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.

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

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.

Did you miss our last newsletter? Read it here:

Here is one of our most-read newsletters in 2025:

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

Did you miss our Thanksgiving edition? View it here:

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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Would you like to comment on this article that you received by email - but you’re not a Substack member? Just simply reply to this email and I will get your message. (No one else will!) In particular, if you know of useful articles with medication tips you’d like to share or topics you would like covered, let me know. Thank you.

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

7 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

6 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.

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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

8 months 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

Did you miss the last newsletter? Check out:

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

Spravato (esketamine) nasal spray is a psychedelic (mind altering) treatment for very severe depression in patients who are suicidal or whose depression is severe and treatment-resistant. It may be used in conjunction with oral antidepressants or taken as a standalone treatment, administered once or twice a week. The medication is only available through a restricted distribution program called the SPRAVATO^® REMS because of risks of sedation, dissociation (emotional detachment), and respiratory depression. The medication is only administered in a certified healthcare setting where the patient can be monitored for at least two hours after administration.

The label was updated to add the adverse reaction bradycardia (where the heart beats slower than normal, involving a resting heartbeat of less than 60 beats per minute). Bradycardia is a type of arrhythmia, or irregular heartbeat. Ketamine was approved in 1970, while the Spravato formulation (esketamine) was approved in 2019.

Read more about types of irregular heartbeats at MedLine Plus: https://medlineplus.gov/arrhythmia.html

FDA letter approving the safety update
Last year, Spravato received an expanded approval.

FDA Discontinues "REMS" drug safety programs for Clozapine, Ambrisentan, Macitentan

REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program that the US Food and Drug Administration (FDA) requires for certain medicines with serious safety concerns, such as drugs that may cause birth defects or pose extreme risk to a patient if not taken strictly according to instruction. Three drugs recently had their REMS requirements discontinued.

Some in the health care community are concerned that due to FDA job cuts, REMS discontinuations are happening that shouldn’t, or are slow to be communicated. Chemical and Engineering News reports that “pharmacists say some safeguard programs for risky medications have stopped, basic information about others is unavailable.”
https://cen.acs.org/safety/drug-safety/FDA-job-cuts-hinder-drug/103/web/2025/05

Clozapine tablets

Schizophrenia drug clozapine’s REMS aimed to reduce the risk of severe neutropenia (low white blood cell count). Its REMS required that prescribers report results of absolute neutrophil count (ANC) blood tests before pharmacies dispensed clozapine. But this requirement was sometimes a barrier to treatment among low income or homeless mentally ill patients, and a major reason for the REMS discontinuation. Warnings about neutropenia remain on the drug label, and prescribers should still be aware of and monitor for this side effect. Clozapine was approved in 1989. It is available as a generic and by the brand name Clozaril.
Clozapine REMS announcement
The REMS had been in effect since 2015, but for years, advocates for its removal have suggested that the safety requirements did more harm than good. A recent opinion column in “The Hill” says that “the Risk Evaluation and Mitigation Strategies (REMS) program has been largely responsible for the underprescription and underuse of clozapine, the only FDA-approved drug for treatment-resistant schizophrenia, the most severe form of the disorder.”

The Hill: “Is the FDA contributing to the homelessness crisis?”

Patient experiences with Clozaril (clozapine) at Ask a Patient website

Ambrisentan and Macitentan tablets

The FDA also discontinued the REMS for ambrisentan (Letairus brand name) and macitentan (Opsumit brand name). These are drugs used to treat high blood pressure in the lungs, or pulmonary arterial hypertension and the REMS was set up to mitigate the risk of fetal toxicity. Ambrisentan and macitentan continue to have boxed warnings about the risk of birth defects and both are contraindicated during pregnancy. Females of reproductive potential should get a pregnancy test before starting the drug and use effective contraception before, during, and for one month after treatment.

FDA letter removing Ambrisentan REMS

Macitentan REMS removal announcement

Removal of Dyes from Children’s Claritin

Children’s Claritin chewable tablets (10 mg and 5 mg) for allergies will soon be “dye-free,” according to documents filed with the FDA and a letter approving of Bayer’s new packaging. Currently, grape flavor gets its purple color from FD&C blue No.2 and D&C red no. 27.

FDA letter: accessdata.fda.gov/drug…

Fluoride Tablets and Drops to be Banned

The FDA announced that it plans to study the health impacts of ingestible fluoride, such as chewable tablets and drops used by young children to help prevent tooth decay. It will move towards a ban on the products, which have never been FDA-approved in the first place. This ban would not include rinses, toothpastes, or non-ingested fluoride. “Fluoritab” cherry flavored chewable sodium fluoride tablets and flavored fluoride drops pictured below are examples of the products.

For ingestible sodium fluoride products, such as the chewable tablet pictured below, the label states: “DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. “

FDA Press Release on Fluoride Product Concerns

Izervay and Syfovre Marketing Tactics

Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) are solutions injected directly into the eye as a treatment to slow the progression of an eye disease called geographic atrophy (GA). Lackluster sales, likely due to the reluctance of ophthalmologists to prescribe these new drugs, could be behind the recent surge in direct-to-consumer advertising for the products.

Investigative journalist Martha Rosenburg’s “Repetitive Drug Ads Raise Questions in Chicago Market” points out serious safety and effectiveness concerns along with marketing contradictions in the Izervay ads.

Martha’s Newsletter

Repetitive Drug Ads Raise Questions in Chicago Market

Anyone who listens to WBBM or WLS radio stations in Chicago or baseball games of the Chicago Cubs has heard them: seemingly incessant jingles selling a drug for an eye condition most have never heard of…

Read more

a year ago · Martha

Why opthamologists are hesitant to prescribe the treatments for GA:
Global Newswire: “Treating Geographic Atrophy Remains a Tough Call for Ophthalmologists as They Voice Hesitancy to Prescribe Complement Inhibitors”

So far, the two GA drugs have not been approved for use in any country except the U.S. Both Izervay and Syfovre were approved by the FDA in 2023.

Pros & Cons of Korean Sunscreens

Korean skincare products, including sunscreens, have become very popular in the U.S. in recent years. Here are some of the reasons people are buying them, along with some potential concerns, according to Consumer Lab, a provider of independent laboratory test results for health and nutrition products.

Pros:

1. Lightweight formula is reported to be more comfortable than many U.S. sunscreen products and is absorbed by the skin like a light moisturizer.

2. Appears to provide better UV-A protection than U.S- made sunscreens, which only are rated for UV-B protection. UV-B sun rays cause sunburn, but UV-A rays can also be damaging to skin and lead to premature aging. According to Consumer Labs, the EU and Korea require sunscreen products to have protection against UVA radiation that is at least one-third of the sun protection factor (SPF) for UV-B, while the US only requires "some" UVA protection (referred to as “broad spectrum” protection).

Consumer Labs says that other than zinc oxide and avobenzone, most sunscreen ingredients allowed in the U.S. have not demonstrated strong protection against UVA rays.

Cons:

1. Since they aren’t regulated as strictly as those made in the U.S., some products may not provide the amount of UV protection claimed on the labels.

2. Popular Korean sunscreen products, such as Beauty of Joseon’s Relief Sun: Rice + Probiotics SPF50+ PA++++, are not sold in the U.S. as the products contain unapproved UV filters. Relief Sun and others may be purchased on international shipping sites, but Consumer Labs says the products may not be authentic.

Concerned about getting enough Vitamin D from the sun while you use sunscreen? Research has found that even with sunscreen use, your skin will still absorb enough sunlight to produce Vitamin D.

https://www.consumerlab.com/answers/cancer-causing-compounds-benzene-benzophenone-in-sunscreen/carcinogens-sunscreen/#korean-sunscreen-concerns
(Note: a subscription to Consumer Labs is required to read the linked article, which also contains information about benzene levels for specific sunscreen products available in the U.S. In general, spray sunscreens are far more likely to contain benzene than lotions, but not all tested spray sunscreens had dangerous levels of benzene.)

Did you know? The FDA regulates sunscreens as nonprescription drugs.

New Warning about “Gas Station Heroin,” or Tianeptine-Containing Supplements

FDA released a new warning about dangerous products containing high amounts of tianeptine. These products, known as “gas station heroin,” are sold as health supplements or “cognitive enhancers” at convenience stores in gas stations and convenience stores. The ingredient is not approved in the U.S. but is contained in certain antidepressants in other countries at much lower concentrations. A year ago, specific products, including “Neptune’s Fix,” sold as a pill or powder that is combined with water into a drink were under recall.

Adverse effects can include seizures, loss of consciousness, interactions with other medications, and more. Read FDA commissioner Martin Makary’s warning letter for more about products to avoid.

"Gas Station Heroin" Warning and Recall from Ask a Patient newsletter, April 2024.

Just in: “A landmark event in medicine was reported this week that has implications well beyond its likelihood of saving a baby’s life. Until now, commercially available CRISPR genome editing (Casgevy) was not capable of directly fixing a genomic defect.”
Read why Eric Topol is excited about this breakthrough in Ground Truth’s “The First Human to Undergo In Vivo CRISPR 2.0 Personalized Genome Editing”

Medication Tips:

This week, Dr. Lucy McBride, writer of “Are You Okay?,” answered questions from women and men about hormone replacement therapy:

• How long should I stay on HRT?

• Does vaginal estrogen help prevent UTIs?

• A 58-year-old man with “lower end of normal” testosterone levels asks if he should consider testosterone therapy

  ---

  

  Did you miss the last drug safety update? Check out:

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

A large recall is underway for duloxetine, generic for Cymbalta brand name antidepressant. 343,344 bottles of duloxetine 30 mg. delayed release tablets and 16,475 bottles of duloxetine 60 mg tablets made by Towa Pharmaceuticals Europe in Barcelona, Spain for Breckenridge Pharmaceutical (a Towa company). The medications were flagged for containing higher than acceptable levels of nitrosamine impurities, which can increase the risk of cancer. Nitrosamine impurities are not caused by unsanitary conditions in the facility; they occur during the manufacturing process.

This recall is the latest in a string of similar recalls that have occurred over the past six months. Towa Pharmaceuticals also recalled about 7,100 bottles of duloxetine in October for the cancer-causing chemical. In December, more than 233,000 bottles of duloxetine delayed-release capsules were recalled by Rising Pharmaceuticals (made in India) for same reason. In March 2025, more than 1.5 million bottles of Glenmark’s atomoxetine, (generic for Strattera), made in India, were recalled for nitrosamine impurities.

The recall is directed at pharmacies, but consumers may check the FDA Enforcement Report for affected product lot numbers and expiration dates.
FDA Enforcement Report

FDA Safety Updates Delays Continue

The FDA Safety-Related Labeling Changes (SrLC) database is a primary source of information for both this newsletter (Ask a Patient® Health News: Drugs & Treatments) and for the FDA drug side effects series I write for the MedShadow Foundation website. MedShadow’s Emma Yasinski interviewed me about delays in safety updates, which the FDA attributes to Health & Human Services (HHS) agency restructuring. Check out:
Mission Critical Update: Medication Safety Updates from the FDA Delayed

The safety updates described in today’s newsletter were obtained from four recent FDA supplemental applications (for gabapentinoids) or were already in the queue from SrLC updates from March (for tetracyclines and Trodelvy).

New Warnings for Gabapentinoids

Gabapentin (brand name Neurontin) treats shingles-related pain, nerve pain, seizures, and a variety of other conditions. (See our article, “What is gabapentin used for and why are so many patients taking it?”) Pregabalin (brand name Lyrica) belongs to the same family of medications (gabapentinoids) and treats diabetic peripheral neuropathy (a type of nerve pain in the feet) and fibromyalgia.

Four gabapentinoids have new warnings about the risk of suicidal thoughts and the risk of withdrawal symptoms. The FDA sent letters to the sponsors of these products with instructions to add new safety information to drug labels:
Neurontin (gabapentin), Gralise (gabapentin), Horizant (gabapentin enacarbil), Lyrica and Lyrica CR (pregabalin).

The labels now state that reactions upon discontinuation may include, but are not limited to, seizures, depression, suicidal ideation and behavior, agitation, confusion, disorientation, psychotic symptoms, anxiety, insomnia, nausea, pain, sweating, tremor, headache, dizziness, and malaise. Patients are advised to taper the medications gradually over a minimum of 1 week.

For many years, the Ask a Patient website has received anecdotal reports of withdrawal problems in Lyrica and Neurontin withdrawal and suicidal ideation with Lyrica and Neurontin and other gabapentin-type drugs. The potentially addictive nature of the medication was covered in our January 2023 newsletter: “Promise and Problems with Gabapentin.”

For more information about each drug, with updated side effects, warnings, and dosage instructions, read:
Neurontin revised label
Gralise revised label
Horizant revised label
Lyrica revised label

If you have ever used any of these products, please take a moment to share your opinion or experience with the medication at Ask a Patient website.

Tetracycline Antibiotics and Fixed Drug Eruptions

Several tetracycline-containing antibiotics had safety label updates to warn that severe skin hypersensitivity reactions called fixed drug eruptions (FDE) have occurred. With an FDE reaction, skin reactions worsen each subsequent time the drug is used. A very severe variant of FDE is “generalized bullous fixed drug eruption” (GBFDE), which can be life-threatening. The tetracycline antibiotics with the new warning include:

Pylera (bismuth subcitrate potassium; metronidazole; tetracycline)
Pylera FDA Safety Label Change

Doryx (doxycycline hyclate) delayed release tablets
Doryx FDA Safety Label Change

Minocin (minocycline hydrochloride)
Minocin FDA Safety Label Change

In December 2024, a group of NSAID pain drugs had new warnings about fixed drug eruptions: “Skin Reactions and NSAIDs'.”
In July 2024, a group of metronidazole-containing antibiotics (including Flagyl and Pylera, which is also contains tetracycline) had new warnings about severe skin reactions. “Metronidazole antibiotics: severe skin reactions and tinnitus.”

Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use

Trodelvy, a treatment for advanced breast cancer, added a boxed warning about the risk of severe, life-threatening, or fatal neutropenia (low white blood cell count) and for the risk of severe diarrhea. Because of unfavorable clinical trials results for its use as a bladder cancer treatment, Trodelvy is no longer approved for treating urothelial (bladder) cancer. Trodelvy was initially approved in 2020.
Trodelvy FDA Safety Label Change

FDA Announces Phase-out of Animal Studies for Preclinical Safety Trials of New Drugs

On April 10, FDA commissioner Martin Makary announced that the FDA has a plan to encourage the use of New Approach Methodologies (NAMs), such as AI-driven computational models, organoids, and organ-on-a-chip systems for Investigational New Drug Applications (INDs) to demonstrate preclinical (before human clinical trials) drug safety. Read more and answer a quick poll on whether you think this is a good idea:

New and Expanded Drug Approvals

Imaavy (nipocalimab-aahu) intravenous infusion

J&J’s Imaavy was approved to treat myasthenia gravis (gMG), a neuromuscular disorder that weakens the skeletal muscles, especially those in the eyes, mouth, throat and limbs. The new monoclonal antibody treatment was approved for age 12 and up. After initial dosing, patients will receive maintenance doses every two weeks. Myasthenia gravis affects about 100,000 people in the U.S., according to J&J. Imaavy received an accelerated “priority review” of its application. With priority review, the FDA aims to take action on a drug application within 6 months, compared with 10 months under standard review.
J&J Press Release
Drug label for Immavy

Explanation of monoclonal antibody therapy from Cleveland Clinic.

Rinvoq (upadacitinib) extended-release tablets for Giant Cell Arteritis (GCA)

Abbvie’s rheumatoid arthritis, ulcerative colitis, and eczema drug Rinvoq received expanded approval to treat giant cell arteritis (GCA) in adults. GCA mainly affects women over the age of 50 and causes inflammation of the arteries in the scalp, neck, and arms. Giant cell arteritis often occurs along with polymyalgia rheumatica, a disorder causing muscle pain and stiffness in the neck, shoulders and hips.

Adverse reactions when taking Rinvoq for GCA include upper respiratory tract infections, headache, fatigue, swelling (edema), cough, anemia, rash, herpes zoster (shingles), and nausea. Rinvoq’s website says it is the first and only once-daily, non-steroid pill approved for the treatment of GCA. Rinvoq was originally approved in 2019.
Rinvoq press release
Rinvoq Drug Label with Expanded Approval
Read more about giant cell arteritis (GCA) at Medline Plus.

Research: Potential of Amlodipine for ADHD

An international team of researchers, including scientists from University of Iceland and University of Surrey, found that a common blood pressure drug, amlodipine, could be an effective new ADHD treatment. The study, which involved testing the drug on rats and zebrafish, was published in Nature’s Neuropsychopharmacology journal.
https://www.psychiatrist.com/news/blood-pressure-drug-could-offer-novel-adhd-treatment/

Check out a list of amlodipine-containing calcium channel blocker drugs (used primarily for high blood pressure) and their ratings at Ask a Patient: Amlodipine-containing Medications

Medication Tips

Dr. Lucy McBride answered these recent health and medication questions asked by readers of her newsletter “Are You Okay?”

• Is it possible to eat too much protein?

• Is it safe to stay on a GLP-1 forever?

• How can I safely transition off of a GLP-1?

• I had a high fasting blood sugar—should I be worried about diabetes?

• What can I do about low blood pressure?

  ---

Did you miss the last Drug Safety Update? Check out:
Warnings about Topical Finasteride
Counterfeit Ozempic Warnings

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

On April 10, 2025, FDA commissioner Martin Makary announced that the FDA has a plan to encourage the use of New Approach Methodologies (NAMs), such as AI-driven computational models, organoids, and organ-on-a-chip systems for Investigational New Drug Applications (INDs) for safety testing and will no longer mandate animal testing in “preclinical” (before human clinical trials) safety studies.

The agency will also begin using pre-existing, real-world safety data from other countries with regulatory agencies similar to the FDA. The plan was outlined in a roadmap, with an initial focus on encouraging NAMs for monoclonal antibody therapies, and eventually expanding the use of NAMs for all types of drugs.

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs: Press release by Martin Makary, April 10, 2025
The press release includes the “Key Benefits of Replacing Animal Testing in Monoclonal Antibody Safety.”

The roadmap (11 pages): FDA Roadmap for New Safety Testing Methods

Explanation of monoclonal antibody therapy at Cleveland Clinic.

Mixed Reactions to Animal Testing Announcement

Reactions from the public, medical, and research communities are mixed. The Regulatory Affairs Professionals Society (RAPS) reports that The People for the Ethical Treatment of Animals (PETA), the Animal Wellness Action, and the Physicians Committee for Responsible Medicine have all expressed support for the change. On the other hand, The National Association for Biomedical Research (NABR) said in a press release that there is “no full replacement” for animal models in drug development and biomedical research.

Tyler Vandivort, associate director and regulatory lead at UCB Biopharma, said the actions are “well aligned with recent steps” taken by other regulatory entities such as the Environmental Protection Agency and European Medicines Agency.

RAPS: FDA seeks to reduce animal testing requirements for mAbs, other drugs

Dr. Irving Kent Loh, a preventive cardiologist and the director of the Ventura Heart Institute in Thousand Oaks, says caution is needed. He expressed his concerns about the FDA’s plan in a USA Today opinion column:
USA Today: Caution needed before phasing out animal testing of new medications

What do you think? Is this a good move by the FDA? Answer our opinion poll:

The next regular issue of Ask a Patient® Health News: Drugs & Treatments is scheduled for Sunday, May 4 (the newsletter was on break Sunday, April 20). Today’s post contains an important notification about recent delays in FDA reporting, which could result in temporary changes to the types of alerts covered in this newsletter.

So far this month (April 2025), the FDA has not updated its database containing drug safety-related label revisions. While delays in reporting have happened before, this is an unprecedented amount of time to go without safety updates. The database is one of the primary sources of information for this newsletter.

The FDA’s REMS data files page has not been updated so far this month (April 2025), which is also unusual. REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines with serious safety concerns, such as drugs that may cause birth defects or pose extreme risk to a patient if not taken strictly according to instruction. In February, we noted that the repository was missing from the FDA website. It was restored after more than a week.

FDA continues to release important recalls and warnings notices. Here are three recent FDA press releases that warn consumers not to use certain drug products on the market:

Warning About Topical Finasteride for Hair Loss

The FDA warns consumers, health care providers, and compounders about potential risks from compounded topical finasteride-containing treatments for male hair loss. The products are sold as spray formulations through telehealth platforms like Roman, Keeps, and Hims & Hers. The online products are available as a finasteride-only treatments or are compounded into a mixture of finasteride and minoxidil (ingredient used in brand name hair loss treatment Rogaine) and sometimes also include tretinoin (ingredient used in the skin treatment Retin-A).

Users have reported side effects including depression, fatigue, insomnia, dizziness, and low libido. These are side effects similar to those associated with the approved finasteride prescription tablets. The telehealth websites falsely suggest that because the drug is sprayed directly onto the scalp, it will have fewer side effects than oral tablets.

Finasteride is a prescription ingredient approved to treat hair loss in men (Propecia tablets) and to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate (Proscar tablets). No topical versions are FDA-approved.

The FDA notes that the topical formulation, which through skin contact could be transferred to others, could be especially dangerous to pregnant women because of the potential to cause abnormalities of a male fetus.
FDA Press Release on Topical Finasteride

Dietary Supplements Painflex Forte and Artrifan King Contain Hidden Ingredients

The Food and Drug Administration warns consumers not to purchase or use Painflex Forte, or Artrifan King, products promoted and sold as treatments for arthritis or joint pain. These products are sold as supplements on various websites, including Amazon, ibspot.com and possibly in some retail stores.

An FDA laboratory analysis found that Painflex Forte and Artrifan King contain active drug ingredients not identified on the label: dexamethasone (corticosteroid) and diclofenac (non-steroidal anti-inflammatory drug (NSAIDs). In addition, Artrifan King was found to contain methocarbamol (a muscle relaxant). These ingredients can cause severe side effects. Read press releases for complete details and product images:
FDA Press Release on Painflex Forte
FDA Press Release on Artrifan King

FDA List of Pain and Arthritis Products Containing Hidden Ingredients

FDA Warns Consumers and Pharmacies about Counterfeit Ozempic

Consumers and retailers are warned about counterfeit Ozempic, some of which has been taken off the market. Retail pharmacies are advised to purchase authentic Ozempic and other semaglutide-containing medicines only through authorized distributors of Novo Nordisk.

Patients are encouraged to only use authentic Novo Nordisk Ozempic (semaglutide) injection obtained through pharmacies and to check the product for any signs of counterfeiting before using. Seized counterfeit products feature lot number PAR0362 and illegitimate serial numbers beginning with the first eight digits 51746517. Lot number PAR0362 is an authentic lot number. Only when both the lot number is coupled with the eight digits 51746517, it is counterfeit and should not be used. Check press release for more information and product images.
FDA Press Release on Counterfeit Ozempic

Novo Nordisk Press Release

The FDA is warning consumers not to use certain over-the-counter topical analgesic creams, gels, and sprays that are being illegally marketed to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. These products have higher concentrations of lidocaine than are allowed in over-the-counter lidocaine products, which could lead to serious injury. Some of the products contain added drugs like epinephrine which could be dangerous. Check the six companies, associated products, and websites where the products are sold.
https://www.askapatient.com/news/lidocaine-topical-drugs-new-warnings.asp

Migraine Headache Drugs: New Side Effects

Reports of two additional adverse effects were added to the labels of six drugs that prevent and/or treat migraine headaches. High blood pressure and risk of Raynaud’s Phenomenon (a type of circulation problem) have been reported for: Aimovig, Qulipta, Ajovy, Ubrelvy, Zapzet, and Emgality, and Nurtec ODT.
New Warnings for Migraine Headaches Drugs - Ask a Patient

Imfinzi (durvalumab) for intravenous infusion

Imfinzi is an immunotherapy that treats different kinds of cancer, including NSCLC (non-small cell lung cancer), small cell lung cancer (SCLC), liver cancer and endometrial cancer. Its safety label was updated to include clinical trials results and updated side effects for its recent approval for muscle invasive bladder cancer (MIBC), a type of cancer that has spread into the muscle layer of the bladder but not to other parts of the body.

The most common side effects when used for MIBC include low red blood cells (anemia), low white blood cells, constipation, increased level of creatinine in the blood, decreased level of magnesium in the blood, decreased appetite, nausea, and more. See label update for complete details. Imfinizi was approved in 2017.
Imfinzi FDA Safety Label Change

FDA issued a press release about Imfinzi's new approval for bladder cancer.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use

Prostate cancer drug Pluvicto received expanded approval to treat metastatic castration-resistant prostate cancer (mCRPC). Pluvicto may now be used by adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy (such as enzalutamide or Xtandi brand name), but not necessarily chemotherapy. Previously, patients were required to have already tried both kinds of treatments in order to be eligible to be screened for Pluvicto.

Patients are screened using a companion PSMA positron emission tomography (PET) scan (such as Locametz) that measures PSMA expression in tumors. The drug label was updated with clinical trials data that support the expanded approval. The number of patients eligible for the treatment is expected to triple with this expanded approval.

The revised label provides additional warnings about the risk of myelosuppression (decrease in the production of blood cells) and renal toxicity (kidney injury). Patients are advised to remain well hydrated and to urinate frequently. Healthcare providers should perform kidney function laboratory tests and monitor complete blood counts. Pluvicto was approved in 2022.
Pluvicto FDA Safety Label Change

FDA issued a Press Release about Pluvicto’s expanded approval for prostate cancer.

Read more about Pluvicto, a unique “radiopharmaceutical” that delivers radiation directly to tumors without affecting surrounding cells, in our post from last year that includes comments from radiation oncologist Dr. Stacy Wentworth (writer of the newsletter Cancer Culture).
https://news.askapatient.com/i/144784960/radiation-oncology-promising-treatments

Check out this information from the Prostate Cancer Foundation that answers the question: “I have metastatic castrate-resistant prostate cancer (mCRPC). Could I benefit from PSMA-targeted radioligand therapy?”
https://www.pcf.org/c/will-psma-targeting-radioligand-therapy-be-helpful-for-me/

Tymlos (abaloparatide) injection, for subcutaneous use

Osteoporosis drug Tymlos had a label change to warn about post-marketing reports of patients experiencing increases in blood pressure. Tymlos was approved in 2017.
Tymlos FDA Safety Label Change

Drug Research: Antidepressants and Sudden Cardiac Death

A University of Copenhagen study presented at the European Society of Cardiology Congress (ERHA 2025) found that individuals with a history of antidepressant use have an increased risk of sudden cardiac death, which varies based on age and time of exposure, compared with individuals with no history of antidepressant use. The researchers define sudden cardiac death as “an unexpected death of a person, believed to be caused by a heart-related issue… occurring within one hour of the onset of symptoms in witnessed cases or within 24 hours of the person being last seen alive in unwitnessed cases.”

The study analyzed health and death records for 4.3 million residents in Denmark aged 18-90 years for the year 2010. That year there were a total of 45,701 deaths and 6002 cases of sudden cardiac death. Of the 643,999 residents who had a recent history of antidepressant use, there were 1,981 sudden cardiac deaths. This compares with 4,021 sudden cardiac deaths among people without a history of antidepressant use. The incidence rate ratio of sudden cardiac death was significantly higher for antidepressant users across all age groups except for the age group 18-29 years, for whom the association was not statistically significant.

Researchers also found a greater risk of sudden cardiac death for individuals taking antidepressants for longer periods of time. When the data was adjusted for age, sex and comorbidities, the group exposed to antidepressants for 1 to 5 years had a 56% higher risk of sudden cardiac death, while those exposed to antidepressants for six or more years experienced a 2.2 times higher risk.

Note: Specific antidepressants used by individuals were not identified in the study. Also, the researchers acknowledge that having a psychiatric disorder is independently associated with sudden cardiac death. Patients with schizophrenic disease have the highest rates of sudden cardiac death.
Press Release: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Use-of-antidepressant-medication-linked-to-substantial-increase-in-risk-of-sudden-cardiac-death

Study: Mujkanovic, J., Warming, P. E., Kessing, L. V., Køber, L. V., Winkel, B. G., Lynge, T. H., & Tfelt-Hansen, J. (2024). Nationwide burden of sudden cardiac death among patients with a psychiatric disorder. Heart, 110(23), 1365–1371.

Supplements Tips: Green Tea and Vitamin B-12

Green Tea Bags and Microplastics

While many people drink green tea for its health benefits, some consumers may unknowingly be ingesting microplastics along with the tea. Nylon or plastic-containing tea bags can release billions of microplastics particles into each cup of steeped tea, according to independent testing laboratory Consumer Lab. They surveyed makers of bagged green tea and found that brands containing plastic include Kirkland (Costco) and Trader Joes, who reported using a very small amount of “acrylic binder and PAE (Poly-Amide-Epichlorohydrin).”

Tetley brand tea bags are compostable but may be heat sealed, meaning that they may contain a very small amount of plastic, according to Consumer Labs. Twinings reported that its enveloped tea bags are made from tea paper (wood pulp) and are folded and tied with string. Additional companies that state they do not use any plastic in their teabags include Yogi, Stash, and Tazo. Lipton and Celestial Seasonings brands have not yet responded to the survey. An option to avoid microplastics is to steep loose tea with a metal tea ball.
Consumer Lab: Green Tea Review: Tea Bags, Loose Leaf Tea, Matcha Powders, and Supplements
(article is paywalled; membership required to view; this article also includes test results for levels of heavy metals, caffeine, antioxidants, and green tea polyphenols.)

Vitamin B-12 Supplements Sold on Amazon Fail Potency Testing

Natural products company NOW Foods tested 25 different brand samples of Methyl B-12 (Vitamin B-12) purchased on Amazon in January 2025. These included liquids, lozenges, and tablets. Since Vitamin B-12 is found in meat, poultry, fish, and dairy products, not plant-based foods, these supplements are often taken by vegetarians. Test results showed 11 brands exceeded their label claim for the vitamin, with six testing over 120%. 12 brands tested below 100%, with three showing potency between 90-100%, while three brands contained only 0-1% potency.

An example of a brand with 0% potency was a 90-tablet bottle from Nextdia, CA. Check link below for a description of testing methodology and a table with results by brand name. Brands that failed potency testing are marked with the symbol ⚠︎ . NOW says it reported the results to both Amazon and the FDA.
https://www.nowfoods.com/healthy-living/articles/nows-testing-methyl-b-12-brands-amazon

Why do you need Vitamin B-12?

“Vitamin B-12 (cobalamin) plays an essential role in red blood cell formation, cell metabolism, nerve function and the production of DNA, the molecules inside cells that carry genetic information. Left untreated, a vitamin B-12 deficiency can lead to anemia, fatigue, muscle weakness, intestinal problems, nerve damage and mood disturbances.”
(from MayoClinic)

Thank you for reading this edition of Ask a Patient® Health News: Drugs & Treatments. We will not be publishing an edition on Sunday, April 20; check the newsletter’s “Notes” column for important safety updates that we may post in the meantime.

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

Please visit our website at www.askapatient.com for consumer-submitted ratings and reviews of medications and some vaccines. Please refer our website and newsletter to a friend or colleague: