitors and so far includes Ajovy, and Emgality, which are monoclonal antibody (“large molecule”) types.

The side effect was flagged for further FDA review in 2025 and the warning was added this month. If you are taking one of the CGRP drugs and experience severe constipation or symptoms such as severe or constant belly pain, vomiting, swelling of belly, or bloating, contact your doctor. Other migraine drugs flagged in 2025 but so far not receiving the new warning include Aimovig (also a monoclonal antibody), Nurtec ODT, Ubrelvy, and Zavspret.
Ask a Patient: “New Warnings for CGRP Migraine Headache Drugs: High Blood Pressure, Raynaud’s, Constipation”

Illegal Prescriptions Abound for Unapproved GLP-1 Retatrutide

More than 120 web sites and over 50 in-person clinics are marketing Retatrutide, an Eli Lilly GLP-1 experimental medication which has not yet been submitted for approval consideration by the FDA. The clinics are staffed by licensed physicians and nurse practitioners who claim that the clinical evidence is strong enough to bypass the standard regulatory timeline. In trials, retatrutide shows larger weight loss results than other GLP-1 drugs on the market. An FDA database check reveals that at least 16 warning letters have been sent to telehealth, online pharmacies, and compounding pharmacies for selling or promoting illegal retatrutide.
CBS News Investigation: Experimental Weight Loss Drug Doctors are Prescribing

Over-the-Counter Continuous Glucose Monitor (CGM) Approved for Kids Age 2 and Up

The FDA expanded approval of Dexcom Inc.’s Stelo Glucose Biosensor System, an over-the-counter (OTC) continuous glucose monitor (CGM), for use by children age 2 and up who do not use insulin. This would exclude Type 1 diabetes patients and Type 2 diabetes patients using insulin.

Stelo was approved for over-the-counter use by adults in 2024. A sensor worn on the skin pairs with an application on a compatible smartphone or other smart device, including a parent’s or caregiver’s phone, to continuously measure, record, and display glucose values every 15 minutes. There was no trial specific to children’s use of the device. Instead, “FDA drew on prior clinical study data from pediatric and adult populations, combined with real-world data on current iCGM use, to model expected device performance in children across the full 15-day wear period.”

Stelo is not intended for people with problematic low blood sugar (hypoglycemia), because the system is not designed to provide low blood sugar alerts. The device costs about $100 a month, and is not typically covered by insurance.
FDA Press Release: FDA-Clears-First-Over-Counter-Continuous-Glucose-Monitor-Children

Increasingly, adults are using CGMs for general wellness reasons, not because they are pre-diabetic or have diabetes. It is unclear why parents would monitor young children with this device, since children with Type-1 diabetes would be using insulin and ineligible and are unlikely to have Type-2. Adolescents using Wegovy or liraglutide for type 2 or obesity might be candidates, but they likely would use a CGM covered by insurance. Some teens however, might use it to monitor for prediabetes.

Here are three perspectives and testimonials about continuous glucose monitoring for wellness reasons:

Dr. Luis Gonzalez: Glucose Spikes or Business Spikes?
How Carb Phobia Fuels a Multi-Billion-Dollar Market
“What began as a legitimate warning about the risks of glucose spikes in metabolically vulnerable populations has, in the hands of certain influencers and companies, become an alarmist message directed at the general healthy population.” Dr. Gonzalez outlines documented risks, including the potential for constant monitoring that can “create added stress and fixation on normal blood glucose fluctuations.”

Jeff Krasno: Is This Right For Me? Continuous Glucose Monitors (CGM)
What Your Blood Sugar Is Actually Telling You
Krasno, owner of a masterclass platform for well-being, says that his experience using a CGM led him to understand that “your CGM is actually a stress monitor. Not by design. By accident. But it may be the most honest stress monitor you’ve ever worn.” He cautions that it is easy to become obsessed with checking your numbers. If you have a history of disordered eating or significant health anxiety, he recommends talking to a provider first. Also, he notes a study that showed that people respond dramatically differently to the same foods. One person’s healthy lunch is another person’s glucose spike.

Jeff’s Substack

Is This Right For Me? Continuous Glucose Monitors (CGM)

In 2018, I exited Wanderlust, the yoga festival business that I co-founded 10 years earlier. It was a wonderful and harrowing decade running the Lollapalooza of wellness…

Read more

2 months ago · 21 likes · 4 comments · Jeff Krasno

Victoria Lee: “I Wore a Glucose Sensor 24/7 for 28 Days: A Physician’s 4-Week CGM Experiment”

Victoria Lee, a physician and wellness leader “on a mission to bridge ancient wisdom and modern science” and writer of Seoul to Soul used Abbot’s FreeStyle Libre 2 for four weeks and shares her experience. She also provides a table comparing key details about five CGM products (including the Dexcom’s Stelo).

Earlier this year: In February there was a recall of 3 million Abbot continuous glucose monitor sensors after malfunctions led to 860 injuries and 7 deaths because of falsely low glucose readings.
Ask a Patient Health News: Abbott-recalls-continuous-glucose-monitor-sensors-for-freestyle-libre-3-and-libre-3-plus-system

Medical Device Tips: Over-the-Counter Hearing Aids Recommendations

New York Times’ Wirecutter’s Over the Counter Hearing Aids and Other Hearing Solutions provides detailed reviews of its top three picks for over-the-counter hearing aids.

Wirecutter’s spreadsheet provides information for 22 of its previously-tested hearing aids and PSAPs (personal sound amplification products) that are still available, including Apple’s ear buds that function as hearing aids.
Wirecutter Competition Notes: Over the Counter Hearing Aids

Medication Tips: The Type of Water (or Beverage) You Drink Matters When Swallowing Your Pills

Researchers at Semmelweis University (Budapest, Hungary) studied how different liquids could affect enteric-coated medications. Tablets that are enteric-coated are designed so that the active ingredient is not released in the stomach (which is acidic) but later in the intestines (which is alkaline). Enteric coatings are commonly used on certain reflux medications, anti-inflammatory pain relievers, and digestive enzyme products.

The study analyzed 22 commonly consumed beverages, including detailed lab analysis of mineral and medicinal waters, tap water, filtered water, and apple juice. Alkaline bottled waters with high mineral content triggered premature drug release. By contrast, more acidic liquids, like apple juice, caused less damage to the enteric coating of the medications.

“Healthcare professionals generally assume that medications are swallowed with plain tap water, but that is not always obvious to patients today, given the wide variety of mineral and medicinal waters available on the market.” The study was published in Pharmaceutics. 2026;18(4).
Semmelweis University Press Release: “It Matters What Liquid You Take Your Medications With”

Did you miss the last edition? Read it here:

Total Nutrition Inc. is recalling TNVitamins Ultra Potent Complete Green Superfood capsules and Doctor’s Pride Complete Green Superfood Ultra Potent Moringa Capsules (120 count) because the products may be contaminated with Salmonella, an organism which can cause serious illness or even fatal infections in the elderly, young children, or those with compromised immune systems. The recalled products were distributed nationwide through the online platforms, Amazon, Walmart, TikTok Shop, Target, and the company’s websites.

People infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Symptoms usually start 6 hours to 6 days after infection and usually last 4 to 7 days. So far, 119 people have become sick with salmonella poisoning and the CDC and FDA are investigating whether additional products are involved. This is the second moringa leaf-related salmonella outbreak so far this year.

FDA Press Release: FDA Recall of Total Nutrition Supplements / Morginga "Complete Green Superfood" Capsules

Summary of case counts (from CDC):
Total Illnesses: 119 (22 new)
Hospitalizations: 32 (6 new)
Deaths: 0
Last Illness Onset: April 26, 2026
States with Cases: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, KY, MA, ME, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI

• Related Recalls: Superfoods, Inc. Recall, Why Not Natural Recall

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Recall of Erythromycin by Zydus

Zydus Pharmaceuticals is recalling almost 35,000 bottles (30 and 100-count) of 250 mg and 500 mg of antibiotic erythromycin tablets due to presence of nitrosamine above the allowed limits. The tablets were manufactured by Zydus Lifesciences Ltd. In Ahmedabad, India. Nitrosamine in medications may increase the risk of cancer. The recall is directed at suppliers, but consumers may check the enforcement report for lot numbers or check with their pharmacy to find out if their medication was affected by the recall. The tablets expire in August 2026 or January 2027.
FDA Enforcement Report

Rugby Nicotine Patches by Avea

Aveva Drug Delivery Systems is recalling 59,808 Rugby Nicotine Transdermal System Patches (4,272 individual 14-count cartons), 14 mg, Aveva due to elevated levels of oxidative impurities, which could affect the product’s shelf life. Lot #: 56841, Expires: 03/2028. The 14 mg strength is the “step 2” of the 3 part quit-smoking system. The product was distributed by Rugby Laboratories (now known as Major-Rugby) in Indianapolis.
FDA Enforcement Report

Tums Ultra Assorted Fruit Chewable Recall

CVS is recalling two lots of Tums Ultra Assorted Fruit Chewable Tablet 1000 mg in 160-count bottles. Lot numbers are 1096078 and 1096078 with expiration dates of 31 JAN 2029 due to potential contamination with small metal pieces. Customers who purchased recalled product should stop using it and may obtain full refund by returning product to CVS. This recall has so far not been posted on the FDA website. Check link for product image.
CVS Tums Recall

New Approval: Inhaled Insulin for Children with Diabetes

The FDA expanded the approval for Mannkind’s Afrezza (insulin inhalation powder), for children age 6 and older with diabetes (Type 1 or Type 2). It is the first needle-free insulin treatment option available for children. CBS News Philadelphia interviewed fifteen-year-old Greg Stanoch from Chadds Ford Pennsylvania, who was diagnosed with Type 1 diabetes in first grade. Greg participated in the clinical trial and used Afrezza for four years before it was approved for kids. Afrezza has a boxed warning about the risk of bronchospasms in people with asthma, COPD, lung disease. It should also not be used by those who smoke or recently quit smoking. The inhaler is used at the beginning of each meal. It was originally approved in 2014.

CBS News Philadelphia: “FDA Approves Needle-Free Insulin for Children”
Company press release: Mannkind Corp Press Release

Have an experience (good or bad) with AFREZZA? Rate AFREZZA at Ask a Patient.

GLP-1 News: Medicare to Cover GLP-1 for Weight Loss for $50 copay

According to a poll conducted by KFF, one in eight American adults is currently taking a GLP-1 medication. Many Medicare beneficiaries have not had access to them as a weight loss drug because of Medicare Part D exclusions of coverage for weight loss. Starting in July 2026, Medicare is launching the GLP-1 Bridge Program, which will, for the first time, allow beneficiaries to access GLP-1 medications prescribed specifically for weight loss in a pilot program that will run from July 1, 2026 through December 31, 2027. The program covers all formulations of Wegovy and Foundayo, plus the KwikPen formulation of Zepbound at a flat $50 copay.
Checkbook.org: Medicare and the New GLP Bridge Program: What Beneficiaries Need to Know Before it Launches this Summer

GLP-1 Drugs and Cancer Progression

A poster presentation will be presented at this week’s American Society of Clinical Oncology (ASCO) annual meeting. Researchers from Cleveland Clinic looked at patient data sourced from the TriNetX Global Health Research Network for over 10,000 patients with seven different types of solid tumors. The research found that patients with breast, liver, colorectal and lung tumors who began taking GLP-1 receptor agonist drugs after their cancer diagnosis had a lower risk of their cancer progressing, compared with patients taking a different type of medication used to treat diabetes called DPP-4 inhibitors or gliptins. Examples of gliptins include itagliptin (Januvia) Linagliptin (Tradjenta) Saxagliptin (Onglyza).

However, the other three types of tumors: prostate, pancreatic, and kidney did not have statistically significant lower risk of cancer progression. The press release contains the risk level reductions, which were as much as 50% for some cancer types.

ASCO Press Release: GLP-1s May Reduce Metastatic Progression of Certain Obesity-Related Cancers
Research Abstract

Auvelity: New Side Effects

Axsome Therapeutic’s Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets recently received expanded approval to treat agitation associated with dementia due to Alzheimer’s disease. A newly discovered side effect for Auvelity that is more likely to happen in the elderly is hyponatremia, or low levels of salt in the blood. Symptoms of hyponatremia include headache, difficulty concentrating, memory changes, confusion, weakness and unsteadiness on your feet. Severe cases may include hallucinations, fainting, seizures and coma. If not treated, severe low sodium levels can cause death. Postmarketing reports of feeling abnormal, tinnitus, and tremor were also added in this label update. Auvelity was originally approved in 2022 to treat major depression in adults.
Safety-Related Label Change for Auvelity.

Ramipril and Severe Delayed Hypersensitivity Reaction

The ACE inhibitor-type blood pressure drug Ramipril (formerly Altace brand name, which has been discontinued) has an updated warning about the potentially life-threatening risk of angioedema. Angioedema is a sudden swelling in the tissue beneath the skin, most commonly affecting areas like the lips, eyelids, and throat. Ramipril’s label now states that angioedema can happen at any time, even months or years after starting treatment. The onset of ACE inhibitor-induced angioedema is more likely to happen after the first dose or in the first weeks of treatment. Patients with symptoms of angioedema should discontinue the medication immediately and consult a healthcare provider. Ramipril was approved in 1991 as the Altace brand and is available as a generic capsule medication.
Altace (ramipril) Safety Labeling Change

Read more about angiotensin converting enzyme (ACE) inhibitor-induced angioedema at Dermnetz

Rx-OTC Switch Poll Results

The FDA is considering making it easier to switch drugs from prescription-only to over-the-counter status. In an informal poll on our website, we asked readers whether they agreed with the move, and more than 80% did. Drugs suggested as good candidates to move over-the-counter include albuterol for asthma, antivirals, statins, Epi-Pen for allergic reactions, and rosuvastatin for high cholesterol.
Ask a Patient News: Converting More Rx to OTC

Generic Drug Quality and Safety

Contaminated products and failed facility inspections leading to recalls and production halts have put a spotlight on generic drug safety. Concern about generic drugs not working the way they should is also a problem: a recent survey by MedShadow Foundation/Kantar found that one in three Americans say their generics don’t always work the same.

On the Ask a Patient site, some patients complain about generic formulations changing or that they have to insist on receiving (and paying a much higher price) for a brand name version because the generics don’t work the same. Could it be that the generics are just too cheaply produced, making it impossible to get a quality pill for the amount being spent on production? The MedShadow/Kantar survey revealed that many Americans would pay more, sometimes a lot more, for a better quality generic drug. Would you? Here’s our quick, informal poll on the topic (click the caption below to answer the poll):

Specific generic drugs flagged by readers at Ask a Patient as not working as expected include: Ritalin (Methylphenidate), Norco (Amneal version of acetaminophen/hydrocodone), Vivelle dot generic (contraceptive patch), Microgestin (oral contraceptive problems with Mylan version), Aciphex (Proton pump inhibitor used for GERD or ulcers – problem with Mylan version of rabeprazole), and others.

Proposals to Improve Generic Drug Quality

In a recent New England Journal of Medicine paper, two health experts caution that although the U.S. has saved trillions on generic drug costs since 1984 (when the current generic drug approval process was established), the FDA cannot fully guarantee the safety of generic drugs. They suggest five reforms that could strengthen regulation and improve the integrity of the generic drug supply chain.
MedShadow Foundation: “Experts Warn of Generic Drug Safety Risks”

Treatment Tips: Beware of Mental Health Apps: Recommended Podcast

Linda Michaels, psychologist and co-founder of the Psychotherapy Action Network, was a recent guest on the entertaining and insightful Organized Money podcast that examines how corporate consolidation and monopolies are affecting every aspect of the economy. Hosts Dave Dayen and Matt Stoller interviewed Michaels about the behind-the-scenes business of mental telehealth services like TalkSpace and BetterHelp. They learned how big tech (including Google) has become a major exploiter of both the therapist and the patient.

Michaels wants people to realize that when you use a chat-based therapy app, or video therapy session through one of these services, what you say is often recorded, transcribed, and shared. Your private conversation with your therapist may even be used for training the service’s own “proprietary” A.I. models. Because the therapist, as an independent contractor, does not “own” the psychotherapy sessions (the tech company does), he/she has little power to control what happens to them. The convenience of a zoom therapy session managed by a “practice management company” like Headway comes packaged with risks that do not exist in traditional therapy. Some progress has been made in states like Illinois, where limits have been imposed on mental health apps.
This podcast is 58 minutes long. You can also find the episode on KUOR , NPR’s Seattle radio station.

Organized Money

The Chatbot Will See You Now: Tech In Therapy

Welcome to the podcast Organized Money. You can listen to today’s episode on Apple on Spotify, or wherever you get your podcasts…

Read more

2 months ago · 20 likes · 1 comment · David Dayen and Matt Stoller

Related: Proof.org, investigates the social impacts of AI: “Woman’s Talkspace Therapy App Sessions Exposed in Court”
An investigation by Proof News found that therapy sessions on the telehealth platform Talkspace are at risk of exposure and subject to exposure in court. They note that “Talkspace has amassed ‘one of the largest mental health data banks in the world,’ according to reports to investors, containing 140 million message exchanges.”

Medication Tips: Healthy Kidneys

Dr. Lucy McBride, writer of Are You Okay? answers a question from a 64-year old reader who had painful kidney stones two years ago and now wants to make sure her kidneys stay healthy. What can she do in the long term to protect them?
Question and Answer on Kidney Health

Did you miss the last edition? Check it out here:

Pharmacal is recalling an over-the-counter skin cream, MG217 Multi-symptom Treatment Cream & Skin Protectant (Colloidal Oatmeal), due to contamination with the bacteria Staphylococcus aureus. Using the product could cause severe or life-threatening reactions. The recalled topical cream treats skin irritation, dryness, and redness, and comes in a 6 ounce tube with product code 5106 and UPC 012277051067. It was distributed nationwide to wholesale, retail (HE BUTT Grocery), and internet distributors (Amazon). Pharmacal says it has not received any reports of adverse events related to this recall. FDA Press Release:
”Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination”

Duloxetine Delayed Release Capsules Recall by Breckenridge, Ajanta

Breckenridge Pharmaceutical is recalling 165,761 bottles of 60 mg capsules (90-count), due to the presence of nitrosamine impurities above the FDA-recommended limit. These capsules were made by Towa Pharma in Barcelona, Spain and distributed nationwide. Duloxetine is an antidepressant, generic for Cymbalta. The only lot number affected is 241069C with an expiration in May 2027.
FDA Enforcement Report
Read more about Nitrosamine Impurities (FDA information page)
Have you taken duloxetine (Cymbalta)? Read or add your reviews at Ask a Patient website, and if you used a generic, note that in the comments.

Ajanta is recalling more than 500,000 packs of 20, 30, and 60 mg capsules of Duloxetine delayed-release capsules, made in India, due to the presence of nitrosamine impurities (a cancer causing ingredient) above the FDA-recommended limit. The impurities were detected at long-term stability testing done at 12 or 18 months. The recalled capsules expire soon; in May or June 2026. Check the link for lot numbers.
FDA Enforcement Report (Ajanta/JB recall)

Eye Drops Recalls by Oasis and FreshKote

Oasis Medical is recalling an unspecified quantity of Oasis Tears PF, Preservative-Free Lubricant Eye Drops out of an abundance of caution after quality deficiencies were identified during a routine FDA inspection of the manufacturer Excelvision. The product is in a 10mL/0.34 Fl Oz bottle, and is made in France.
Oasis Tears Enforcement report

Harrow Eye, LLC is recalling 50,900 units of Freshkote eye lubricating drops (.33 fl ounce/10 mL), made in France, due to lack of assurance of sterility.
Freshkote Eye Drops Enforcement Report

Ocrevus Now Approved for Pediatric MS

Genentech’s Ocrevus (ocrelizumab) received expanded approval for treating relapsing-remitting multiple sclerosis (MS) in pediatric patients 10 years and older who weigh 25kilograms (55 pounds) or more. Previously, it was only approved for adults with MS.

It is rare for a child to have MS; only about 3-5% of people living with MS were diagnosed when they were under the age of 16; most are diagnosed in their 20s or 30s. After the first two doses administered two weeks apart, Ocrevus is administered intravenously (by IV) by a healthcare professional twice a year. Pediatric patients weighing 25 kg (55 pounds) to less than 35 kg (77 pounds) receive half the adult dose. Ocrevus was originally approved in 2017.
Multiple Sclerosis News Today: “FDA-approves-ocrevus-treating-children-10-older-relapsing-remitting MS” and FDA Supplemental Approval Letter for Ocrevus
Have you taken Ocrevus? Please add your rating or comments (no account or email needed) at Ask a Patient website.

Expanded Approval for Vyvgart for generalized Myasthenia Gravis (gMG)

Argenx BV’s Vyvgart (efgartigimod alfa-fcab) injection for intravenous use and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous use received expanded approval for treating generalized myasthenia gravis (gMG) in adult patients. Previously, it was only approved for adults with a specific antibody requirement (anti-acetylcholine receptor antibody (AChR-Ab) seronegative). Vyvgart was originally approved in 2021.

Generalized Myasthenia gravis is a rare, chronic autoimmune neuromuscular disease that disrupts communication between nerves and muscles, leading to muscle weakness that can affect speaking swallowing breathing and limb strength; the symptoms often fluctuate.
Muscular Dystrophy Association: “FDA Expands-approval-of-vyvgart-and-vyvgart-hytrulo-to-all-adults-living-with-generalized-myasthenia”
FDA Approval Letter

Have you taken Vyvgart? Read comments from others or add your experience at Ask a Patient website.

Parkinson’s Disease Diagnostic DATSCAN Warning

GE Healthcare’s DATSCAN (ioflupane I 123 injection), is a radioactive diagnostic agent used to help diagnose suspected Parkinson’s disease (PD) or dementia with Lewy bodies. It uses single photon emission computed tomography (SPECT) equipment to visualize the presence and pattern of dopamine neurons, which helps to make a diagnosis or rule out a diagnosis, since levels of dopamine are reduced in Parkinson’s patients.

The antidepressants venlafaxine (Effexor brand name) and desvenlafaxine (Pristiq), which help preserve dopamine in the brain, may affect DATSCAN imaging interpretation. The label was updated to add the antidepressants to the interacting drug lists. DATSCAN was originally approved in 2011.
DATSCAN Label Update and Revised Drug Label

Also, three Attention Deficit Hyperactivity Disorder (ADHD) drug labels were recently updated to warn of their potential interaction with DATSCAN imaging interpretations. These ADHD stimulant drugs work by increasing levels of dopamine in the brain, improving motivation. All are DEA Schedule 2 drugs because they have a high potential for abuse: Adderall XR Label Update, Mydayis Label Update, and Vyvanse Label Update

American Parkinson’s Disease Association: “What is a DaTscan and should I get one?”

The following medications should also be avoided before getting the imaging test: Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil, norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine. (listed on the DATSCAN label)

HHS Aims to Reduce Psychiatric Drug Prescribing

The U.S. Department of Health and Human Services (HHS) launched a new multi-agency program that aims to curb the overuse of psychiatric drugs and promote a more holistic approach to mental health. At the recent “Overmedicalization - Make America Healthy Again (MAHA)” event, panels of health care professionals, patients, mental health patient advocates, and government health officials provided testimony on such topics as prescription cascade, where adverse effects from one medication are often misinterpreted as new diagnoses, leading to the addition of more drugs.

Patients trying to stop taking their antidepressants shared that “rapid tapers” (short-term reduction in dosage amount) prescribed by health care providers have led to severe withdrawal effects, including having the withdrawal itself misidentified as a mental health relapse. The method of “hyperbolic tapering” (very gradual reduction in the dosage amount) was promoted by Dr. Mark Horowitz, a Clinical Research Fellow in Psychiatry who runs a deprescribing clinic in the UK. View his presentation (10 minutes long) or read the highlights, where he explains why this approach is safer:

Mark’s Substack

Hyperbolic tapering goes to Washington

Read more

2 months ago · 38 likes · 3 comments

Some have been critical of the HHS plan, saying that the most severe mental health conditions, such as schizophrenia, have been left out of the new initiative. Others point out that the paper released in conjunction with the initiative has some mistakes, including erroneous citations. The American Psychiatric Association (APA) released a statement that “while APA supports efforts to improve the quality, safety, and evidence base of mental health treatment, we strongly object to framing the nation’s mental health crisis as primarily a problem of ‘overmedicalization’ or ‘overprescribing.’ APA News Release

Substance Abuse and Mental Health Services Administration (SAMHSA): SAMHSA News Release on HHS Action Plan and “Dear Colleague” letter for clinicians
Drug Topics: HHS-Designs-Action-Plan-to-Address-Overprescribing-of-SSRIS

“Seeding” Clinical Trials’ Only Goal is to Increase Prescribing of Products

Researchers from University of California Santa Barbara and Cornell University analyzed over 34,000 industry-funded trials and found that hundreds of them were likely designed as “seeding trials,” a way to promote a drug to physicians rather than to collect scientific data. In a typical clinical trial, researchers recruit patients across clinics and hospitals to test whether a treatment is safe and effective. For a seeding trial, doctors may be selected to participate based on their prescribing volume rather than their research credentials.

Two prominent examples of seeding trials were Merck’s Advantage trial for the arthritis pain drug rofecoxib (Vioxx), which was later withdrawn from the market due to cardiovascular risks. Parke Davis’ STEPS trial in the late 1990s for epilepsy drug gabapentin (Neurontin) was designed to encourage doctors to write prescriptions for off-label use. Gabapentin is now the fifth most frequently prescribed generic drug in the country and still is only FDA-approved for partial onset seizures due to epilepsy and nerve pain caused by shingles. The study authors say that “these cases came to light only because litigation forced the release of internal company documents. Without that exposure, they would have remained indistinguishable from ordinary research.” Many more studies “are in the ambiguous middle ground, generating useful data while simultaneously serving promotional objectives.” The study was published in BMJ Evidence Based Medicine and is a feature article this month in “The Conversation.”

The Conversation: Clinical trials-that-are-actually-marketing-ploys: Targeting-doctors-how-seeding-trials-put-profit-over-patients

Have you taken gabapentin off-label? Read comments from others or easily add your experience (no account or email required) at Ask a Patient website.

Problems with AI in Medicine

Also: What Doctors Want to Know Most About Your Chest Pain

In a recent article, cardiologist and newsletter writer Dr. Gregory Katz talks about why he thinks A.I. in medicine is solving the wrong problems. For example, the “AI Scribe” tool does not work very well in his experience. It writes too much verbatim detail and sometimes adds wrong information, such as including notes about the doctor himself in the patient’s health history if the common phrase “how are you doing” (directed to the doctor) comes up during conversation. (Patients should always have an opportunity to opt-out of having their medical consultations documented with an automatic AI scribe.)

Katz observes that AI chatbots can answer questions, but do not ask the right ones. “Patients are often ineffective narrators about things that matter for diagnostic purposes…It’s not a patient’s job to know what details about chest pain matter.” To illustrate this, he references his article from last August “Why your doctor keeps interrupting you (and how to fix it).”

Many patients tend to focus on chest pain severity or the specific way it feels, such as being stabbing, crushing, dull, or burning. Dr. Katz explains that those pain descriptions are not as important as the pattern, the timing, and circumstances that make the pain better or worse. Answers to the following are the most important:

· Does it come on with activity or go away with rest?

· Is it worse when you breathe in?

· Is it worse lying down or sitting up?

· How long does it last?

· What have you tried to make it better or worse?

Some symptoms, such as shortness of breath while lying down, are red flags. Read the full story for more:

Greg Katz, MD

Why your doctor keeps interrupting you (and how to fix it)

"Doctor, I have this sharp, stabbing pain right here in my chest that feels like someone is sticking a knife into me…

Read more

10 months ago · 80 likes · 14 comments · Greg Katz, MD

Did you miss the last edition of the newsletter? Read it here:

Teva is recalling 124,054 cartons of high blood pressure treatment clonidine transdermal system (patch), .1 mg/day dosage, 62,136 cartons at the .2 mg dosage, and 113,943 cartons of the .3 mg strength dosage due to use of an unapproved raw material during manufacturing. The patches, packed four to a carton, were manufactured by Actavis in Salt Lake City, Utah and distributed by Actavis nationwide. Clonidine (Catapres TTS brand name) patch is applied to the skin weekly. While the recall is directed at retailers, consumers may check the recall report for more information.
FDA Recall Report

Xanax XR (alprazolam) Extended-Release Tablets Recall by Viatris

Viatris, Inc. is recalling one lot of 3 mg strength, 60-tablet bottles of panic disorder treatment Xanax (alprazolam) extended-release tablets because the tablets may not dissolve properly (failed dissolution specifications). The tablets were made by Viatris Specialty in Ireland and distributed nationwide by Viatris Specialty in Morgantown, West Virginia. (Lot# 8177156 with an Expiration Date of 02/28/2027)
FDA Recall Report

Additional recent recalls for private label cough drops, isotretinoin, and prazosin are listed at MedShadow Foundation’s recall roundup.

Health Fraud Scam: Arthritis and Pain Relief Supplements with Hyaluronic Acid

FDA is warning consumers not to purchase or use tablets or capsules labeled as containing hyaluronic acid, which are promoted and sold as supplements for arthritis pain relief on websites and possibly in some retail stores. Laboratory testing confirmed the products contain hidden drug ingredients not listed on the product labels. Note that these products are distinct from the hyaluronic acid-containing creams and serums marketed for skin care.
FDA Alert: “Hyaluronic-acid-products-containing-undeclared-ingredients”

Health Fraud Scam: Addall XR Shot and Capsules

FDA is warning consumers not to buy or use Addall XR Shot or Capsules, marketed as dietary supplements to improve focus, using a confusing brand name similar to the FDA-approved ADHD drug Adderall. Laboratory testing found that the orange-flavored Addall XR Shot contains Phenibut (β-phenyl-GABA), an unlawful and dangerous ingredient in dietary supplements, as well as undeclared 1,4-DMAA (1,4-dimethylamylamine). The Addall XL 30 capsules contain the undeclared and unlawful ingredients 2-amino-6-methylheptane (DMHA) and 1,4-DMAA. Phenibut can cause fatigue, balance problems and potential addiction. DMAA and DMHA may cause cardiovascular problems such as high blood pressure or even heart attack. The products are sold online and at retailers such as gas stations and convenience stores nationwide.
FDA Alert: “FDA-advises-consumers-retailers-and-distributors-not-eat-sell-or-distribute-addall-xr-shot-or-addall”

Proscar Warning About Reports of Suicidal Thoughts

Proscar (finasteride), a treatment for benign prostatic hyperplasia (enlarged prostate), added a warning to its label about the risk of suicidal ideation, or thoughts of self-harm or suicide. The medication guide advises that patients taking Proscar should tell their healthcare provider right away if they notice new or worsening depression, mood changes, or suicidal thoughts. Proscar tablets were approved in 1992.

Hair loss drug Propecia, which also contains finasteride, has far more reports of suicidal ideation than does Proscar; a warning was added to its label in 2022. The Ask a Patient database of medication ratings and reviews contains 90 reports of depression or suicidal thoughts associated with Propecia.

Reports of anxiety with Proscar are common; anxiety is the 7th most frequently reported adverse event (400 reports for the side effect out of about 3000) for Proscar in the FDA adverse events database.

FDA Proscar Safety Update

Eylea Long-Term Increased Incidence of Stroke and Heart Attack

Eylea HD (aflibercept), a high dose (8 mg) treatment approved in 2023 for four eye diseases including wet age-related macular degeneration, updated its label to add clinical trials results for a long-term (96 weeks) study comparing it with regular 2 mg Eylea. The drug is administered directly into the eye (intravitreal injection) by a healthcare professional.

The trial results showed an increase in the incidence of thromboembolic events (ATEs) over time, but the HD 8 mg formulation, which is given less frequently (every 12 or 16 weeks), had less incidence of the events than regular Eylea 2 mg formulation, which is administered every 8 weeks. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction (heart attack), or vascular death (including deaths of unknown cause). The incidence of ATEs experienced during clinical trials depended on the indication being treated. The following provides the incidence levels by the type of disease being treated:

• Wet AMD: 1.8% (12 out of 673 patients) for Eylea HD vs. 3.3% (11 out of 336) for Eylea 2mg

• Diabetic Macular Edema: 6.7% (33 out of 491) for Eylea HD vs 7.2% (12 out of 167) for Eylea 2mg

• Macular Edema Following Retinal Vein Occlusion through week 36 (a different study): 0.5% (3 out of 591) for Eylea HD vs. 1.7% (5 out of 301) for Eylea 2 mg

The revised label for Eylea HD has additional clinical trial results information.
FDA Eylea HD Safety Update

Read more about age-related macular degeneration (dry and wet), and diabetic retinopathy at the National Eye Institute.

2025 Vulnerable Medicines List and Potential Shortages

The U.S. Pharmacopeia (USP) is a quality standards organization for medicines, dietary supplements, and excipients (inactive ingredients that help deliver the active ingredients in a medicine). USP recently published its annual list of 100 Vulnerable Medicines, a list of clinically important medicines with the most supply chain vulnerabilities that may lead to shortages in the U.S. “Supply chain vulnerabilities are particularly acute when production of key inputs is geographically concentrated or limited to a small number of suppliers,” notes the report.

The majority of at-risk drugs (63%) are injectables, which are always prone to shortages due to their unique production challenges. Oral solid drugs, such as tablets and capsules, represent the second-largest at-risk group at 22%.

Tablets and capsules on the list include at least six that are currently in shortage (noted below with a link to the current shortage report):

Morphine Tablets, Oseltamivir Capsules, Oxycodone Hydrochloride Immediate-Release Tablets (currently in shortage) Isoniazid, Irbesartan, Lisdexamfetamine (ADHD drug in shortage), Amphetamine Aspartate, Amphetamine Sulfate, Dextroamphetamine Saccharate and Dextroamphetamine Sulfate Tablets, Amphetamine Mixed Salts Tablets, Extended-Release Clonazepam Tablets (seizure drug now currently in shortage) Disulfiram Tablets, (used for alcohol addiction), Oseltamivir Capsules and Oral suspension (generic for Tamiflu and in shortage), Methylphenidate immediate and extended release (in shortage) and leucorvorin calcium tablets (in shortage).

View the complete USP vulnerable-medicines-list-2025 (11-page PDF download)

Biospace: “USP-adds-tamiflu-trulicity-to-vulnerable-list-as-upstream-analysis-reshapes-supply-concerns”

Drug Sponsors Reminded to Disclose Clinical Trial Results

The FDA sent notices to more than 2,200 drug and medical product sponsors and researchers (associated with more than 3,000 registered clinical trials, including some that were publicly funded) reminding them of their obligation to submit clinical trial results information to ClinicalTrials.gov, a public database run by the National Institutes of Health’s National Library of Medicine. Trial sponsors, with few exceptions, are required to submit clinical trial results information to ClinicalTrials.gov within one year after trial completion.

According to an internal analysis, FDA says that about 30% of studies that are highly likely to fall under mandatory reporting requirements have not reported any results to ClinicalTrials.gov.

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community. Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price,” said FDA Commissioner Marty Makary.

What comes next if the companies or researchers don’t send in the trials results? The FDA may send Pre-Notices of Noncompliance and Notices of Noncompliance, and may impose fees as part of risk-based compliance efforts. However, in practice the FDA has rarely sent Notices of Noncompliance or levied fees. The messages recently sent to the trial sponsors, which were not made public, “represent an extra step the agency is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action.”

FDA Press Release: FDA-reminds-more-2200-sponsors-and-researchers-to disclose-trial-results

Fierce Biotech: FDA -urges-clinical-trial-sponsors-report-results-their-studies

Foundayo’s Rapid Approval and Safety Concerns

Eli Lilly’s new GLP-1 pill for weight loss, Foundayo (orforglipron) was approved on April 1, in a record 50 days under the Commissioner’s National Priority Review pilot program, but FDA’s safety concerns are evident based on the number of required post-approval clinical trials.

When Lilly’s Mounjaro (tirzepatide) GLP-1 medication was approved in 2022, only three post-approval trials were mandated: the standard pediatric trial, a registry-based monitoring study for thyroid cancer (all GLP-1 drugs carry a black box warning for the risk of thyroid tumors), and a lactation study to assess concentrations of tirzepatide in breast milk.

In contrast, the Foundayo (orforglipron) approval letter identifies nine required post-approval studies, including the three that were required of Mounjaro, plus two additional pediatric studies, a pregnancy complications study, a pregnancy exposure registry, a heart attack and stroke and liver injury study, and a delayed gastric emptying study that uses ultrasound to monitor the effects of fasting on stomach contents. Favorable results for the cardiac and liver injury trial will help pave the way for Foundayo’s approval for a Type 2 diabetes indication.

New Favorable Safety Data for Foundayo as Diabetes Treatment

Biospace reported that Lilly’s newly released diabetes data comparing insulin vs. Foundayo showed that the risk of all-cause death to be 57% lower for participants receiving Foundayo and showed 16% lower A1C levels compared to insulin.

Also, the 52-week trial showed “no signs of drug-induced liver injury (DILI), which should assuage FDA concerns about unexpected cases of major adverse cardiovascular events and liver injury.”
Biospace: “Lilly’s Foundayo posts Outstanding Diabetes Data Possibly Easing FDA Safety Concerns”

Weight Loss Results Study and Side Effects

A Novo Nordisk-sponsored study presented at the Obesity Medicine Association’s annual conference showed that Foundayo (36 mg) was associated with around four to 14 times higher odds of treatment discontinuation due to adverse effects compared with semaglutide (Wegovy, 25 mg). It also suggested that the maximum strength Wegovy produced greater average weight loss compared with Foundayo.

Healio: “Obesity Medicine Annual Conference: Semaglutide tied to greater weight loss vs orforglipron”
An included perspective on the study from Fatima Cody Stanford, Healio Primary Care Peer Perspective Board Member suggests that because this is an indirect study, not a head-to-head comparison, results should be interpreted with caution.

An Eli Lilly sponsored study (published in the Lancet) and reported in our March 8 newsletter, showed greater weight loss with orforglipron than semaglutide, but the semaglutide used in the study was the Rybelsus lower dose (7 or 14 mg). Orforglipron users were more likely than semaglutide users to discontinue the drug because of side effects.

Research: Early Stage Lung Cancer Surgery Safe for Many Patients Over 80

Researchers at the Icahn School of Medicine and the Mount Sinai Tisch Cancer Center in New York found that adults aged 80 and older with early-stage lung cancer can safely undergo surgery and achieve outcomes comparable to younger patients, challenging longstanding assumptions about age and cancer treatment. “As our population ages, more patients over 80 are being diagnosed with early-stage lung cancer, yet they are often not considered for surgery,” said lead researcher Raja M. Flores, MD, Chair of the Department of Thoracic Surgery at Mount Sinai Health System. “Our findings show that when patients are carefully selected based on their overall health, not just their age, they can tolerate surgery well and experience excellent long-term outcomes.”

The study followed 884 patients with early-stage lung cancer, including 114 people who were age 80 or older, finding that older patients lived just as long as younger patients after surgery. While some older patients had more complications right after surgery, most patients in both groups felt better over time, and their quality of life improved within a year. The findings were published in The Lancet Regional Health – Americas.
Mount Sinai Press Release: Mount-sinai-study-finds-lung-cancer-surgery-safe-for-many-patients-over-80

Supplement Tips: Fish Oil Capsules Safety

Consumer Reports recently tested 20 popular fish oil supplements for safety and quality standards, including testing for heavy metals and contaminants. Sixteen of them passed, but these four 1000 mg “softgels” products did not meet label claims for omega-3 fatty acid content or showed signs of rancidity: Kirkland Signature (Costco) fish oil softgels, Nature Made Burp-Less Fish Oil Softgels, California Gold Nutrition (Kids Omega-3 Fish Oil Softgels, Strawberry), Qunol Ultra Omega-3 Mini Softgels.
Read the complete report for more insights into fish oil supplements.
Consumer Reports: “What’s in Your Fish Oil Pill?” (April 1, 2026)

Did you miss the last edition of the newsletter? Check it out here:

KC Pharmaceutical, a Pomona, California-based manufacturer and major supplier of private label eye products, has recalled 3.1 million bottles of eye drops nationwide because of sterility concerns. This could be due to a problem with sterile aseptic equipment or a lapse in sterile conditions at the KC manufacturing facility: the exact reason is not provided in the FDA Enforcement Report. KC Pharmaceutical’s manufacturing facility was been cited for sterility violations in the past and received a warning letter in 2023.

Over-the-counter eye drops with labels under the names of Kroger, Harris Teeter, H-E-B, Publix, Meijer, CVS, Rite Aid, Walgreens, Dollar General, Cardinal Health, Goodsense, Foster and Thrive, Leader, and others are included in the recall.

The FDA reports that eight separate products (all are .5 fluid ounce or 15 mL container) are under recall with the following names, ingredients, and quantities:

• Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6): 589,000 bottles

• Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%): 1,023,096 bottles

• Eye Drops Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%): 303,216 bottles

• Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%): 182,424 bottles

• Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%): 378,144 bottles

• Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%): 315,144 bottles

• Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.30): 74,000 bottles

• Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%): 245,184 bottles

All of the affected products under recall have expiration dates in 2026 and are branded with various retail stores or private label brand names. This recall is directed at retail suppliers, but you may check the recall report for lot numbers to find out if your eye drops are included in the recall.
FDA Recall Enforcement Report

Bromfenac Eye Drops Recall by Alembic

Alembic Pharma is recalling Bromfenac ophthalmic solution 0.07, prescription eye drops for postoperative inflammation and eye pain in patients who have undergone cataract surgery. The recall is due to “failed Impurities/Degradation Specifications” when tested at 20 months. The product was manufactured in Gujarat, India. All of the affected lots expired in March 2026 except lot # 7240278, which expires in May 2026.
FDA Recall Enforcement Report

Levothyroxine Sodium Tablets Recall by Macleods

Macleods Pharma USA is recalling 1,315 bottles of 150 mcg Levothyroxine Sodium Tablets (1000-count) because the tablets may be subpotent, or contain less than the specified amount of the active ingredient. Levothyroxine treats hypothyroidism (underactive thyroid). The recalled medicine was made by Macleods in Valsad, Gujarat, India. The lot number of the affected product is 16240062A with an expiration date of March 2026.
FDA Recall Enforcement Report

Thyroid Medications Regulation: Alternative Medicines for Hypothyroidism

While most people with hypothyroidism (underactive thyroid) and Hashimoto’s (a thyroid-specific autoimmune disease) are fine taking the synthetic version of levothyroxine, (either a generic or Synthroid brand name), some patients only find symptom relief from natural versions of the thyroid hormone, called “desiccated thyroid” (dried porcine thyroid gland). For these patients, the naturally derived medication more closely mimics thyroid gland hormones.

Last August, the FDA sent warning letters to companies marketing naturally-derived thyroid hormone (such as Armour Thyroid or NP Thyroid) stating that the medications were not FDA approved and that the FDA would require approval within a year. To the relief of many patients and the drug makers, on March 18, 2026 the FDA updated its position to allow continued sale of the drugs while they work out the details of assuring product quality and safety by moving towards FDA approval of the products.

Natural thyroid options include Armour Thyroid and NP Thyroid. Also, several compounding pharmacies recommended by Mary Shoman’s website prepare natural thyroid medicines tailored to your requirements, including options for patients who used Nature-Thyroid or WP Thyroid brands, which are no longer available and use different active ingredients than Armour Thyroid or NP Thyroid.

Updated FDA Announcement from March 2026: FDA’s Actions to Address Unapproved Thyroid Medications

Read more about hypothyroidism at Medline Plus

New Warnings for Cleocin (Clindamycin Phosphate and Clindamycin HCL)

Cleocin (clindamycin), a common antibiotic, has a new warning about heart problems that can occur as part of an allergic reaction to the drug. The label now warns that acute myocardial ischemia (reduced blood flow to the heart) has been reported with or without myocardial infarction (heart attack) as part of an allergic reaction. Cleocin was originally approved in 1970.

Safety Updates: Cleocin HCL FDA Safety Label Update and Cleocin Phosphate FDA Safety Label Update

Kidney Injury Warning for Alli (Orlistat) Capsules

At the request of the FDA, over-the-counter weight loss drug Alli (orlistat) is adding warnings about the risk of kidney injury to the “Drug Facts” section on the packaging. Patients who have (or had) kidney disease are instructed to “Ask a Doctor Before Use.” Patients are warned to stop using the medication if they experience symptoms of kidney injury including pain in the back or groin, painful urination, blood in urine, swelling of the legs or feet, or are urinating less often than normal. Because Orlistat works by preventing the absorption of fat, it may reduce the absorption of vitamins from food. Patients are advised to take a multivitamin supplement and to eat a well-balanced, low fat diet.

Xenical (orlistat 120 mg) and generic orlistat is a prescription medication for weight loss, approved in 1999. Xenical already includes a warning about the risks of kidney disease. Alli was approved as an over-the-counter lower dose orlistat version (60 mg) in 2007.
Alli FDA Safety Label Update

Health Tips: New Cholesterol Guidelines: Have you had your Lipoprotein(a) Levels Checked?

The American College of Cardiology (ACC), the American Heart Association (AHA), and nine other medical associations recently updated the 2018 cholesterol management guidelines (“2018 AHA/ACC Guideline on the Management of Blood Cholesterol”), with the “2026 Guideline on the Management of Dyslipidemia.”

The new guidelines emphasize earlier screening, more types of screening tests, healthy lifestyle, monitoring blood pressure, and selective use of medications to lower the risk of atherosclerotic cardiovascular disease (ASCVD), which can lead to heart attacks and strokes. Here are some highlights:

Lipoprotein a test

The new guidelines say that everyone should be tested for Lp(a) at least once in their lifetime. Lipoprotein(a) is an inherited type of LDL that accelerates plaque formation, promotes inflammation, and makes blood more likely to clot. Patients with Lp(a) levels at or above 125 nmol/L (50 mg/dL) have a 1.4-fold increased risk of ASCVD, and the risk doubles at values at or above 250 nmol/L (100 mg/dL) and quadruples at values at or above 430 nmol/L (180 mg/dL).

Repeating the test usually isn’t needed because results tend to be stable over time. Because Lp(a)-lowering treatments aren’t available, patients with elevated levels may be advised to consider taking LDL-C (bad cholesterol) lowering treatments and try to minimize their other heart disease risk factors.

Coronary Artery Calcium (CAC) CT scans

CAC scans are recommended in men 40 years or older and in women 45 years and older with borderline or intermediate 10-year risk of heart attack or stroke if knowing CAC will help with the decision to prescribe a statin or not.

Medications Guidance and Risk Calculator

New guidelines say you should take statins if you are age 40 to 75 years old with diabetes, have stage 3 or 4 kidney disease, or have human immunodeficiency virus (HIV), even if you have normal LDL levels. Otherwise, it depends on your LDL levels and your other risk factors. According to the new guidelines, to prevent a first heart attack or stroke, the LDL-C goal should be less than 100 mg/dL for those at borderline or intermediate risk and less than 70 mg/dL in those at high risk. For individuals with ASCVD who are at very high risk, the LDL-C goal should be less than 55 mg/dL for secondary prevention of cardiac events.

The guidelines recommend the use of a new cardiovascular disease risk calculator (the American Heart Association’s PREVENT-ASCVD calculator) to compute risk scores, but using the scores to make treatment decisions is controversial because there are many factors not taken into account in the calculation that can affect an individual’s risk.

American Heart Association: “What Your Cholesterol Levels Mean” and Press Release on the New Guidelines

Dr. Lucy McBride and Cardiologist Dr. Greg Katz talked about the new cholesterol guidelines in a recent podcast: “What the New Cholesterol Guidelines Mean for You: A Conversation with NYU Cardiologist Dr. Greg Katz”
“Together, they cut through the noise on coronary artery calcium scores, Lp(a), statins, GLP-1s, and the lifestyle factors that matter most for heart health. The upshot: we treat people, not numbers.”

When is a Statin Needed?

Dr. Lucy McBride, writer of “Are You Okay?” recently answered a reader-submitted question about statins and cholesterol levels:

A 42-year old reader has normal cholesterol except for an LDL of 135. She feels fine and eats a fairly healthy diet but is concerned because her doctor wants her to take a statin. Does she really need to take one?
Question and Answer - do I need to take a statin

Did you miss our last edition? Check it out here:

Strides Pharma is recalling almost 90,000 bottles of over-the-counter Children’s Ibuprofen liquid formulation due to a consumer finding a gel-like mass and black particles in the product. The medication was made in India for Taro Pharma USA. Check this Enforcement Report for lot numbers and expiration dates.

Glaucoma Eye Drops Recall by Apotex

More than 107,00 vials (5mL) of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because of the lack of assurance of sterility. This is for the 0.2%/0.5% strength medication, and the severity of the recall has not yet been classified by the FDA. Apotex 2026 Recall
In October 2025, Apotex had another large recall (still ongoing) of over 150,000 eye drop bottles of brimonidine tartrate/timolol maleate along with 493,000 bottles of prescription Ketorolac Tromethamine eye drops for allergies.
Ask a Patient News: Eye Drops by Apotex Recalls Fall 2025

Two Dietary Supplements Recalled Nationwide

Anthony Trinh, 123Herbals LLC is recalling 25-count bottles of Silintan capsules, which it sells as a dietary supplement for pain relief. FDA detected that the product contains undeclared meloxicam, a prescription nonsteroidal anti-inflammatory drug (NSAID) for arthritis. This medication can have serious side effects and drug interactions. Read the FDA Enforcement Report and FDA Press Release for Consumers for more details.

Also, a dietary supplement marketed for male enhancement, MR. 7 SUPER 700000 Capsules, sold online by StuffbyNainax, is under a Class I recall. The FDA detected that the product contains undeclared sildenafil and tadalafil, prescription-only ingredients used to treat erectile dysfunction. Read the FDA Press Release for Consumers and FDA Enforcement Report for more details, including the serious risks associated with taking these supplements.

Drug Warning: Parkinson’s Drug and Seizures from Vitamin Deficiency

The FDA issued a Drug Safety Communication regarding Parkinson’s medications containing carbidopa/levodopa, stating that after a safety review, it determined that the drugs can deplete vitamin B6 levels, resulting in a vitamin deficiency that can lead to seizures. Products that will soon carry a new warning about the risk include carbidopa/levodopa, Rytary, Sinemet, Sinemet CR; carbidopa/levodopa/entacapone (Stalevo), foscarbidopa/foslevodopa (Vyalev). These products include multiple formulations and may be administered by several different routes, including oral tablets, an enteral (intestinal) suspension, and a subcutaneous injection.
FDA Safety Communication: “FDA Requiring Warning About Vitamin B Deficiency and Associated Seizures in Drug Products Containing Carbidopa/Levodopa”

Xeljanz and Risk of Infections, Fractures

Rheumatoid Arthritis (RA) drug Xeljanz (tofacitinib) expanded warnings about the serious risk of infection. It also added new data from a clinical trial safety study of adults with Rheumatoid Arthritis that tested higher doses of the drug (10 mg twice a day) compared with lower doses (5 mg twice a day) and TNF blockers. Xeljanz, and Xeljanz higher dose were associated with a higher risk of fractures than the TNF blocker. Given these increased risks, Xeljanz (tablets and oral solution) 10 mg twice daily or XELJANZ XR (extended-release tablets 22 mg once daily) dosages are not recommended for the treatment of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing spondylitis (AS), or polyarticular course juvenile idiopathic arthritis (pcJIA).

Topamax Migraine Drug and Serious Skin Reactions

Migraine and seizure drug Topamax (topiramate), along with other topiramate-containing drugs, have new warnings that severe hypersensitivity reactions, including anaphylaxis and skin swelling. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has also been reported in patients taking topiramate. DRESS may be fatal or life-threatening.

At the FDA’s request, the labels for Topamax, Eprontia, and Trokendi XR were updated to warn about these risks. Topamax is approved to treat epilepsy/seizures in patients age 2 and up and as a preventive migraine treatment for age 12 and up. It was originally approved in 1996.

Ozurdex (dexamethasone) Intravitreal (Eye) Implant Warning

Ozurdex is an eye implant that releases the drug dexamethasone (a steroid) to treat three serious eye conditions: diabetic macular edema (complication of diabetes that can cause blindness), non-infectious uveitis (inflammation in central section of the eye), and central retinal vein occlusion, which is blockage of the small veins that carry blood away from the retina.

Ozurdex drug label was updated to warn about the risk of “corneal decompensation” that could happen if the device is dislocated. Corneal decompensation happens when the cornea loses its ability to maintain proper hydration and clarity, and causes swelling and cloudiness. This can lead to vision problems and may require additional treatment. Instructions for device insertion were revised. After implanting the device, patients should be monitored for elevation of eye pressure and for endophthalmitis, a serious eye infection. Ozurdex was approved in 2009.

Read more about uveitis at Mayo Clinic: Uveitis Symptoms and Causes

Read more about diabetic macular edema at Mayo Clinic: Screening for diabetic macular edema

Read more about retinal vein occlusion at Medline Plus.

Children’s Xyzal (levocetirizine) and Severe Withdrawal Itching Side Effect

In a letter, FDA approved the revision to Children’s Xyzal Allergy 24 Hour oral solution over-the-counter packaging to add a warning about the risk of extreme itching (“new onset pruritis”) to be added to the product’s “Drug Facts.” The FDA requested this change in July 2025 and recognized the side effect, which is a type of withdrawal effect associated with long-term use of prescription and over-the-counter allergy medicines cetirizine (Zyrtec) and levocetirizine (Xyzal) in a Drug Safety Communication in May 2025. For years, anecdotal reports of the withdrawal itching side effect have been received through sites like Ask a Patient and People’s Pharmacy and through the FDA’s adverse events reporting system.

Prescription products had the new warnings first, beginning last year: Xyzal levocetirizine dihydrochloride tablets and withdrawal itching and “Beware of Itching After Discontinuing These Allergy Drugs”

Sivextro Antibiotic and Serotonin Syndrome

Antibiotic Sivextro (tedizolid phosphate) added a warning about the risk of serotonin syndrome when Sivextro is taken with certain drugs. Serotonin syndrome is a potentially life-threatening condition with symptoms including fever, sweating, agitation, unusual eye movements, difficulty with coordination, stiff muscles, and twitching.

Drugs (serotonergic agents) include antidepressants, prescription opioid pain medications, anxiety medications, methotrexate, topotecan, rosuvastatin, and some migraine headache medications. Patients taking these drugs along with Sivextro should be monitored for signs and symptoms of serotonin syndrome.

The label was also updated with the side effect of Clostridioides difficile-associated diarrhea and replaced the pediatric age specification for tablets (age 12) with a weight specification of at least 77 pounds (35 kg). Sivextro is administered by I.V. or in tablet form and treats skin and skin structure infections in children and adults. It was approved in 2014.

The antibiotic Linezolid (Zyvox brand name) is a similar antibiotic to Sivextro – both are synthetic “oxazolidinone” antimicrobial agents. FDA issued a drug safety communication related to Zyvox in 2011: Risk of Serotonin Syndrome and Linezolid Zyvox

Antibiotics Research: Azythromycin Not Helpful for Covid

University of California San Francisco researchers found that the routine use of the antibiotic azithromycin (Zithromax brand name) in hospitalized patients during the COVID-19 pandemic had no clinical benefit and was associated with potentially harmful changes in the upper respiratory microbiome. The researchers found an increase in the expression of antibiotic-resistant genes after just one day of exposure to the antibiotic. Alarmingly, it was found was that patients who received azithromycin had a reduced presence of some harmless bacteria and an increased presence of pathogenic species, such as Staphylococcus and Klebsiella, and more “detectably expressed,” or active, macrolide resistance genes in their upper airway. The study was published in Nature Microbiology.
CIDRAP: “Antibiotic used in COVID patients tied to increased signs of antibiotic resistance”

Antibiotics Research: Effects on the Gut Microbiome Can Last for Many Years

Researchers at Uppsala University, Karolinska Institutet, and Lund University studied how antibiotic use affects the gut microbiome over time. The study, based on drug registry data and genetic analysis of fecal samples from nearly 15,000 Swedish residents, found that people who took certain oral antibiotics had fewer bacterial species in their gut, and a lower abundance of individual species of gut bacteria, for four to eight years after taking them.

The antibiotics most strongly associated with these long-lasting effects were clindamycin, fluoroquinolones, and flucloxacillin. Some patients can have problems with their gut, such unexplained diarrhea, irritable bowel, or inflammatory bowel conditions, for many years after just taking one course of antibiotics. The findings were published in Nature Medicine.

CIDRAP: “Antibiotic use linked to ‘persistent’ gut microbiome changes”

Related: Dr. Lucy McBride just answered a question on Friday from a reader who likely read this same research - Should a patient be worried about long-term disruption to the gut microbiome if she gets a new antibiotic prescription for a sinus infection?

Metformin Potential for Cancer Prevention

Type 2 diabetes drug metformin was first approved under the name Glucophage in Europe in the 1950s and is emerging as a “wonder drug.” It has been studied for treating Long Covid, improving longevity, lowering dementia risk for those with type 2, as a treatment for kidney disease, for lung conditions like COPD, and more. Joe Graedon of People’s Pharmacy recently updated his article on metformin and cancer.

He says that while there is conflicting data for whether taking metformin makes any difference for prostate cancer, recent research in JAMA Network Open, March 16, 2026 has encouraging news about metformin and esophageal cancer. The scientists report that people taking metformin had a 36% lower likelihood of being diagnosed with esophageal squamous cell carcinoma than those who were not taking it. Higher doses were associated with even lower risk, about 48%.

The People’s Pharmacy: “Should Everyone Be Taking Metformin to Fight Cancer?”

New Medications Roundup: Wegovy HD, Leucovorin, Plaque Psoriasis Pill, Meds for Liver-Related Itching, Growth Drug for Kids with Achondroplasia

Check out the key facts about recent new FDA drug approvals and expanded drug approvals at our website.
AskaPatient.com: “Recent Drug Approvals: Wegovy HD, Leucovorin, Plaque Psoriasis, Liver-Related Itching Meds, More”

Did you miss our last newsletters from March 8? Check them out here:

Teva is recalling more than 100,000 bottles (100-count or 1000-count) of metoprolol succinate extended‑release tablets, ranging from 25 mg to 200 mg strength, because some batches failed “dissolution” testing. The pills may not dissolve properly, causing potential loss of effectiveness. This recall is directed at suppliers, not consumers, but consumers may wish to check the FDA announcement for lot numbers and expiration dates. Metoprolol is a beta blocker used to treat high blood pressure.
FDA Recall Announcement

Amantadine Hydrochloride Capsules Recall by AvKare

AvKare is recalling 100 mg strength Amantadine Hydrochloride Capsules (liquid filled), 50 Capsules (5 x 10) unit dose, because of “failed dissolution specifications.” The capsules may not dissolve properly, causing potential loss of effectiveness. This recall is directed at suppliers, not consumers, but consumers may wish to check the FDA announcement for lot numbers and expiration dates. Amantadine HCL is used as prophylaxis and treatment for influenza and also treats symptoms of Parkinson’s disease and drug-induced extrapyramidal reactions.
FDA Recall Announcement

Temozolomide Capsules Recall by Rising Pharma

Rising Pharmaceuticals is recalling 1,200 bottles of 5mg strength Temozolomide capsules due to quality problems for “Failed Impurities/Degradation Specifications” during 9-month long term stability testing. The capsules were manufactured in Taiwan. This recall is directed at suppliers, not consumers, but consumers may wish to check the FDA announcement for lot numbers and expiration dates. Temozolomide treats brain cancer, including glioblastoma.
FDA Recall Announcement

iKids Growth Capsules by Agebox Recall and Warning

Agebox is recalling 665 bottles (60-count) of iKids-Growth (Day Formula) capsules, and an undisclosed number of iKids-Growth (Night Formula) capsules (60-count) bottles because of the presence of undeclared ibutamoren, an unapproved growth hormone stimulator. FDA lab tests confirmed that iKids-Growth product contains ibutamoren (MK-677). Ibutamoren is also considered an “underground gym pill,” popular in bodybuilding for boosting muscle and growth hormone.

The FDA states that ibutamoren can trigger serious side effects like increased appetite, swelling from water retention, tiredness, muscle aches, blood sugar changes that affect insulin, and may increase the potential for congestive heart failure in certain individuals. Agebox is a US brand first launched in China in 2022. In China, it promotes the product as an IGF-1 sensitizer for kids who are taller than the clinical short-stature threshold. Those who meet the clinical short-stature threshold may be prescribed growth hormone drugs like somatropin. Agebox claims to have more than 40,000 users in China with a 70% repurchase rate, and it is running clinical trials in China.

This is a very expensive supplement, selling for $799 for one set (2 bottles) of the day and night products on Amazon, which says it was first available in July 2025. Patients are instructed to take 2 capsules in the morning and 2 capsules at night.

In September 2025, FDA issued a consumer alert about the product, and in December 2025 sent a warning letter to the company and posted the recall enforcement report for the product on March 3, 2026.

FDA Recall Announcement

Artri Ajo Rey and Artri Ajo King Arthritis Pain Supplement Warning

The FDA updated its warnings about Artri Ajo Rey and Artri Ajo King, sold as natural arthritis relief supplements on websites and retail stores.

FDA testing revealed that the products contain prescription drugs: dexamethasone (a steroid), diclofenac (an NSAID), and methocarbamol (a muscle relaxant). These hidden ingredients, not listed on the supplement label, pose serious risks like infections, high blood sugar, adrenal problems, heart issues, stomach bleeding, drowsiness, low blood pressure, and even death, particularly when mixed with other meds or used long-term.

Any of the drugs under the “Artri” label should be avoided. Warnings about these popular products began in 2022. Many consumers have experienced a serious health effect after using unapproved over-the-counter products with “Artri” or “Ortiga” in the product name. Reported harmful effects include sudden weight gain, serious gastrointestinal damage including bleeding and ulceration, increased blood glucose (sugar) levels, adrenal dysfunction, liver toxicity, and other serious conditions. Painflex Forte and others

FDA Notice covering January 5, 2022 with the most recent update on March 3, 2026: Artri-ajo-rey-and-artri-ajo-king-may-be-harmful-due-hidden-drug-ingredients
The FDA maintains a list of more than 53 arthritis treatments sold as supplements that contain hidden ingredients:
FDA Medication Health Fraud: Pain-and-arthritis-products-containing-hidden-ingredients

El Tecolote: Despite FDA warnings, this ‘supplement’ remains popular among S.F. immigrants “The product, sold under names such as ‘Artri King,’ is widely used by Latinos for bone pain, but doctors say it can cause hormonal dysfunction and worsen diabetes.”

The following drugs’ labels were recently updated with new warnings:

Entyvio (vedolizumab) subcutaneous, by injection, and intravenous

Ulcerative Colitis (UC) and Chron’s disease treatment Entyvio (vedolizumab) broadened its warnings about the risk of developing infections. Cases of systemic bacterial, fungal, viral, and parasitic opportunistic infections have been reported. In clinical trials, serious infections included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. The label warns that treatment should not be initiated in patients with a “clinically important” active infection until the infection resolves or is adequately treated. Tuberculosis testing before starting treatment should be considered. Entyvio was approved in 2014.
Entyvio Safety Label Update

Paxlovid (nirmatrelvir; ritonavir) tablets

Covid-19 treatment Paxlovid (nirmatrelvir; ritonavir) should not be taken with the non-opioid pain drug Journavx (suzetrigine) as it may dangerously elevate the level of suzetrigine in the system. Paxlovid has a long list of contraindicated and “to avoid” drugs. Check the medication label or this FDA Patient Eligibility Screening Tool for a complete list. Paxlovid is co-packaged as nirmatrelvir and ritonavir tablets that are taken together; it was approved in 2023.
Paxlovid Safety Label Update

Vabomere (meropenem and vaborbactam) for injection, for intravenous use

Vabomere, a hospital-administered treatment for complicated urinary tract infections, has a new warning about the risk of drug-induced liver injury (DILI), including hepatitis and liver failure. Vabomere was approved in 2017.
Safety Label Update for Vabomere

Visit our website at www.askapatient.com for drug ratings and reviews contributed by patients.

Did you miss the other section of today’s newsletter? Find it here:
March 2026 New Drug Approvals and Research

Granules Pharmaceuticals is recalling 71,424 bottles (100-count) of 50 mg strength Trazodone Hydrochloride Tablets. Some 25mg strength Metoprolol Succinate ER tablets, bearing the imprints “I” and “25,” were found inside the bottles from batch 6160008A with an expiration date of December 2026. The pills were manufactured by Granules India Limited in Hyderaba India. Trazodone is a selective serotonin reuptake inhibitor (SSRI) approved to treat depression and also often used for insomnia. Metoprolol succinate extended-release is a drug to treat high blood pressure or hypertension.
Link to FDA Enforcement Report

Abbott Recalls Continuous Glucose Monitor Sensors for Freestyle Libre 3 and Libre 3 Plus System

The FDA announced a Class 1 recall (the most serious type) for almost 3 million continuous glucose monitor (CGM) sensors, part of the Freestyle Libre 3 and Libre 3 Plus CGM systems. So far, 860 serious injuries and seven deaths related to these products have been reported. These sensors may give false low glucose warnings, sometimes leading users to skip insulin or increase sugar intake, resulting in life threatening consequences. Until they receive replacement sensors for their CGM systems, patients are urged to use a separate blood glucose meter to measure glucose levels.

During inspections at the Abbott Diabetes Care facility in Alameda, California in in October 2025, FDA found, among other violations, that “contract manufacturers responsible for final assembly and release were not provided accuracy performance specifications and were not required to verify finished-device accuracy performance prior to release.” The enforcement report states that the problem was “due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results.”
Recall Information: FDA Press Release and Abbott Diabetes Care Warning Letter

Rybelsus Tablets Rebranded as Ozempic Tablets

Novo Nordisk has rebranded one version (containing 1.5 mg, 4 mg and 9 mg strengths) of its Rybelsus (semaglutide) tablets as Ozempic tablets. Rybelsus-branded pills will still be available in the 3 mg, 7, mg and 14 mg strengths. Rybelsus and Ozempic tablets are approved to treat Type 2 diabetes and to reduce the risk of heart attacks and strokes in high risk Type 2 diabetes patients. The rebranding is convenient for Novo Nordisk, since the tablets were already approved (since 2019) and only a name change was made. Wegovy, approved for weight loss, received supplemental FDA approval for its tablet formulation in December 2025.

Ozempic tablets and Wegovy tablets are available in the same strengths (1.5 mg, 4 mg and 9 mg, with one additional 25 mg strength cleared for Wegovy) and are taken daily.

Reuters: Novo Launches Ozempic Tablets in Second Quarter 2026
FDA: Safety Label Update for Rybelsus

New Cholesterol Drug Fast Tracked for Review

Patients may soon have a pill option for a PCSK9-inhibitor LDL cholesterol-lowering drug. Right now, only “large molecule” PCSK9-inhibitor injectables like Repatha or Praluent are available in this treatment category. The FDA granted Merck a “national priority voucher” for a faster review time of its enlicitide decanoate tablets. If approved, it will be the first oral inhibitor of PCSK9, the protein that limits the liver’s ability to remove bad cholesterol from the blood. Merck also received a priority voucher for its investigational lung cancer drug Sacituzumab Tirumotecan to treat advanced non-small cell lung cancer NSCLC with specific mutations.
FDA Announcement

Pharmacy Times: “FDA Grants National Priority Vouchers to Enlicitide Decanoate, Sacituzumab Tirumotecan

Eye Drops for Age-Related Blurry Vision (Presbyopia) Provides Alternative to Reading Glasses

Visus Therapeutic’s Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) received FDA approval to treat presbyopia, or age-related farsightedness causing blurry close-up vision in adults. The eye drops are administered once daily, one drop per eye, with effects lasting up to eight hours. Contact lenses can be inserted after using the eye drops, allowing correction of both distance and close-up vision without the need for glasses.

Like previously approved drops for presbyopia, Vizz (approved in 2025) and Vuity and Qlosi (approved in 2022 and 2024), the drops work by constricting the pupils (the pinhole effect) and holding them that way for hours. However, this can cause safety concerns when driving at night or doing other activities in dim light, and patients are warned to use caution when operating machinery or driving in dim light.
FDA: Yuvezzi Drug Label
ZME Science: Finally, a Daily Eye Drop That Could Actually Replace Your Reading Glasses

At-Home Brain Stimulation Treatment Approved For Depression

Swedish company Flow Neuroscience received FDA approval for a device that uses transcranial direct current stimulation (tDCS) to relieve depression by delivering electrical current through a headband to stimulate mood-regulating brain regions. Unlike transcranial magnetic stimulation (TMS), which require different equipment and office-based visits, tDCS can be self-administered with app-based guidance and remote monitoring.

The supporting trial, led by researchers at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London and published in Nature, showed that 58% of patients achieved remission from depressive symptoms after 10 weeks while just 29% of placebo patients achieved remission. Like many trials supporting drug approvals, quality long term data on effectiveness is lacking. Scientific American reported that a study published in the Lancet in 2023 found tDCS to be no better than a placebo for treating depression.

Forbes reports that while traditional office-based TMS is covered by commercial insurance and Medicare, tDCS, while much cheaper (expected to cost about $500-$800), has not yet been approved for reimbursement.

Forbes: FDA approves first at-home brain stimulation device for depression
Nature: “Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial
On its U.S. web site, Flow Neuroscience says it expects the devices to be available in the U.S. in summer 2026.
Also see: Brainsway TMS Device Approved to Treat Adolescents Age 15-21

Osteoporosis Drug Safety

The condition of osteoporosis is diagnosed based on the results of a bone density scan, a low-dose x-ray which measures calcium and other minerals in the bones. If the results indicate a person has low bone density or osteoporosis, deciding on treatment options can be complicated. Most prescription treatment options come with risks of serious side effects. On the Ask a Patient website, some patients have reported debilitating side effects from “bisphosphonate” drugs like alendronate (Fosamax brand name) including severe jaw pain, loss of bone in the jaw (osteonecrosis), stress fractures, and more.

If you are about to start a new osteoporosis drug or want to learn more about treatments, check out MedShadow’s recent article, “The Complicated Reality of Treating Osteoporosis,” a comprehensive guide to bone density and osteoporosis-related conditions, the types of treatments (including non-drug approaches), and safety concerns.

The FDA recently posted safety-related labeling updates for six osteoporosis “bisphosphonate” treatments. The labels now warn of the risk of atypical fractures (those that occur with minimal or no trauma to the affected bone) that occur not just in the femur but in other bones in the body. “Prodromal” pain in the affected area, usually presenting as dull, aching pain, occurs weeks to months before a complete fracture occurs. Safety updates are added for: Actonel, Atelvia, Binosto, Fosamax, Fosamax Plus D, and Reclast.

Links to patient reviews at Ask a Patient: Bisphosphonates Drugs
Read more about bone density scans at Medline Plus

Public Citizen Petitions FDA to Add Pregnancy Warnings on Antidepressant Labels

Many in the medical community, including the American College of Obstetricians and Gynecologists (ACOG), issued statements of alarm in reaction to the July 2025 FDA committee meeting convened to consider strengthening or adding warnings about the use of antidepressants SSRIs (Selective Serotonin Reuptake Inhibitors like Celexa and Prozac) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) like Effexor and Pristiq) during pregnancy. ACOG maintains that SSRI antidepressants are safe, necessary, and even lifesaving during pregnancy for many women with depression.

So far, the FDA has not requested any related changes to the drug labels. But consumer advocacy group Public Citizen recently filed a petition with the FDA urging the agency to require balanced, evidence-based pregnancy warnings in the product labels of serotonin reuptake inhibitor (SRI) antidepressants, which include SSRIs and SNRIs. In their letter, they cite research evidence of postnatal withdrawal symptoms (PNAS) in newborns who are exposed to SRIs in the third trimester of pregnancy.

“PNAS manifests as a constellation of variable transient cardiovascular, respiratory, central nervous system, gastrointestinal or motor adverse reactions. Specific signs include breathing problems, feeding difficulty, vomiting, low blood sugar levels, irritability, constant crying, temperature instability or seizures.”

The petition also requests adding a new warning about avoiding concomitant use of SRIs with benzodiazepines (sedative drugs like diazepam) or other central nervous system depressants in the third trimester of pregnancy because it can exacerbate PNAS in newborns.
Worst Pills, Best Pills February 2026 Newsletter: “Public Citizen Petitions FDA To Improve Pregnancy Warnings for Common Antidepressants” (Article is paywalled; abstract is available)

Public Citizen Press Release: Public-citizen-petitions-the-fda-to-require-updated-pregnancy-warnings-for-serotonin-reuptake-inhibitors

Pet Medication News

Check out our special post on pet medications news, featuring a new drug approval for idiopathic epilepsy in dogs, a new treatment for a type of cancer in dogs, a warning about a human drug that is toxic to pets, and an investigational medication that aims to extend the lifespan of dogs.

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More than 60 opioid-containing medications have new safety warnings that were posted on the FDA website last week, and additional products are expected to be updated in the coming days.

In July 2025, the FDA ordered major safety updates to the labels for all opioid medications, including Schedule II pain relievers like Demerol, Fentanyl, OxyContin, MS Contin, and Nucynta, as well as several medications used to treat substance addiction like Suboxone, Subutex, Zubsolv, Naltrexone, and Vivitrol.

The updated labels give clearer warnings about serious long‑term risks, including a newly highlighted problem called “opioid‑induced esophageal dysfunction” (OIED), or a problem with swallowing and heartburn symptoms. Labels now also include information from new clinical trials, warn about drug interactions with gabapentin and other medications that affect the central nervous system, and advise healthcare providers to share information about the availability of overdose reversal agents like naloxone (Narcan).

Examples of updated labels: hydromorphone hydrochloride, demerol, fentanyl citrate, morphine sulfate, oxycontin, suboxone Find the complete list in the FDA Safety-Related Label Changes Database received December 22, 2025 and posted between January 5 -8, 2026.

SpecGx Oxycodone Recall

SpecGx (a division of Mallinckrodt) is recalling more than 350,000 bottles of opioid pain drug oxycodone-acetaminophen combination tablets due to a manufacturing defect. The imprint information that identifies a pill’s strength and type, which should always be stamped on the side of a tablet, may be missing or only partially visible. The recall affects tablets with 10 mg or 7.5 mg of oxycodone and 325 mg of acetaminophen with these lot numbers: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027; 0522J23493, expires: 03/2027. The recall is directed at retail pharmacies.
FDA Recall announcement

MediNatura Homeopathic Nasal Spray Recall Expands

Medinatura expanded its December 10 recall to include ALL Reboost brand homeopathic nasal spray products along with all Clearlife Allergy nasal spray products due to yeast/mold and microbial contamination. Both products are in 20 ml bottles. ReBoost and ClearLife were distributed nationwide via retail and internet sales(medinatura.com). As of January 10, these products are still available for sale at some online retailers. Customers should immediately discontinue using the nasal sprays.

Customers who purchased the product directly from MediNatura New Mexico, Inc. should contact MediNatura New Mexico to arrange for a refund. Consumers who purchased the product at other retailers should return it to the place of purchase.
FDA Recall Announcement

Wegovy Recall

Novo Nordisk is recalling four lots of weight loss drug Wegovy (semaglutide) injection pens because hair was found in a prefilled syringe. These were manufactured at Novo Nordisk’s Bagsvaerd, Denmark, facility. Lot numbers include RZFYK06, RZFYA53 (.5 mg with expiration of 3/2027); RZFHD52, RZFHW93 (1 mg with expiration of 10/31/2026).
FDA Wegovy Recall

Rosuvastatin Recall

AvKARE announced that 7,991 cartons of 10 mg rosuvastatin tablets, packaged in 50-tablet blister packs, are being recalled because of failed dissolution specifications, meaning they don’t dissolve as expected. The lot number is Lot #49124, with an expiration date of 12/31/2026. Rosuvastatin is a widely used cholesterol-lowering medication. This recall is directed at suppliers.
FDA Rosuvastatin Recall

Depo-Provera (medroxyprogesterone acetate) Depo-Subq Provera: Warning about Meningiomas

Pfizer updated contraceptive Depo-Provera and Depo-Subq Provera labels to warn that cases of meningiomas (a type of brain tumor that is slow growing and is usually benign) have been reported, primarily with long-term use. Patients should be monitored for signs and symptoms of meningioma. Depo-Provera (injected intramuscularly) was approved in 1992 and the subcutaneous version was approved in 2004. Both formulations are taken every three months (13 weeks).

These medications are not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. However, many patients on the AskaPatient site report having taken it for well over 10 years and some report taking it for as long as 20 years.

A year ago, in January 2025, we reported that research has shown links between the injectable contraceptive Depo-Provera injections and an increased risk of developing meningiomas, which are usually benign brain tumors. The European Medicines Agency also required updates to labels.

Meningioma is the top reported adverse event for Depo-Provera with 1,306 cases reported (out of 13,287) in the FDA Adverse Events Database as of September 30, 2025.
Depo-Provera FDA Safety Label Update

Drug for Female Low Libido, Addyi, Expanded Approval for Postmenopausal Women

The FDA expanded its approval of Sprout Pharmaceutical’s Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under the age of 65. It was originally approved in 2015 for the treatment of HSDD in premenopausal women only. The label was updated with safety information from the clinical trials for postmenopausal women. Adverse reactions identified since its approval were added to the label: vomiting, asthenia (weakness), feeling abnormal, feeling drunk, malaise headache, faintness, gait disturbance, blurry vision, brain fog.
Addyi FDA Safety Update

Addyi has faced scrutiny over its safety and effectiveness. It has a long list of potential alcohol and drug interactions that may increase the risk of adverse reactions, including dizziness, low blood pressure, and drowsiness or sedation. Read more at
PharmedOut: “Is low libido a disease?” and MedShadow: “What Is Addyi? The Controversy Behind the Drug Nicknamed the ‘Female Viagra’”

Research: Stopping GLP-1 Weight Loss Drugs Leads to Faster Weight Regain than Discontinuing Behavioral Weight Loss Program

Researchers at Oxford University reviewed 37 studies tracking more than 9,000 adults who stopped taking weight management medicines after being on them for an average of 39 weeks of treatment. Participants were followed for an average of 32 weeks after stopping. The analysis included older weight loss meds like orlistat (Xenical or Alli) and newer GLP-1 receptor agonists like semaglutide (Ozempic or Wegovy) and tirzepatide (Mounjaro or Zepbound).

Weight regain after stopping drugs happened more quickly (within 1.4 years) than after ending behavioral weight loss programs such as diet and exercise support. The authors suggest that even after a formal behavioral weight loss program ends, “the experience provides people with practical coping skills that they can continue to implement past the end of the intervention to help with weight loss maintenance.”

In the chart below, “all drugs” (solid green line) include semaglutide, tirzepatide, liraglutide, exenatide, cagrilintide, orlistat, phentermine+topiramate, lorcaserin, naltrexone+bupropion, sibutramine, rimonabant, phentermine, topiramate, benzphetamine, diethylpropion hydrochloride, phendimetrazine, fenfluramine, and dexfenfluramine.
“Newer incretin mimetics” include GLP-1s semaglutide and tirzepatide. The pink solid line indicates a non-drug weight loss intervention program.

Journal Article: The BMJ
Oxford University Press Release: “Weight Gain After Stopping Weight Loss Drugs Review”

New Warnings for Rheumatoid Arthritis, Plaque Psoriasis, and Thyroid Eye Disease (TED) Treatments

Learn about the new safety information recently added to the drug labels for Actemra, Gazvya, Kineret, Rystiggo, Stelara, and Tepezza.
MedShadow: New Side Effects for Autoimmune Drugs

Drug Research: New Hair Loss Treatment May be Safer and More Effective than Finasteride or Minoxidil

An acne treatment ingredient is being studied as a treatment for male pattern baldness. Cosmo Pharmaceuticals says results from two trials suggest its topical treatment clascoterone 5% solution could become a game-changing treatment for male-pattern hair loss. The studies included 1,465 participants with male androgenetic alopecia (AGA) in 50 sites across Europe and the U.S. One trial showed a 539% relative improvement in target-area hair count (TAHC) through six months, while the other trial showed a 168% gain versus placebo. The difference in the trial figures is driven “entirely by baseline hair counts, not by a difference in drug performance,” said Cosmo CEO Giovanni Di Napoli.

Clascoterone 1% cream (brand name Winlevi) was approved in 2020 as a treatment for acne in patients age 12 and up. As a hair loss treatment, the topical androgen receptor inhibitor works by blocking dihydrotestosterone (DHT) directly at the hair-follicle receptor without systemic absorption, targeting the root cause of male-pattern hair loss without the risks of oral therapies. According to Cosmo, of 166 million men in the U.S., 65 million have AGA, including 16 million who have been treated and 27 million who are seeking treatment.
Fierce Pharma: Cosmo Shares Zoom on Results for Male Pattern Baldness Study

Andexxa Withdrawn from the Market

The FDA announced the withdrawal of Alexion’s Andexxa (Andexanet ALFA) from the market due to safety concerns. After being granted “accelerated” approval in 2018, continued approval was contingent on final clinical trials data and monitoring of adverse event reports. Andexxa was used as an antidote, on an emergency basis, to help curb severe bleeding in patients taking the blood thinner rivaroxaban (Xarelto) or apixaban (Eliquis). If a patient needs emergency surgery, with life-threatening or uncontrolled bleeding, an antidote is sometimes needed to help stop the bleeding. Unfortunately, unfavorable postmarketing safety data on thromboembolic events, including serious and fatal outcomes, have led the FDA to determine that the risks of Andexxa outweigh its benefits.
FDA Safety Communication: “Update on the Safety of Andexxa”

What will doctors now use to treat uncontrolled bleeding emergencies in patients taking oral blood thinners? Another medication, Praxbind, is approved as antidote for uncontrolled bleeding in patients taking the blood thinner Pradaxa. Unfortunately, like Andexxa, Praxbind also comes with a risk of thromboembolic events (like stroke), and it can only be used as an antidote for Pradaxa. Patients taking warfarin as a blood thinner are often given Vitamin K as an antidote. For Xarelto and Eliquis patients, there are some off-label or older I.V. options left.

Medication Tips: Blood Thinners

Check out the People’s Pharmacy’s advice about the bleeding risks associated with oral anticoagulants (oral blood thinners like Eliquis, Xarelto, and Pradaxa):

“Patients Walk a Dangerous Tightrope on Blood Thinners”

Read or add patient experiences for Coumadin, Warfarin, Xarelto, Eliquis, Lovenox, or Pradaxa blood thinners/oral anticoagulants at our website.

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Vist Ask a Patient Website

Thank you for reading this edition of Ask a Patient® Health News: Drugs & Treatments! Visit our website for more information about medications, including patient reviews and ratings for prescription drugs, along with patient experiences with common vaccines and some alternative treatments.

Genentech’s rheumatoid arthritis drug Actemra (tocilizumab) will soon have a new warning about the rare risk of hypofibrinogenemia, or low levels of the protein fibrinogen in the blood. Produced by the liver, fibrinogen helps blood to clot. Actemra is also associated with another serious drug-induced blood-related side effect: neutropenia, or a low number of white blood cells. Neutropenia makes it harder for the body to fight off infection. Actemra was approved in 2010.
The new warning was revealed in a letter from FDA to Genentech with an action date of December 10, 2025.

Read or add patient experiences with Actemra (current rating: 2.8, somewhat satisfied on average among 64 patients)

New Warning: Human Growth Hormone Drugs and Bone Problems

Growth hormone deficiency drugs have a new warning about the risk of slipped capital femoral epiphysis, which is a separation of the ball of the hip joint from the thigh bone at the upper (growing end) of the bone, which may lead to osteonecrosis (bone disease) in pediatric patients. Cases of slipped capital femoral epiphysis, with or without osteonecrosis, have been reported in pediatric patients with short stature receiving somatropin. Links to the label changes:
GENOTROPIN
HUMATROPE
NORDITROPIN
NUTROPIN AQ
OMNITROPE

Read more about slipped capital femoral epiphysis at Medline Plus.

Duchenne’s Elevidys: New Boxed Warning for Liver Injury; Revised Patient Eligibility

Sarepta Therapeutics’ Duchenne’s muscular dystrophy (DMD) treatment Elevidys has a new boxed warning and revised usage indications. The drug is now limited for use only by ambulatory patients (those who can walk) who are 4 years of age or older with the DMD gene. Earlier this year, two deaths occurred in non-ambulatory patients due to liver failure that occurred within two months of receiving the infusion treatment. For a short period, treatment was suspended while the company and the FDA investigated safety concerns.

The new boxed warning describes the risk of serious liver injury and acute liver failure, including fatal outcomes. Elevidys is one of just 48 approved gene therapy products in the U.S. and was originally approved in 2023.
FDA Safety Communication: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients

FDA Press Release: FDA Approves New Safety Warning and Revised Indication Limits for Elevidys

So far, about 200 adverse event reports have been sent by Sarepta Therapeutics to the FDA Adverse Events Reporting System (FAERS) between 2023 and 2025. The Elevydis FAERS Report Summary at Ask a Patient for reveals reported liver-related reactions include increased blood bilirubin levels, increased liver enzyme levels (including alanine aminotransferase), and 14 reports of “liver damage.” Only seven reports (3 by healthcare professionals, 1 by a consumer, and 2 by a pharmacist) have been filed directly with the FDA using its voluntary MedWatch Reporting System. Liver-related adverse effects also dominate the Elevydis MedWatch Direct Reports Summary.

Drug Recalls Roundup

Check our website for summaries of recalls for the generic Cymbalta antidepressant duloxetine, beta blocker bisoprolol, and generic testosterone gel.

Companies selling illegal injectable “Botox” types of products for cosmetic and medical use have been ordered by the FDA to remove the products from their websites. Find a the list of websites selling them at MedShadow Foundation: “Serious Risks of Unapproved Botox Injectables”

ReBoost Nasal Spray Recall

The FDA announced an urgent nationwide recall of MediNatura New Mexico Inc.’s ReBoost Nasal spray due to yeast/mold and microbial contamination, with one species identified as Achromobacter. The homeopathic nasal spray is used to temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose, and nasal itching. ReBoost is sold on many online retailer websites. The product (0.68 fluid oz bottle) was manufactured in Albuquerque, New Mexico, with an expiration date of 12/2027 and product lot number 224268, affecting about 37,000 bottles.

MediNatura has so far not received any reports of adverse events related to this recall, but the FDA says that “there is a reasonable probability that adverse health consequences including life-threatening infections will occur with use of the product in the immuno-compromised population.”
FDA Safety Announcement: MediNatura Recall of ReBoost Nasal Spray

Albuquerque TV station KRQE: “Company spokesman shares info on recall of Albuquerque-manufactured nasal sprays”

FDA warns that homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. In June 2025, Zicam cold remedy homeopathic nasal swabs and related products were recalled because of potential microbial contamination.
FDA article: “Some Homeopathic Products May Put You at Risk”

Medication Tip: Saline Nasal Spray to help prevent or treat respiratory illnesses

The homeopathic nasal spray under recall, ReBoost, has a long list of ingredients on its package:

Silver nitrate, euphorbia resinifera resin, calcium sulfide, goldenseal, potassium dichromate,luffa operculata fruit, sodium carbonate, echinacea unspecified, cairina moschata heart/liver autolysate and pulsatilla vulgaris.

While silver nitrate and potassium dichromate can serve as preservatives, testing of the product revealed microbial contamination. Dr. Ryan McCormick, writer of “Examined,” notes that our nasal passages are “ground zero” for respiratory illness, and recently wrote about why he thinks a simple nasal saline irrigation is beneficial and underutilized, and provides some relevant studies that support its use.

He says that “The Immune Defence trial, published in The Lancet, followed 14,000 adults over six months. Those using isotonic saline spray at the first sign of symptoms or after potential exposure experienced 20 percent fewer total illness days compared to usual care - about 18 versus 22 days over the study period. Notably, participants only used sprays reactively when they felt symptoms starting, not as daily prevention.”

McCormick notes that many people don’t like “neti pots,” (full nasal irrigation), but saline sprays can also be beneficial.

Examined: “The 5,000-year-old hack that could cut your sick days by 20% - or prevent some illnesses entirely.”

Check Medline Plus for instructions on making a nasal saline wash and explanation of how saline nasal washes or sprays can help relieve nasal allergy symptoms and help prevent sinus infections (sinusitis). Make sure to use distilled or boiled water if you are making your own solution.

Two newsletters were sent today. In addition to this Drug Safety Update, find the newsletter featuring New Drug Approvals here:
December 2025 New Drug Approvals

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Note to Readers: The newsletter will be on Holiday Break until the new year. However, we may post occasionally in the “Notes” section of the newsletter website news.askapatient.com.

Visit our main website with a drug database of patient experiences at www.askapatient.com

Wishing all of our readers a Happy and Healthy Holiday!

Huge Duloxetine Recall by Breckenridge

A huge recall is underway for a Cymbalta generic: Breckenridge’s Duloxetine Delayed-Release Capsules, 60 mg strength. More than 170,000 bottles are being recalled due to nitrosamine impurities (a potential cancer risk) above FDA limits. Cymbalta is an antidepressant and anxiety treatment.
FDA Recall Announcement

Clomipramine Hydrochloride by Northstar

Three different strengths (25mg, 50mg, and 75mg) of Clomipramine Hydrochloride capsules, generic for Anafril, are under recall by Northstar because of nitrosamine impurities (a potential cancer risk) above FDA limits. These pills were manufactured by: Zydus Lifesciences Ltd. Quantity is not provided, but check the announcement for lot numbers. Anafril is classified as a “tricyclic” antidepressant, approved in 1989, but is most often used to treat OCD (obsessive compulsive disorder).
FDA Recall Announcement

Bupropion Recall by Graviti Pharmaceutical

Graviti Pharmaceutical’s Bupropion Hydrochloride Extended-Release Tablets XL (Zyban generic) are under recall for quality control failures. The recall affects 46,512 bottles of 300 mg strength (30-count), distributed and packaged by Rising Pharma. The label features the “Rising Pharma” logo. Zyban (now only available as generic) is a treatment for patients who are trying to quit smoking.
FDA Recall Announcement

Additional Recalls

Check out these additional recall summaries posted at our website: Parkinsons: Carbidopa/Levodopa/Entacapone (by Rising Pharma); Schizophrenia/bipolar: Chlorpromzine (by Major Pharmaceuticals); Cholesterol lowering: Niacin extended release (46,848 bottles by Lanett) and pain reliever Tylenol (500 mg caplets by Kenvue Brands).

Bupropion-Containing Drugs: Risk of Drug-Induced Meningitis

Bupropion-containing drugs have new warnings about the risk of a condition called “aseptic meningitis”, or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord, and is usually caused by a virus or bacteria. Aseptic meningitis is not caused by bacteria but could be caused by a drug or virus. Symptoms may include headache, stiff neck, or sensitivity to light.

Read about the different kinds of meningitis at Cleveland Clinic: Meningitis: Causes, Symptoms, Treatment

These bupropion-containing drugs contain the new warnings:

Aplenzin (bupropion hydrobromide) extended release tablets

In addition to the new warning about aseptic meningitis, Aplenzin’s drug label has a new warning about a severe skin hypersensitivity reaction called eosinophilia and systemic symptoms (DRESS). Aplenzin is approved to treat major depression as well as seasonal affective disorder (SAD).
Aplenzin Safety Label Change

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended release tablets

Approved in 2022, Auvelity treats major depression in adults. The revised label includes the new warning about aseptic meningitis.
Auvelity Safety Label Change

Contrave (naltrexone and bupropion)

Label was updated with the warning about aseptic meningitis along with the risk of severe skin reaction called Acute generalized exanthematous pustulosis (AGEP). Contrave is approved as a weight loss treatment in adults with at least one weight-related comorbid condition, such as hypertension or high cholesterol. It is a combination of bupropion hydrochloride (used in antidepressants) and naltrexone hydrochloride (most often used as an alcohol or opioid addiction treatment). Contrave was approved in 2014.
Contrave Safety Label Change

Additional Bupropion-Containing Medications with Updates

All of the following medications are antidepressant treatments:
Forfivo XL Safety Label Update
WELLBUTRIN Safety Label Update,
WELLBUTRIN SR Safety Label Update
WELLBUTRIN XL Safety Label Update

Depression Treatments Approvals

TMS Device by Brainsway

Brainsway received approval for its Transcranial Magnetic Stimulation (TMS) device to treat major depressive disorder (MDD) in adolescents age 15 – 21.
Psychiatric Times: “FDA Clears Deep Transcranial Magnetic Stimulation for Adolescents With MDD”

Psychology Today explains why TMS treatments have been slow to catch on - and why the public has instead been captivated by psychedelic treatments like ketamine: “There is a natural tendency to compare TMS with electroconvulsive therapy (ECT), which may be a deterrent. ECT, unlike TMS, is not targeted, using direct electrical current to “reset” the brain by inducing a generalized seizure. ECT is highly effective, the gold standard around 80% and well-tolerated, but requires sedation, anesthesia, and recovery.”

Psychology Today: Could Acclerated TMS for Depression Become Standard? Emerging treatment protocols offer guidance to safely expand TMS use.

Caplyta (lumateperone ) Capsules: Newly Approved for Major Depressive Disorder

J&J’s Caplyta recently received expanded FDA approval as a treatment for major depression in adults, to be used along with an antidepressant. Adults who don’t respond to an antidepressant alone may be prescribed this antipsychotic as an adjunctive treatment.
Caplyta Drug Label Safety Update

Patient Opinions about Caplyta on Ask a Patient

In this newsletter, an expanded FDA approval or revised drug safety information is described and includes a link to the associated drug label change. Today, we’re taking a closer look at a drug label change to show how risk information might be edited or removed in a revision, sometimes without an explanation as to why the changes are being made. In the case of Caplyta, it is notable that the Tardive Dyskinesia Warning Section was significantly reduced. If you’d like to learn more, check out:
Special Feature: Caplyta (lumateperone ) Capsules: How a New Approval Can Change a Drug Label in Unexpected Ways
(The article will be posted by November 17.)

Recommended Podcast: “Why is the FDA Planning to Ban Natural Desiccated Thyroid?”

After a recent FDA announcement, many patients are concerned they will lose access to NDTs, or natural desiccated thyroid, a type of medication used for hypothyroidism. The FDA says that concentrations of active ingredient in the natural products are not consistent and the source materials (dried or “natural desiccated” thyroid gland, usually from a pig) may have impurities. Examples of these products include Armour Thyroid, NP Thyroid, Nature Thyroid, and more. Recently, the FDA alerted makers of these products that patients will need to transition to FDA-approved synthetic versions (such as levothyroxine) by August 2026. However, more than 1.5 million patients rely on the natural treatments (which have been used for more than 100 years) because they don’t respond to the synthetic treatment..

Terry and Joe Graedon of the People’s Pharmacy interviewed endocrinologist Antonio Bianco and author and patient advocate Mary Shoman, who explain why some people don’t respond to the synthetic treatments. They also speculate on chances that the meds will gain swift approval without resulting in price hikes.

Check out patient opinions about Armour Thyroid at Ask a Patient

Link to Podcast (from November 15) at People’s Pharmacy or on Apple Podcast

No doubt about it, GLP-1 drugs like semaglutide and tirzepatide can help you lose weight by mimicking natural hormones that slow digestion and help you feel full for long periods of time. But three new Cochrane reviews on the effects of these drugs on adults with obesity raise concerns about long-term outcomes, side effects, and conflicts of interest from industry-funded studies. Semaglutide (18 studies), tirzepatide (9 studies), and liraglutide (24 studies) were separately examined. The reviews were commissioned by the World Health Organization as part of its efforts to provide guidelines for the use of GLP-1 medications.
Cochrane Review: “GLP-1 drugs effective for weight loss, but more independent studies needed”

Recall of Compounded GLP-1s

ProRx, of Exton, Pennsylvania, is recalling more than 36,000 multidose 1 to 5 mL vials of compounded semaglutide of various strengths that were distributed in Texas and Utah. In addition, it is recalling 2,761 3 mL vials of compounded tirzepatide. The reason for the recall is a lack of assurance of sterility. The recall is directed at suppliers, but consumers may wish to check the recall link for affected lot numbers. Earlier this year, ProRx received a warning letter from the FDA after a facility inspection and in 2024, ProRx recalled 15,000 vials of semaglutide.
FDA Recall Announcement
MedShadow Foundation: More about Compounded GLP-1 Recalls and Compounding Pharmacies Safety and Misleading Marketing of Compounded GLP-1s

Levothyroxine Sodium Tablets (Synthroid generic) Recall by Accord Healthcare

Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets, 88 mcg (90-count bottles), due to subpotency (less than the required amount of active ingredient) discovered during long-term stability testing. The tablets were manufactured by Intas Pharmaceuticals Limited in Selaqui, India. Levothyroxine is generic for Synthroid and treats hypothyroidism. The recall is directed at suppliers, but consumers may wish to check the recall link for affected lot numbers.
FDA Recall Announcement

Prazosin (Minipress generic) Recall by Teva

Teva Pharmaceuticals USA is recalling over 580,000 bottles of blood pressure drug Prazosin Hydrochloride capsules in 1 mg, 2 mg, and 5 mg strengths. Testing revealed levels of nitrosamine, a carcinogenic impurity, above the FDA-allowed limits. Prazosin is generic for hypertension drug Minipress, and is also used off-label to treat symptoms of post-traumatic stress disorder, including nightmares and sleep disturbances. The recall is directed at suppliers, but consumers may wish to check the recall link for affected lot numbers.
FDA Recall Announcement
Related recall of Prazosin: American Health Packaging Recall
More about nitrosamine from FDA: Information about Nitrosamine Impurities in Medications

Check our website for briefs on additional recent recalls of Atorvastatin, Fasenra, and Gabapentin, and more.

Carvykti Boxed Warning Update

Janssen’s T-cell therapy for multiple myeloma (a type of blood cancer), Carvykti (ciltacabtagene autoleucel injection, suspension for intravenous administration) had its Boxed Warning updated to warn of the risk of a life-threatening condition called immune effector cell-associated enterocolitis (IEC-EC). Cases of IEC-EC have been reported since the drug was approved in 2022.

Patients with IEC-EC have symptoms including severe or prolonged diarrhea, abdominal pain, and weight loss requiring total parenteral (feeding tube) nutrition and treatment with various immunosuppressive therapies, including corticosteroids. In reports, IEC-EC occurred weeks to months following infusion.

In spite of the newly identified risks, the FDA has determined that the overall benefit of Carvykti continues to outweigh the potential risks for approved use, including overall survival benefit in patients treated with Carvykti. Each dose is customized using a patient’s own T-cells, which are collected, genetically modified, and then infused back into the patient.
FDA Announcement on Carvykti
Oncology Nursing Society: ONC Voice: FDA Approves Boxed Warning

Kineret (Anakinra) and Injection Site Reactions

Rheumatoid arthritis (RA) drug Kineret (Anakinra) had a label update to warn that cases of injection site amyloid deposits (build-up of abnormal proteins) have been reported in patients after receiving high doses of Kineret injected subcutaneously into the same area of skin over long periods of time. Patients are advised to rotate the injection site and to avoid injecting into an area that is already swollen or red. Patients with confirmed injection site amyloid deposits should be monitored for systemic amyloidosis; this happens when the protein deposits happen throughout the body’s organs and tissues. Kineret was approved in 2001.
Kineret Safety Label Update

Read more about amyloidosis at MedLine Plus or Cleveland Clinic.
Read Patient Experiences with Kineret and check out our new MedWatch Safety Summary for Kineret derived from adverse event reports submitted directly to the FDA by patients, physicians, and other health professionals.

Lamictal (lamotrigine) and Serious Skin Rashes

Lamictal’s boxed warning was updated to warn that people of certain Asian ancestry with the HLA-B*1502 allele have a genetic propensity for an increased risk of life-threatening skin rash, including Stevens Johnson Syndrome. Other factors also increase the risk of serious skin hypersensitivity reactions, but cases have occurred in the absence of these factors. Lamictal treats epilepsy and bipolar disorder. It was approved in 1994.
Lamictal Safety Label Update

MIEBO (perfluorohexyloctane) Eye Drops Safety

Dry eye treatment MIEBO (perfluorohexyloctane ophthalmic solution) had its label updated to warn of hypersensitivity reactions that were reported in pre-marketing clinical trials. Those with hypersensitivity to perfluorohexyloctane should avoid using Miebo. Miebo eye drops are applied four times a day. The drug was approved in 2023.
Miebo Safety Label Update

Related News about Miebo: Stat reports that Bausch & Lomb’s Miebo, which sells for $800 a month (before insurance) in the U.S., has been sold over-the-counter as EvoTears in Europe since 2015 and costs only about $20. Reporter David Maris observes that “finding a way to get an existing European OTC drug to be a prescription drug in the U.S. with a new name and a 40-fold price increase is not true innovation — it’s a price-gouging strategy.”
Stat: “A $20 over-the-counter drug in Europe requires a prescription and $800 in the U.S.”

Do these eye drops work for you? Worth the cost? Please take a few seconds to rate it at Ask a Patient using this form: Add a rating for Miebo

So far, 48 MedWatch reports have been filed since it was approved in late 2023, with 40 of the reports submitted by women.

Tezspire Subcutaneous Injection for Nasal Polyps: New Safety Information

In conjunction with its expanded approval as an add-on maintenance treatment for chronic sinus infection with nasal polyps for age 12 and up, AstraZeneca’s Tezspire (tezepelumab-ekko) had a safety label update to provide related clinical trials results and updated side effects information. Newly listed common side effects include: common cold symptoms, upper respiratory tract infections, nose bleeds, flu, and injection site reactions. Tezspire was approved in 2021 as an add-on maintenance treatment for severe asthma.
Tezspire Safety Label Update

Zoladex (goserelin implant) Subcutaneous Injection and Risk of Stevens Johnson Syndrome

Prostate and breast cancer drug Zoladex had a safety label update to warn of the risk of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis. Zoladex 3.6 mg is used to treat women diagnosed with breast cancer, endometriosis, and dysfunctional uterine bleeding, as well as to treat men with prostate cancer. Zoladex 10.8 mg is used to treat men with prostate cancer. Zoladex was approved in 1996.
Zoladex Safety Label Update
Read more about Stevens-Johnson syndrome at Medline Plus.
Read Patient Experiences with Zoladex

FDA Announces New Safety Warning for Radiofrequency (RF) Microneedling Devices

In a safety communication, the FDA warned about the risk of serious side effects from procedures using radiofrequency (RF) microneedling devices, which are marketed for facial wrinkles, abdominal scars, or acne scar improvement . The devices are often used at dermatology or med spa types of facilities. The FDA learned about device-linked injuries and side effects from reports it has received from patients and manufacturers and also from comments found on social media web sites.

RF microneedling devices have been linked to burns, hypersensitivity, scarring, fat loss, and nerve damage. FDA states that RF microneedling should only be performed by trained medical professionals, never at home. Patients considering such procedures should discuss potential risks and benefits with their doctor and make sure the provider has proper training and experience with using the device.

Patients experiencing complications should contact their healthcare provider and are also encouraged to report the problem to the FDA using the voluntary MedWatch reporting system.

FDA Safety Communication: “Potential Risks of Certain Uses of Radiofrequency RF Microneedling”

The FDA announcement may affect the consent obligations for providers of the treatments. This law firm, for example, recommends that facilities update their consent forms with the new risks.
Holt Law: FDA issues urgent warning on RF Microneedling New Risks; How to Protect Your MedSpas Liability

Some “microneedling” devices are NOT considered medical devices and are not regulated by the FDA and so don’t pose the risks described in the safety communication. These products don’t deeply penetrate the skin and instead help exfoliate the skin. Read this FDA guidance that explains the differences in microneedling devices and provides safety tips:
FDA: “Microneedling Devices: Getting to the Point on Benefits, Risks and Safety”

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Over 151,000 bottles of Apotex’s glaucoma treatment Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution were recalled due to improper bottle sealing and potential lack of sterility of the 5mL and 10mL eye drops bottles.

On the same announcement, Apotex is recalling 493,000 bottles of 5mL prescription-only allergy relief eye drops Ketorolac Tromethamine because of improper bottle sealing and potential lack of sterility. Ketorolac Tromethamine drops are generic for Allergan’s Acular brand name version.

Both of these recalls are classified as a level III recall, the lowest urgency type of recall. The FDA has determined that product use is not likely to cause adverse health consequences. Check the FDA announcement for specific lot numbers.
FDA Recall Announcement

Dextroamphetamine Saccharate (Adderall XR Generic) Recall by Granules Pharmaceuticals

Over 50,000 bottles of Attention-deficit/hyperactivity disorder (ADHD) treatment Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules have been recalled by Granules Pharmaceuticals because of an unknown impurity found in the product during a stability study.

This recall includes five separate lots of 100-count bottles with strengths ranging from 5 mg to 30 mg. Check the FDA announcement (Enforcement report) for the specific lot numbers. Adderall is used to treat ADHD. This recall is classified as a level II recall, the middle urgency type of recall because the probability of serious adverse health consequences is remote. This drug is generic for ADHD treatment Adderall XR.
FDA Recall Announcement

Lanett recently recalled its generic Adderall tablet version of the medication.

Read or add patient reviews for Adderall

Safety Update Planned for Acetaminophen

In a move that some medical groups do not agree with, the U.S. Food and Drug Administration has started the process for adding a warning to the labels of acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.

In the letter, FDA Commissioner Martin Makary stated that “while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.”

Makary also reminds clinicians that acetaminophen is the safest over-the-counter medication option in pregnancy among all analgesics and fever reducers and that aspirin and ibuprofen have well-documented adverse impacts on the fetus.

The FDA provides links to large-scale studies, including the Nurses’ Health Study II and the Boston Birth Cohort that have results that suggest concerns. Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy.

FDA Press Release

FDA to Study Potential Treatment for CFD-Related Autism

In line with its new commitment to finding the root causes of autism and treatments for it, the FDA is working with GSK, innovator of Wellcovorin (leucovorin calcium), to broaden the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain.

Individuals with cerebral folate deficiency may have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination. The FDA states that additional studies are needed to assess safety and efficacy before leucovorin calcium approval for this patient population.

FDA Press Release

Confusion about Folate Supplements and Leucovorin Calcium

Currently, leucovorin calcium is available as a generic only and is approved to relieve toxic effects of the cancer and rheumatoid arthritis (RA) drug methotrexate. Since the FDA’s announcement about its potential treatment for CFD, many people have been seeking over-the-counter versions of folate (Vitamin B9 or leucovorin) to help with autism symptoms. However, over-the-counter leucovorin is NOT the same drug as leucovorin calcium tablet, which is available by prescription only.

Washington Post: “Touted Treatment for Autism Sparks Interest in Over-the-Counter Alternatives”

Methotrexate patient reviews at Ask a Patient
Leucovorin calcium reviews

EMA Adds Warning about Eye Condition Causing Sudden Blindness to Ozempic and Wegovy Drug Labels

A rare but serious eye condition called non-arteritic anterior ischemic optic neuropathy (NAION) happens when blood flow to the optic nerve is blocked, causing sudden, painless loss of vision in one eye. It is a leading cause of vision loss in adults and the second most common optic neuropathy after glaucoma. The vision loss is generally irreversible, and there is currently no effective treatment available. In the past few years, there have been reports linking the condition to GLP-1 drugs like semaglutide and tirzepatide.

After a reviewing the evidence from non-clinical studies, clinical trials, and data from post-marketing surveillance, The European Medicines Agency (EMA) committee concluded that NAION is associated with use of semaglutide (the active ingredient in Ozempic and Wegovy). A required warning about the risk, which it classifies as very rare, affecting about 1 in 10,000 users, will appear on product labels for Ozempic and Wegovy.

In the European Union, patients are advised to immediately consult a doctor if they experience worsening eye sight or sudden loss of vision while using semaglutide and to discontinue use of semaglutide if they are diagnosed with NAION.
European Medicines Agency Press Release: “PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy”

The World Health Organization (WHO) also made an announcement about the risk of NAION associated with semaglutide. However, the EMA and WHO have not expanded the warning to include other GLP-1 diabetes and weight loss drugs such as tirzepatide-containing Mounjaro and Zepbound.
WHO Press Release: “The use of semaglutide medicines and risk of non-arteritic anterior ischemic optic neuropathy (NAION)”

The U.S. FDA has not yet announced any changes or potential changes to semaglutide labels related to NAION risk. According to the American Academy of Ophthalmology, U.S. ophthalmologists are NOT recommending discontinuation of GLP-1s for all patients who experience NAION, because of potential risk to some patients’ health. Instead, they are recommending a personalized decision making process.

In 2024 and 2025, an increasing number of cases of ischemic optic neuropathy have been reported through the FDA adverse events reporting system (FAERS) for semaglutide drugs. Although patients with ischemic optic neuropathy (a broader term than NAION) may not experience the sudden blindness effects, this seems to be the closest “term” that is used to describe the NAION side effect in the FDA database.

In 2025 so far, the FDA has received 379 reports of ischemic optic neuropathy associated with Ozempic, Wegovy, and semaglutide combined. This represents 1.55% of all 24,484 semaglutide cases filed so far this year. In 2024, 106 cases were reported, and only a few reports with this side effect were submitted prior to 2024. The only drug with more reports of ischemic optic neuropathy is erectile dysfunction drug Viagra, with 429 total cases for all time.

Data Source: FDA FIS Dashboard

Read more about ischemic optic neuropathy and NAION at Cleveland Clinic.

Recommended Podcasts and Videos

In a recent episode of Sensible Medicine’s “This Fortnight in Medicine,” doctors Adam Cifu and John Mandrola discuss and interpret the findings from a study that examined how GLP-1 receptors in the optic nerves are affected by the GLP-1 receptor agonist drugs semaglutide and tirzepatide. The study found a link, albeit rare, between optic nerve eye disease (including NAION) and semaglutide and tirzepatide.
“Do diabetes medications help arthritis or hurt the eyes?” Listen or watch the episode here:

Sensible Medicine

This Fortnight in Medicine VII

Metformin for Treatment of Knee Osteoarthritis in Patients With Overweight or Obesity…

Listen now

10 months ago · 31 likes · 4 comments · Adam Cifu, MD and John Mandrola

In the same program, the doctors give their opinion about a study suggesting that diabetes medicine metformin can help with osteoarthritis of the knee. Adam Cifu explains that he frequently prescribes metformin; in this episode he does a good job of describing, in layman’s terms, what metformin is.

First approved in Europe in the 1950s, metformin is emerging as a wonder drug (though not at the current level of GLP-1 excitement). Besides its use as a type 2 diabetes treatment, metformin has shown promise for treating Long Covid, improving longevity, lowering dementia risk for those with type 2, and as a treatment for kidney disease, lung conditions like COPD, and more.
UPI: “Metformin: Science finds new benefits from an old drug”

Interview with FDA Commissioner on Crackdown on Misleading Drug Ads and False Claims on Telehealth Websites

In a recent episode of investigative news program Full Measure, reporter Lisa Fletcher interviewed FDA Commissioner Marty Makary about new crackdowns on misleading drug ads and problematic telehealth websites like Hims and Hers. Also, Georgetown University’s Pharmed Out director Dr. Adriane Fugh-Berman explains how visuals in ads and cherry-picked safety disclosures are among the deceptive tactics that have been used for years to promote drugs directly to consumers. The segment is about five minutes long and aired on television September 28. Watch it here:
Full Measure: “Pharma Ads”

Note: It is now (on October 6) 4 business days beyond the 15-day deadline for pharmaceutical companies to respond to the warning letters sent by the FDA regarding misleading and distracting drug advertising. So far, most of the infringing television ads are still on the air, with no modifications or removals yet to address the FDA’s concerns. It could be that because of the government shut-down, pharma companies will gain some extra days to respond to the warnings.

Did you miss the last edition? Check it out here:

Ask a Patient® Health News: Drugs & Treatments

Nationwide Recalls for Cyclobenzaprine, Multiple Generics; Warnings for Briviact, Lupron Depot, Riluzole, Tepezza, Tiglutek; Pharma Ad Crackdown, More

Drug Recall: Cyclobenzaprine Hydrochloride…

Read more

10 months ago · 3 likes · Katie Rowley

Unichem is recalling one lot of 10 mg cyclobenzaprine hydrochloride tablets due to a labeling mix-up. 230 bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were inadvertently labeled as cyclobenzaprine hydrochloride tablets USP, 10 mg 90-count tablets (blue in color). This is a Class I recall, the most urgent kind of recall because of the potential danger to consumers.

The pills were manufactured by Unichem Laboratories in Bardez, Goa, India for Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. The lot number is GMML24026A with a product expiration of 09/30/2027. Cyclobenzaprine is a muscle relaxant and is also known by the brand name drugs Amrix and Flexeril. Meloxicam is a non-steroidal anti-inflammatory drug used to treat arthritis pain.
FDA Press Release and FDA Enforcement Report

Compounded Semaglutide and Tirzepatide Recalls

In August 2025, we reported on a recall of compounded semaglutide and tirzepatide (the active ingredients in Ozempic and Mounjaro). Now, three compounding pharmacies are recalling their semaglutide and tirzepatide drug products due to sterility or other quality problems. Separately, Tailstorm Health (Medivant) and ProRx GLP-1 compounding pharmacies received warning letters from the FDA after facility inspections revealed unsanitary conditions and concerns about manufacturing procedures. Find summaries of these recalls at MedShadow website:
FDA Recalls for Compounded GLP-1s

Recalls for Generics: Aripiprazole (Abilify) Bevacizumab (Avastin), Lisdexamfetamine (Vyvanse), Chlorpromazine, Sulfamethoxazole (Bactrim), Dextroamphetamine (Dexedrine), Entecavir

Find highlights of nationwide recalls for these generics at our website: Recent Drug Recalls: Aripiprazole, Bevacizumab, Cyclobenzaprine, Lisdexamfetamine, Chlorpromazine, Sulfamethoxazole, Dextroamphetamine, Entecavir

New Safety Warning for Briviact (brivaracetam) tablets, oral solution, and injection for intravenous use

Seizure and epilepsy drug Briviact (brivaracetam) has a new warning about the risk of severe skin reactions, including severe rash with blisters and peeling skin. Also, Stevens-Johnson syndrome (SJS) and its most serious variant, toxic epidermal necrolysis, has been reported, with a time to onset ranging from 3 to 45 days after starting the drug. Briviact should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. Briviact was approved in 2016.
Briviact FDA Safety Label Change
Read more about Stevens-Johnson syndrome at Medline Plus.

New Safety Warning for Lupron Depot (leuprolide acetate for depot suspension), for intramuscular injection (multiple strengths)

Lupron Depot has a new warning about the risk of serious skin reactions, including Severe Cutaneous Adverse Reactions (SCARs). These reactions include Stevens-Johnson syndrome and its most serious variant, toxic epidermal necrolysis, as well as drug reaction with eosinophilia and systemic symptoms (DRESS). This risk was first flagged for all versions of Lupron Depot by the FDA in 2023 and was included in its “watch” list based on reports received through the FDA Adverse Events Reporting System.

Lupron Depot was approved in 1985 and is a gonadotropin-releasing hormone (GnRH) agonist. It is approved in different strengths and dosing regimens and sometimes used in conjunction with other medications for a variety of conditions, including endometriosis, uterine fibroids, prostate cancer, precocious puberty in young children, and also is used “off-label” in gender-transitioning adolescents as hormone blockers, often in conjunction with gender-affirming hormones. Not all versions of the drug labels have been updated yet with the skin reaction warnings.
Lupron Depot FDA Safety Label Change (for endometriosis)
Lupron Depot FDA Safety Label Change (for prostate cancer)
Read more about Stevens-Johnson syndrome at Medline Plus.

New Safety Warning for Tepezza (Teprotumumab-trbw injection) for intravenous use

Thyroid eye disease (TED) drug Tepezza has a new warning about the risk of worsening or new-onset Inflammatory Bowel Disease (IBD). If IBD is suspected, patients should discontinue Tepezza. TED is a disorder in which the immune system causes inflammation and swelling behind the eye, and affects about 25 to 50 percent of patients with Graves disease. Graves disease is an autoimmune condition that leads to an overactive thyroid (hyperthyroidism). Tepezza was approved in 2020.
Tepezza FDA Safety Label Change

New Safety Warning for Tiglutek (riluzole) oral liquid and Rilutek (riluzole) tablets

Amyotrophic lateral sclerosis (ALS) drug Tiglutek (riluzole) oral liquid and riluzole tablets have a new warning about the risk of pancreatitis. Sudden onset of pancreatitis has occurred weeks to several years after initiation of riluzole. Patients and caregivers should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation Riluzole was approved in 1995 and the Tigultek formulation was approved to treat ALS in 2018. ALS is also known as Lou Gherig’s Disease.
Tiglutek FDA Safety Label Change
Rilutek FDA Safety Label Change
Read more about ALS at Medline Plus.

Young Children taking ADHD Drugs May Experience Weight Loss

The FDA is revising the labeling of all extended-release stimulants treating attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients younger than 6 years taking these medications. Extended-release stimulants are not approved for children younger than 6 years, health care professionals sometimes prescribe them "off label" to treat ADHD.

The FDA has found that children younger than 6 years old experience weight loss and other side effects at greater rates than older children taking the same medications at the same dosages. Clinically significant weight loss of at least a 10% decrease in the Centers for Disease Control and Prevention (CDC) weight percentile was observed in both short- and long-term studies with extended-release stimulants.
FDA Press Release

FDA Sends Warning Letters for Misleading Drug Advertising

In 2024, the FDA announced changes in drug advertising requirements, mandating consumer-friendly language, more disclosure of side effects with less distractions, and imposed an implementation deadline of November 2024. Since then, the ads didn’t seem to change. Now, the FDA is taking regulation a step further.

The FDA posted 40 letters sent to pharmaceutical companies that describe specific violations of the disclosure requirements. Misleading prescription drug advertising included television commercials, social media posts, and a television show about Ozempic featuring Oprah Winfrey that aired in 2024. Novo Nordisk, Pfizer, Takeda, Bristol-Myers Squibb, AbbVie, and Teva Neuroscience, are just some of the pharmaceutical companies that were sent letters.

While the FDA isn’t banning drug ads outright, it is paying closer attention to make sure companies clearly share safety information and provide a realistic idea of how well their medicines might work, which could mean some ads will have to be changed or even taken off the air. An example of a screenshot from an ad for Camzyos that was found to be in violation is shown below.

ABC News: “Trump signs memorandum pressuring pharma companies to abide by ad laws”
Regulatory Focus: “FDA posts more than 100 warning and untitled letters in ad crackdown”

Letters Sent from the Office of Prescription Drug Promotion may be sorted by date, company name or product name. Additional warning letters, with compliance information, were posted in the Warnings Letters database.

Webinar Recommendation

On September 24th at 4PM ET, MedShadow Foundation will host its second webinar on generic drug quality concerns: Mending the Tattered Safety Net of the FDA.

Program: “Mending the Tattered Safety Net of the FDA”
Host: Suzanne Robotti, Founder and President, MedShadow Foundation
Panelists: Peter Baker, a former F.D.A. inspector, Rosemary Gibson, health policy analyst and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine , and John Gray, investigative researcher from Ohio State University
When: Wednesday, September 25 at 4 pm Eastern Standard Time (sign up to receive access to the recording even if you can’t attend live)
Sign Up: https://medshadow.org/webinar-investigating-generic-drugs-mending-the-tattered-safety-net-of-the-fda/

Supplement Tip: Choosing a Probiotic

Dr. Lucy McBride, writer of “Are You Okay?” recently answered a question from a reader who hadn’t seen improvement from her symptoms after taking probiotics for three months. With so many options available, how do you know if you’re taking the right kind of probiotic?

Did you miss the last edition of the newsletter? Check it out here:

The next edition will include more drug safety news, drug approvals, and an update on GLP-1 eye-related side effects. Thank you for reading! Visit our website at www.askapatient.com for more on drug treatments.

Four multiple sclerosis (MS) drugs have new warnings about the risk of serious drug-induced liver injury. Prior to starting these therapies, patients must have liver function tests to assess liver enzymes and bilirubin levels. Signs of liver injury have occurred weeks to months after taking the drug. Symptoms that may indicate liver injury include new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes (jaundice).

All of the MS medications with the new warnings are a specific type of monoclonal antibody medication called “anti-CD20 monoclonal antibodies.” Patients taking these drugs are also screened for Hepatitis B before beginning treatment because the medications may trigger reactivation of the virus. The new warning about serious liver injury is not hepatitis-related. In published case studies, liver function improved and resolved after discontinuing the medication.

Ocrevus (ocrelizumab and hyaluronidase-ocsq) intravenous infusion

Ocrevus is administered by IV twice a year. It was approved in 2017.
Ocrevus Safety Label Change

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) subcutaneous injection

Ocrevus Zunovo is administered by subcutaneous injection twice a year. It was approved in 2024.
Ocrevus Zunovo Safety Label Change

Briumvi (ublituximab-xiiy) intravenous infusion

Briumvi is taken every 24 weeks after the first two doses, which are taken two weeks apart. It was approved in 2022.
Briumvi Safety Label Change

Kesimpta (ofatumumab) subcutaneous injection

Kesimpta is taken monthly after the first three doses, which are taken one week apart. Kesimpta was approved in 2009 under the name of Arzerra, an intravenous infusion formulation that treats leukemia. In 2020, Novartis received additional approval for Kesimpta, which uses the same ingredient in a subcutaneous formulation, for treating relapsing forms of multiple sclerosis (RMS).

Although Kesimpta (ofatumumab) has a new warning about liver injury, some studies have shown that the risk of liver injury is lower than with ocrelizumab.
Frontiers in Neurology: “Successful switch to ofatumumab after liver injury associated with ocrelizumab treatment in multiple sclerosis: a case report”

Kesimpta Safety Label Change

Xcopri (cenobamate) Tablets and Liver Injury

Epilepsy drug Xcopri has a new warning about reports of clinically significant liver injury. Prior to starting the medication, patients must have liver function tests to assess liver enzymes and bilirubin levels.

The patient medication guide adds a section on the risk of problems with the electrical system of the heart (QT shortening). Symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Xcopri was approved in 2020 and treats partial-onset seizures (focal seizures) in adults.

Xcopri Safety Label Change

Read more about focal onset seizures at the Epilepsy Foundation.

Xyzal (levocetirizine dihydrochloride) Tablets and Withdrawal Itching

Prescription-strength allergy drug Xyzal has a new warning about the risk of extreme itching that may occur after stopping the medication after long-term use. The itching (or pruritus) may occur within a few days after discontinuation. If extreme itching does occur, symptoms may improve by restarting the medication or tapering the dose gradually.

So far, the over-the-counter versions of levocetirizine dihydrochloride have not yet been updated with this warning. Ceterizine (Zyrtec brand name) is also slated to have a similar warning added to its label. We reported on this topic in June: “Beware of Itching after Discontinuing These Allergy Drugs.”

Xyzal Safety Label Change

13 reports of itching with Xyzal on Ask a Patient website

More than 100 Reports of Itching with Zyrtec on Ask a Patient website

Drug Recall: Metoprolol Tartrate Tablets

Westminster Pharmaceuticals is recalling 16,672 1000-count bottles of Metoprolol Tartrate tablets (50 mg) and 4,456 1000-count bottles of Metoprolol Tartrate tablets (100 mg) due to the presence of nitrosamine above the acceptable daily limit. Nitrosamine impurities may increase the risk of cancer. The drug was manufactured by Renata PLC in Bangladesh. Metoprolol tartrate (Lopressor brand name) is a beta blocker treatment for high blood pressure. This recall began on August 6, 2025 and is a supplier-level recall. Consumers may wish check the Enforcement Report for specific batch numbers, lot numbers, and expiration dates.

FDA Enforcement Report
Read patient testimonials about metoprolol tartrate or Lopressor at Ask a Patient.

Drug Recall: Spironolactone Tablets

Sun Pharmaceuticals is recalling 11,328 100-count bottles of Spironolactone tablets (25 mg) due to the presence of a foreign substance, which has been identified as aluminum. The drug was manufactured by Frontida BioPharm, Inc. in Philadelphia, PA. Spironolactone (generic for Aldactone) treats high blood pressure, heart failure, edema (swelling), and cirrhosis. It is sometimes taken off-label for excessive hair growth, PCOS (polycystic ovarian syndrome) and acne. The recall began on August 5, 2025 and is a supplier-level recall. Consumers may check the Enforcement Report for specific batch numbers, lot numbers, and expiration dates.
FDA Enforcement Report

Find 274 patient testimonials about Spironolactone and 154 patient testimonials about Aldactone at Ask a Patient

Drug Recall: Compounded Semaglutide and Tirzepatide

Aequita Pharmacy, a licensed compounding pharmacy in Kirkland, Washington, is recalling over 2,000 multi-dose vials of injectable GLP-1 semaglutide and tirzepatide products because of “a lack of processing controls.” Lack of oversight in the compounding facility could impact medication sterility, dosage accuracy, and stability.

Semaglutide is the active ingredient in Novo Nordisk’s diabetes drug Ozempic and weight loss drug Wegovy. Strengths of the recalled semaglutide products ranged from .22 mg to 2.67 mg. Tirzepatide is the active ingredient in Eli Lilly’s diabetes drug Mounjaro and weight loss drug Zepbound. Strengths of the recalled tirzepatide products ranged from 2.2 mg to 16.6 mg. The recall began on July 18, 2025. Check the Enforcement Report for more product information.
FDA Enforcement Report

The Hill recently reported that online platforms (retailers and telehealth sites) are still flooding the market with illegal versions of semaglutide and other GLP-1 drugs:
“Copycat Ozempic, Mounjaro proliferate even in postshortage era”

Supplement Tips: Nutrafol Hair Growth Supplement

Consumer Lab’s Todd Cooperman, MD warns that Nutrafol, a popular dietary supplement taken to promote hair growth, contains concentrations of vitamins and minerals that could be excessive for some people. For example, Nutrafol contains 2,500 IU of vitamin D, which is three to four times as much as most adults need.

Nutrafol Men and Nutrafol Women supplements also contain 1,563 mcg (174% of the daily recommended value) of vitamin A (as beta-carotene). Cooper says that vitamin A supplementation is not recommended for the general population. In fact, too much vitamin A can cause hair loss.

The supplements also contain 3,000 mcg (10,000% DV) of biotin, 225 mcg (150% DV) of iodine from kelp, 25 mg (227% DV) of zinc, and 200 mcg (364% DV) of selenium. High amounts of biotin may reduce the absorption of anti-seizure meds and interfere with laboratory tests. Read more about hair growth dietary supplements (including Viviscal, which has a proprietary blend of “shark and mollusk powder”) at Consumer Lab:
Do Any Supplements Help for Hair Loss? (update on Nutrafol ingredients)
(This article is paywalled for members-only, but abstract is available.)

Nutrient Recommendations Calculator

Check out this USDA calculator to for a personalized daily nutrient recommendation based on your sex, weight, height, age, and activity level. The Dietary Reference Intakes (DRIs) were established by the Health and Medicine Division of the National Academies of Sciences, Engineering and Medicine. The nutrient recommendations include amounts of macronutrients, water, vitamins, and minerals you should be taking each day. In addition to the recommended amounts, the results also show the “tolerable” amounts of vitamins and minerals per day.
National Agricultural Library: Dietary Reference Intake Calculator

Dr. Lucy McBride, writer of “Are You Okay?” recently answered reader-submitted questions about:

• Restless Leg Syndrome: What are the causes and is it treatable without taking medication?

• Low Blood Pressure: Should aging adults with low blood pressure consider Salt and Mineral supplements?

• Hand tremors: Should a healthy 58-year old woman be concerned about a fine tremor in her hands?

Please visit our website at www.askapatient.com for more on drugs and treatments! Check out the archive of newsletters sent in 2025 using the Sitemap.

Did you miss the last edition of this newsletter? Read it here:

Breckenridge is recalling more than 12,000 30-count bottles of duloxetine delayed release, 40mg tablets due to the presence of nitrosamine impurities above FDA recommended limit. Nitrosamine impurities can increase risk of cancer. The drug is manufactured by Towa Pharmaceuticals in Barcelona, Spain.

Duloxetine is generic for the antidepressant Cymbalta. The FDA classified the recall as class II on July 30, 2025. Breckenridge issued a larger recall, for over 343,000 bottles, for other lots and strengths of this drug April 2025. Check the enforcement report for specific lot numbers and expiration dates. This recall is at the retail level but consumers may wish check product names, lot numbers, and expiration dates here:
Recall Announcement

Read or add patient reviews of Duloxetine or Cymbalta.

Drug Recall: Lisdexamfetamine Capsules

Sun Pharmaceuticals is recalling 5,488 bottles of 100-count lisdexamfetamine dimesylate 60 mg capsules due to “failed dissolution specifications,” or problems with long-term stability of the drug. The capsules are manufactured in New Brunswick, NJ by OHM Labs for distribution by Sun Pharma. The recalled units were sent to 17 distributors who may have further distributed the product nationwide.

Lisdexamfetamine is a stimulant and also sold as an ADHD treatment under the brand names Vyvanse and Elvanse. The recall was initiated on June 16 and classified as a Class II recall on July 11, 2025. Lisdexamfetamine comes in strengths ranging from 10 mg to 60 mg.

Recall Announcement (enforcement report) for lot numbers and expiration dates
Read or add patient reviews for Vyvanse.

Drug Recall: Timolol Maleate Ophthalmic Eye Drops by FDC Ltd. and Apotex

FDC Limited is recalling 154,176 5 ml bottles and more than 60,428 10 ml bottles of .5% timolol maleate Ophthalmic eye drops made by FDC Limited in Aurangabad, Maharashtra, India due to a detective cap and container. The spike of the cap may be lodged in the nozzle of the product bottle. This medication is used to treat glaucoma and is distributed by Rising Sun Pharmaceuticals. The recalls were initiated in April and June 2025 and classified as a class II recall in July.

Recall Announcement for the 154K recall
Recall Announcement for the 60K recall

Read or add reviews for Timolol Maleate.

Another glaucoma treatment is being recalled by Apotex. More than 6,000 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL are under recall due to lack of sterility. The drops were manufactured by: Apotex Inc., Toronto, Ontario, Canada. Classified as Class II recall on June 25, 2025.
Recall Announcement for Apotex

More Generics Recalls

Additional recalls are underway for the generic medications omeprazole, budesonide, rizatriptan, clomipramine hydrochloride, and cinacalcet. Also, find out the details about recent recalls for sucralfate, levothyroxine, and gabapentin.

Menopause Hormone Therapy: Boxed Warnings May Be Removed from Some Labels

On July 17, the FDA hosted a panel of medical experts to discuss menopause hormone replacement therapy (HRT), focusing on balancing its benefits with potential health risks. Many experts argued that vaginal-only estrogen products are much safer than oral pills and shouldn’t carry the same strict “boxed” warning currently required for all estrogen therapies. They urged the FDA to remove the boxed warning for low-dose vaginal estrogen, noting it deters women from using treatments that could help with symptoms like vaginal dryness, hot flashes, and bone health.

The current boxed warnings were added after the 2002 Women’s Health Initiative (WHI) long-term study found that estrogen and progesterone therapies taken after menopause had significant health risks for cancer, heart disease, and stroke. Experts remain divided on whether the warnings should remain for other forms of HRT, such as oral or systemic (like gels or patches) options.

The FDA is seeking public comments about this topic. Comments must be submitted at regulations.gov by 11:59 p.m. ET on September 24, 2025 under docket number FDA-2025-N-2589.

Urology Times: “Experts Urge FDA to Remove Black Box Warning on Low Dose Vaginal Estrogen”

FDA Press Release

Not everyone thinks the warnings should be removed. For another perspective, read this editorial by Georgetown University’s Adriane Fugh-Berman, MD and Barbara Mintzes, Ph.D.:
American Family Physician: “Menopausal Hormone Therapy: Limited Benefits, Significant Harms”

Pain Treatments: Prescription Opioid Label Changes

FDA is giving opioid pain medicine makers just 30 days to update prescribing information with risk information about the dangers of long-term use and additional warnings and information about dosage, addiction, digestive issues, interactions with gabapentin, and more.
FDA Press Release: “FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks”

Kratom Products Under Scrutiny

The FDA sent warning letters to seven kratom vendors accused of illegally marketing kratom-derived “7-OH” dietary supplements. It has also launched a public awareness campaign about the dangers of these products. Kratom is a plant native to Southeast Asia and has been used for years in teas and as a dietary supplement for its anxiety-relieving properties. But in concentrated amounts, such are found in “herbal” drinks such as “Feel Free” sold in gas stations, the 7-OH substance, derived from the plant, can be highly addictive.

The FDA says it is specifically targeting 7-OH, a concentrated byproduct of the kratom plant and that it is not focused on natural kratom leaf products. It warns that 7-OH can have addictive qualities similar to opioids and serves no medical use.

The FDA is also calling on the DEA to classify 7-OH as a Federal Schedule 1 drug, which makes it illegal and places it in the same category as heroin. Those opposed to the illegal designation say that while regulation is needed, making it a Schedule 1 drug is an over-reaction. They say recent actions are influenced politically by a new group called the Global Kratom Coalition (GKC).

The Holistic Alternative Recovery Trust, an advocate for plant-based compounds to address opioid addiction, says that the FDA’s recommendation disregards how 7-OH is used in the real world.

Pain News Network: “FDA Warns About Kratom Extracts”
People’s Pharmacy: “What is Kratom and why does the DEA want to Ban it?”
FDA Press Release: “FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers”
More from FDA: FDA Resources on 7-OH with links to the letter sent to doctors warning about the emerging health dangers, Q&A for consumers, scientific data about 7-OH and more.

Note: you should have received two newsletters today: this edition for drug safety updates and another with highlights of new drug approvals and other treatments news.

Visit our website at www.askapatient.com for patient reviews about medications.

Leo Pharma’s Anzupgo (delgocitinib) cream treatment received FDA approval for treating moderate to severe chronic hand eczema. This is the first medication of its kind that is steroid-free and specifically developed for use on the hands. Chronic hand eczema is common, affecting about 10-15% of the population. The condition is characterized by painful, itchy, dry, thickened, cracked skin on the hands.
American Journal of Managed Care: "FDA Approves Delgocitinib for Moderate to Severe Hand Eczema:"
Anzupgo drug label
Read more about hand dermatitis (or hand eczema) at Dermnet.

Expanded Drug Approval: Kerendia (finerenone) for Heart Failure

Bayer’s Kerendia (finerenone) received expanded approval to treat adults with heart failure with left ventricular ejection fraction (LVEF) of ≥40%. Heart failure is a condition in which the heart is not able to pump blood to the rest of the body efficiently. Ejection fraction refers to how well your heart pumps blood: it is the percent blood pumped out of your heart’s ventricles each time it contracts.

Kerendia was originally approved in 2021 to prevent serious kidney failure and cardiac events in patients with chronic kidney disease (CKD) associated with type 2 diabetes. Now, patients need not have kidney disease and type 2 diabetes in order to take Kerendia. However, Kerendia can cause worsening of kidney function in patients with heart failure. For more, read the Kerendia revised label.

Fierce Pharma: Bayer Scores FDA Expansion for Kerendia
Read more about ejection fraction at Cleveland Clinic and heart failure at Medline Plus.

Sarepta’s Duchenne Treatment Suspended and Clinical Trials Halted Due to Patient Deaths

Update: The FDA partially lifted its ban on Elevidys, allowing treatment to resume for ambulatory patients (those with the ability to walk). These tend to be younger patients.

After initially refusing to do so, Sarepta paused distribution of its gene therapy for Duchenne muscular dystrophy (DMD) and halted clinical trials of a related drug in response to an FDA request. Two teenage patients recently died (one in March and one in June) after taking Elevidys (delandistrogene moxeparvovec), and a 51-year-old clinical trial participant died this month after taking Sarepta’s gene therapy for limb-girdle muscular dystrophy (LGMD). All three patients died from liver failure within weeks of receiving the one-dose intravenous infusion.

Duchenne, like most types of muscular dystrophy, mainly affects boys, with symptoms beginning around age four. The condition worsens over time, leading to weakness and wasting away of the body’s muscles. Elevidys was approved in 2023 under the accelerated approval pathway for four-and five year old ambulatory patients (those with ability to walk). It then received traditional approval for ambulatory patients age four and up and accelerated approval for non-ambulatory patients age four and up in 2024. This expanded approval was controversial. Last week, a committee at the European Union’s European Medicines Agency (EMA) said it was recommending against approval of Elevidys.

A journalist with a lot at stake in these developments (he has a son with Duchenne), writes about the Elevidys “showdown” and presents possible scenarios for what might happen next:

Duchenne Decoded

Sarepta and the Terrible, Horrible, No Good, Very Bad Week

In the spring of 2023, the biotech company Sarepta was riding high. The company, which develops treatments for muscular dystrophy, had managed to secure FDA approval for Elevidys, its gen…

Read more

a year ago · 5 likes · 1 comment · Winston C-S

Testosterone Drugs: High Blood Pressure and Blood Clotting Warnings

In response to an FDA directive issued in February 2025, all testosterone product labels were updated this month and no longer include a boxed warning about increased risk of heart attacks and strokes. Results from a clinical trial used as the basis for removing the warning about cardiac risks, the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE study), are also included in the update.

Testosterone products have a new warning about risk of increased blood pressure, based on required post-market ambulatory blood pressure (ABPM) studies, which confirmed a class-wide increase in blood pressure with testosterone. Testosterone is not recommended for use in men with uncontrolled hypertension; patients should monitor their blood pressure during treatment.

The drug labels also warn that cases of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Symptoms of venous thromboembolism (blood clot in the veins) may include lower limb pain, edema (swelling), erythema (skin reddening), and shortness of breath or chest pain. Patients experiencing these symptoms should discontinue the drug and seek urgent medical care.

The revised warnings affect all formulations of testosterone replacement therapy, including gels, tablets, patches, buccal (applied to upper gum or in the cheek), capsules, and injections. These medications are approved for males with conditions associated with a deficiency or absence of testosterone, which is either primary hypogonadism or hypogonadotropic hypogonadism. The condition is also referred to as “Low-T” or low testosterone.

Primary hypogonadism happens when the testes themselves do not function properly. Hypogonadotropic hypogonadism occurs there is a problem with the pituitary gland, which is the gland responsible for releasing hormones which in turn trigger the testes to release hormones. Testosterone was initially approved as a drug treatment in 1953.

Recently revised testosterone drug labels reported in the FDA’s Safety Related-Labeling Changes Database include: Azmiro (testosterone cypionate) injection, Aveed (testosterone undecanoate) injection, Androgel (testosterone) gel, Jatenzo (testosterone undecanoate) capsules, Kyzatrex (testosterone undecanoate) capsule, liquid filled. If you are taking a different testosterone replacement therapy, it will have similar label updates .

Read more about hypogonadism (low testosterone) at MedLine Plus.

Opdivo (nivolumab) Injection for Intravenous Use

Cancer drug Opdivo updated the postmarketing experiences section of its label to add that cases of tumor lysis syndrome have been reported. Considered a medical emergency, tumor lysis syndrome happens when cancer cells, released into the bloodstream as a result of cancer treatment, release toxins that can injure the kidneys. Tumor lysis syndrome may involve high uric acid, high phosphorous levels, or high potassium levels in the bloodstream. Opdivo was approved in 2014 and treats a variety of cancers.

FDA Safety Update for Opdivo and Opdivo Revised Label

Read more about Tumor Lysis Syndrome at Cleveland Clinic.

Medication Tips: Green Tea and Drug Interactions

The People’s Pharmacy’s Terry Graedon presents results from studies that examine the effect of green tea on absorption rates for some prescription drugs. For example, one study showed that green tea can lower concentrations of the beta blocker blood pressure drug nadolol (Coreg brand name), atorvastatin (Lipitor brand name) for cholesterol control, digoxin for heart failure, fexofenadine (Allegra brand name) for allergies, lisinopril for high blood pressure and osteoporosis medication raloxifene (Evista brand name).

On the other hand, green tea increased the absorption of sildenafil (brand name Viagra).

Green tea does not appear to interact with metoprolol (Lopressor brand name), another beta blocker drug. Read more tips about green tea interactions here:

“Does Green Tea Interact with Prescription Drugs?” at The People’s Pharmacy

Taking a blood thinner like warfarin (Coumadin brand name) or Plavix? Check out Cleveland Clinic’s guidance on what to avoid when taking blood thinners.

Medication Tips: Treatments for Anemia in Older Adults

Anemia is a common blood disorder affecting between 12-20% of those age 60 and up. Left untreated, it can cause symptoms like fatigue, weakness, headaches, leg cramps, feeling cold, and brain fog. In older patients, these signs are sometimes mistaken for normal aging, so the condition may not be documented within a patient’s medical record. Anemia can be triggered by a variety of conditions, including nutritional deficiencies, surgery, internal blood loss from polyps or ulcers, and chronic diseases like heart disease, kidney failure, or inflammatory bowel disease. Frustratingly, for about one-third of patients, the underlying cause cannot be explained. Sometimes the condition comes and goes, for no apparent reason.

First-line treatment for anemia is usually oral iron supplements, or sometimes vitamin B12 or folate. Iron pills can be hard to tolerate for many seniors (causing side effects like nausea or constipation) and may be ineffective. Read KFF’s report on anemia in older adults and why in some cases intravenous iron infusions may work better than oral supplements:

KFF News: “Maybe It’s Not Just Aging. Maybe It’s Anemia”

In severe cases of iron deficiency anemia, a patient may need a blood transfusion:
Medpage Today: “Everything you need to know about blood transfusions and anemia”

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The FDA issued a Drug Safety Communication about the serious risk of hyperthermia, or overheating, for motion sickness drug Transderm Scop (scopolamine transdermal system). The scopolamine-containing patch is applied behind the ear and delivers 1 mg of medicine over about 3 days.

The medication can affect the body’s ability to maintain a stable internal temperature and can also reduce sweating, which may contribute to an increase in core body temperature. Heat-related complications may lead to confusion, loss of consciousness, coma, or death. In reported cases, hyperthermia occurred most often within 72 hours after the Transderm Scop patch was applied for the first time. The FDA notes that warm environmental temperatures and use of external heat sources, such as a heated blanket, exacerbate the risk.

Patients using the patch who have a high body temperature or are not sweating in warm conditions should remove the patch and contact a doctor. People over the age of 65 and those under the age of 17 may be at greater risk of hyperthermia. (The med is not approved for pediatric patients, but is sometimes prescribed “off-label.”) Transderm Scop was approved in 1979.

FDA Announcement: “FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)”

Transderm Scop FDA Safety Label Change

Read or add ratings for Transderm Scop at Ask a Patient website.

Caprelsa (vandetanib) tablets and Osteonecrosis of the Jaw

Thyroid cancer treatment Caprelsa had a safety update to warn that osteonecrosis, including osteonecrosis of the jaw (ONJ), has occurred during treatment. Exposure to denosumab (Prolia brand name) or bisphosphonate drugs like alendronate (brand name Fosamax) may increase the risk of ONJ. Patients should avoid invasive dental procedures while taking Caprelsa. Caprelsa was approved in 2011.

In people with healthy bones, new bone is always replacing old bone. In osteonecrosis, the bone breaks down faster than the body can make enough new bone. https://rheumatology.org/patients/osteonecrosis-of-the-jaw-onj

Read more about osteonecrosis at MedLine Plus

Caprelsa Safety Label Change, and Revised Drug Label

Hyzaar (hydrochlorothiazide; losartan potassium) tablets and Angioedema

Blood pressure drug Hyzaar now warns that angioedema (swelling) side effects have included swelling of the intestines, or “visceral angioedema.” Hyzaar is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic or “water pill.” Hyzaar was originally approved in 1994.

Rare case reports of losartan-induced visceral angioedema have been reported in the medical literature.

Hyzaar FDA Safety Label Change

Read or add ratings for Hyzaar at AskaPatient website.

Xarelto (Rivaroxaban) Tablets, Oral Suspension and Risk of Spleen Rupture

Xarelto treats and prevents deep vein thrombosis or DVT (a type of blood clot usually in the leg) and pulmonary embolism, which is a blood clot in the lung. The medication is also taken to prevent strokes and blood clots in people with atrial fibrillation that is not caused by heart valve disease.

Xarelto has a new warning about the risk of internal bleeding from any organ and also warns about the risk of spleen rupture. Patients are advised to get medical help right away if they experience symptoms of a ruptured spleen: upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort. Xarelto was originally approved in 2011.

Xarelto Safety Label Change, and Revised Drug Label

Read or add ratings for Xarelto at Ask a Patient website.

GLP-1 Drugs and Kidney Injury

GLP-1 drugs are used to treat type 2 diabetes and/or weight loss. Many of the drugs in the category have new warnings about the risk of serious kidney injury caused by dehydration that is associated with GLP-1 gastrointestinal adverse effects like diarrhea and vomiting. The labels have also been edited for a more uniform presentation of side effects and risk information for the drugs in the GLP-1 category.

Some of the GLP-1 drug labels were also updated to add that there have been post-marketing reports of hair loss (alopecia) and the neurological symptom of “altered sense of touch,” or dysesthesia. Ozempic, Rybelsus, and Zepbound already had made all of these changes, so were not included in the recent updates received by the FDA. GLP-1s with strengthened warnings about kidney injury include:

Bydureon BCISE extended-release (exenatide synthetic) subcutaneous weekly injection (approved in 2017)
The postmarketing experience section also now includes reports of dysesthesia (altered sense of touch). Bydureon Extended Release Safety Label Change

Byetta (exenatide synthetic) subcutaneous twice-daily injection (approved in 2005)
The postmarketing experience section also now includes reports of dysesthesia (altered sense of touch). Byetta FDA Safety Label Change

Mounjaro (tirzepatide) subcutaneous weekly injection (approved in 2022) The postmarketing experience section also now includes reports of alopecia (hair loss).
Mounjaro FDA Safety Label Change

Soliqua 100/33 (insulin glargine and lixisenatide) subcutaneous daily injection (approved in 2016) The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Soliqua FDA Safety Label Change

Trulicity (dulaglutide) subcutaneous weekly injection (approved in 2014)
Added new clinical trials reports of stomach problems (gastrointestinal effects). Trulicity FDA Safety Label Change

Victoza (liraglutide) subcutaneous daily injection (approved in 2010) Victoza FDA Safety Label Change

Xultophy 100/3.6 (insulin degludec and liraglutide) subcutaneous daily injection (approved in 2016) The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Xultophy FDA Safety Label Change

Saxenda (liraglutide) subcutaneous daily injection (approved in 2014)
The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Saxenda FDA Safety Label Change

GLP-1 Drugs and Pancreatitis

The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) will be investigating adverse effects of GLP-1 drugs on the pancreas. This is in response in an increase in reports of acute pancreatitis to the MHRA Yellow Card scheme, which monitors adverse reactions to medications and medical devices in the UK.
The Guardian: “Hundreds of weight loss and diabetes jab users report pancreas problems”

Medication Tips: Cancer Treatments

Chemocare website is a resource for patient and caregivers with questions about cancer drugs. Find out what you should tell your health care team before starting a treatment, learn about drug interactions, how to store it (if applicable), side effects to expect, and self-care tips. The resource covers everything from novel immunotherapies and targeted radioligand treatments to taxane-based chemotherapies. The “Cancer Answer Line” at 1.844.268.3901 has advanced practice nurses and coordinators who will answer cancer-related concerns of patients, non-patients, caregivers, and even physicians (from 8am to 4:30pm EST). The site is hosted by Cleveland Clinic.

Did you miss our last Drug Safety Update? Check it out here:

Visit our website at www.askapatient.com for drug ratings and reviews submitted by patients. Please share the publication or click the “heart” button below to help this newsletter reach more readers!

Amneal announced a recall of Bactrim generic tablets due to potential microbial contamination. Amneal is recalling 100 and 500 count bottles of Sulfamethoxazole and Trimethoprim 400 mg/80 mg strength tablets. Black spots found on the surface of a tablet were identified as the fungus Aspergillus. The product was distributed between December 2024 and May 2025 and has an expiration date of June 2027. The label indicates it was manufactured by Amneal in Ahmedabad, India. This medication is often used to treat urinary tract infections and ear or other respiratory infections. Example product label is posted below.
FDA Consumer Recall Announcement

Read or add patient reviews of Sulfamethoxazole/Trimethoprim at Ask a Patient. Last year, sulfa drugs had safety-related label updates:

Recall: Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, Orajel Baby Teething Swabs

Church & Dwight announced a recall of its homeopathic Zicam Cold Remedy Nasal Swabs, Zicam AllClear Nasal Cleaning Swabs and Orajel baby teething swabs due to potential microbial contamination (fungal) in the cotton swab part of the products. To date, no serious adverse events associated with the affected products have been reported. Check press release for product codes. Church & Dwight is offering a refund for recalled products.
FDA Consumer Recall Announcement and Church & Dwight Recall and Refund Information

Drug Recall: Carvedilol tablets (Coreg generic)

More than 200,000 bottles of 100 and 500-count 3.125 mg strength carvedilol tablets made by Glenmark are under recall due to nitrosamine impurities above the acceptable limit. Carvedilol is a “beta blocker” type of blood pressure drug and is a generic for Coreg brand name. This recall is directed at pharmacies and suppliers, but consumers may check the FDA Enforcement Report for lot numbers and expiration dates of affected products. The product label indicates Glenmark’s Goa, India facility as the manufacturing location.

This is the second recall of carvedilol by Glenmark this year. In February, 6.25 mg and 12.5 mg strength tablets were also recalled. Nitrosamine impurities occur due to manufacturing process problems. Check the Enforcement report for a list of lot numbers and expiration dates for recalled carvedilol, including an update of the recalled products from February.

In December 2022, Glenmark received a warning letter from the FDA after an inspection of its Mumbai, India facility found many deficiencies and violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

Read or add patient reviews for Coreg or Carvedilol at Ask a Patient.

New Warning: Depakote (dlproex sodium) delayed-release tablets

Bipolar, seizure, and migraine headache prevention drug Depakote has a new warning about the risk of facial swelling (angioedema) and a serious drug hypersensitivity reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Depakote was approved in 1983. Symptoms of DRESS include fever, rash, facial swelling, enlarged lymph nodes and kidney or liver injury.

Depakote FDA Safety label change

Read more about drug hypersensitivity syndrome at the American Academy of Allergy, Asthma, and Immunology:
https://www.aaaai.org/conditions-treatments/related-conditions/dress

Patient reviews of Depakote

New Warning: Lamictal (lamotrigine) tablets, oral suspension, orally disintegrating tablets and extended release tablets

Bipolar drug and seizure drug Lamictal products have new warnings of potential interactions estrogen-containing drugs including oral contraceptives and hormone replacement therapy (HRT). Estrogen may reduce the effectiveness of Lamictal. Patients should notify their doctor if they use or plan to use estrogen-containing medications while taking Lamictal.

Safety Label Change: Lamictal, Lamictal CD, Lamictal ODT Lamictal XR (extended release tablets)

In 2018, the FDA issued a drug safety communication for Lamictal about a serious immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), which causes an uncontrolled response by the immune system. Like DRESS (mentioned above as a risk for Depakote), HLH has symptoms of fever, rash, and internal organ involvement. Lamictal was approved in 1994.

Research: GLP-1 Drugs and Risk of Eye Disease

A University of Toronto study found that diabetes patients who use GLP-1 drugs were twice as likely to develop neovascular age-related macular degeneration (nAMD) than diabetes patients not taking GLP-1 drugs. The two-fold increase in nAMD was most evident in people using these drugs for the longest period of time. The population-based retrospective cohort study included 139,002 patients with an average age of 66, including 46,334 patients who were exposed to GLP-1 drugs and 92,668 matched patients who had not taken GLP-1 drugs. The study was published in JAMA Ophthalmology.

Fierce Pharma: Diabetes patients who use GLP-1s may have a higher risk of serious eye disease
Review of Optometry: Glp1-drugs-linked-to-small-but-worrying increase in wet AMD risk

AMD is a leading cause of vision loss in people 50 years or older. Neovascular AMD (also known as “wet” AMD) is less common and more serious than “dry” AMD. With wet AMD, abnormal blood vessels grow under the retina, which may leak blood, causing serious vision problems or blindness. Learn more about the two types of Age-related Macular Degeneration from the American Academy of Ophthalmology, including descriptions of treatments, helpful vitamins, and an “Amsler grid” you can use to monitor your vision:
https://www.aao.org/eye-health/diseases/amd-macular-degeneration

Another serious eye condition, non-arteritic anterior ischemic optic neuropathy (NAION) has been linked to semaglutide, the ingredient in GLP-1 drugs Ozempic and Wegovy.

FDA Rolls Out Artificial Intelligence Tool

Martin Makary, FDA Commissioner, announced that he had set an aggressive timeline to scale the use of AI agency-wide: by June 30, 2025. In fact, the new tool was rolled out early, on June 2. The roll-out may have been premature. FDA staff found that the AI tool provided summaries about drugs that were either completely or partially wrong. Originally called CDER-GPT for use within the FDA's Center for Drug Evaluation and Research, it is now rebranded for use organization-wide as “Elsa.”

ARS Technica: “FDA rushed out agency-wide AI tool—it’s not going well”

Generic Drugs Concerns: Live Webcast on June 25

Have you ever noticed something different about a new generic drug you were taking? Usually there is no way to know if drug quality is to blame for new side effects or to explain why the drug is not working. Learn more about generic drug safety and quality and what you can do about it at an educational webinar for consumers hosted by MedShadow Foundation. The expert panel includes investigative journalists, pharmaceutical researchers, and patient advocates.

Program: “Investigating Generic Drugs: How Poor Quality Generics Cause Harm”
Host: Suzanne Robotti, Founder and President, MedShadow Foundation
Panelists: Katherine Eban, Journalist and Author, Bottle of Lies; Joe Graedon, President, The People’s Pharmacy; David Light, Co-founder and President, Valisure
When: June 25 at 4 pm Eastern Standard Time (sign up to receive access to the recording even if you can’t attend live)
Sign Up: https://medshadow.org/webinar-how-poor-quality-generic-drugs-cause-harm/

Related Reading: Check out our explainer article on ingredients variations in generic drugs, along with a description of Valisure’s Drug Quality Testing Project for the U.S. Defense Department.
Generic Drugs: Ingredients and Quality Concerns

Supplement Tips

Creatine is naturally stored in the muscles; when taken as a supplement it can boost muscle mass and performance. In her Friday Q&A, Dr. Lucy McBride, writer of “Are you Okay?” answers a question from a patient about creatine supplements:
”Is creatine worth trying for menopausal women who lift weights?”
https://lucymcbride.substack.com/i/165209594/question-creatine-supplements-and-menopause

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Visit us at AskaPatient.com for medication and vaccine ratings and reviews provided by patients along with more news and health information.