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

Tec-Dara Approved for Multiple Myeloma; Third Priority Review Voucher Approval

FDA approved Janssen’s Tec-Dara, (a combination of teclistamab and daratumumab hyaluronidase-fihj), to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Myeloma is a rare blood cancer that affects the blood plasma. In the supporting study, Tec-Dara reduced the risk of disease progression or death by 83% relative to the standard of care control arm. Because of the promising results, FDA proactively awarded Tec-Dara a priority review voucher in December 2025.

This is the third FDA approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. The program aims to speed up the approval time for drug applications that address critical national health priorities. Both drugs in the Tec-Dara combination had prior individual approval.
FDA Press Release, March 5: FDA-grants-third-approval-under-national-priority-voucher-program

First Two Priority Review Voucher Approvals: Lung Cancer Treatment and Amoxicillin Antibiotic

The first two approvals under the CNPV program were Boehringer Ingelheim’s non-small cell lung cancer drug Hernexeos (zongertinib) and Augmentin XR (amoxicillin; clavulanate potassium), an antibiotic which had been discontinued in 2011 but was relaunched by USAntibiotics and is made in the U.S. The swift approval of Augmentin XR aimed to address antibiotic shortages and enhance domestic drug production.

Changes to Prescribing Guidelines for Antibiotics for Sinus Infections

More news about amoxicillin antibiotic (Augmentin brand name): A new clinical protocol released by the American Academy of Otolaryngology-Head and Neck Surgery now advises a “wait and see” approach before prescribing antibiotics for many sinus infections. And if a drug is prescribed, the “go-to” is Amoxicillin, with or without clavulanate potassium, for 5 – 7 days. Check out this assessment of the new recommendation at Doc’s Lounge:
We Prescribe Antibiotics for Sinusitis More Than Almost Anything Else. The Guidelines Just Got Stricter

Pediatric Approval for PKU Treatment Palynziq (pegvaliase-pqpz)

The FDA expanded approval of BioMarin’s Palynziq (pegvaliase-pqpz) to include children 12 years of age and older with phenylketonuria (PKU), a rare genetic amino acid metabolism disorder in which the body can’t properly break down phenylalanine, a substance in almost all foods. PKU can cause seizures and intellectual disability if not controlled at a young age. All newborns in the U.S. are tested for PKU with a heel prick (blood sample). If they are found to have the condition, the babies will drink a special formula and will also have a special low-protein diet for the rest of their life. The PKU diet consists of avoiding meat, dairy, nuts, beans, tofu, and other foods that are high in protein.

Palynziq, originally approved in 2018, is a prescription enzyme therapy self-administered daily (after a weekly initiation regimen) using a subcutaneous prefilled syringe. It works by lowering blood levels of phenylalanine and makes dietary control easier for some patients. Patients taking it may be able to eat foods that they previously had to avoid, but will always need to monitor their diet.

Palynziq can cause serious allergic reactions and has a boxed warning for the risk of anaphylaxis. In a study of 36 patients age 12 to 17, anaphylaxis was reported in about 11% of Palynziq-treated patients. Epinephrine must always be available to the patient to counteract potential allergic reactions.

Another newly added warning for Palynziq is that levels of Phe have gone too low during treatment, a condition called Hypophenylalaninemia. Health care providers must monitor blood Phe levels periodically during treatment. This side effect was noticed in clinical trials. For the trial (“Study 4”) of patients age 12 to 17, 28% of patients in the PALYNZIQ-treated group experienced hypophenylalaninemia, compared to 5% of patients in the diet-only group.

BioMarin is also seeking approval from the European Medicines Agency to expand the use of Palynziq to include adolescents age 12 and up.
FDA Palynziq Safety Label Update
BioMarin Press Release: FDA approves-biomarins-palynziq-pegvaliase-pqpz-for-adolescents-12-years-of-age-and-older-with-phenylketonuria-pku
Read more about PKU disease at Medline Plus.
The only other prescription drug treatment for PKU is Kuvan (sapropterin dihydrochloride) tablets, approved in 2007

Research: Study Warns of Dangerous Flaws in ChatGPT Health AI

Within weeks of ChatGPT Health’s release in January 2026, OpenAI reported that about 40 million people were using the tool daily to seek health information and guidance, including advice about whether to seek urgent or emergency care. However, investigators of a new study say there was little independent evidence about how safe or reliable its advice actually was.

Researchers at Mount Sinai Health’s Icahn School of Medicine found that ChatGPT Health has considerable and potentially dangerous flaws, as the tool under-estimated the severity of various medical situations half of the time. In the study, researchers fed 60 medical scenarios to ChatGPT Health. The chatbot’s responses were compared with the responses of three physicians who also reviewed the scenarios and triaged each one based on medical guidelines and clinical expertise.

In cases like impending respiratory failure, the bot seemed to be “waiting for the emergency to become undeniable” before recommending the ER, for example. Compared with the doctors in the study, the bot also over-triaged 64.8% of nonurgent cases, recommending a doctor’s appointment when it wasn’t necessary. The research team plans to continue evaluating updated versions of ChatGPT Health and other consumer-facing AI tools, expanding future research into areas such as pediatric care, medication safety, and non-English-language use. The study was published in Nature Medicine.
NBC: Chat GPT Health Under-triaged Half of Health Emergencies
Mount Sinai Press Release: Research-identifies-blind-spots-in-ai-medical-triage

Research: GLP-1 Pills for Diabetes and Weight Loss Compared

An Eli Lilly-sponsored trial involving 1,698 participants found that Eli Lilly’s experimental GLP-1 pill, orforglipron, worked better than the Rybelsus tablet (semaglutide) for people with type 2 diabetes. Over a year, those who took daily orforglipron had lower blood sugar levels and lost around 20 pounds on average, compared to about 11 pounds lost with daily Rybelsus tablets. However, side effects like nausea and stomach issues were more severe with orforglipron: more people stopped taking orforglipron than semaglutide because of side effects. Lilly says the comparison used the regular diabetes doses of Rybelsus, not the stronger doses of semaglutide in Novo Nordisk’s newer weight-loss pill (Wegovy), because at the time the trial began, the Wegovy pill had not yet been approved. The study was published in The Lancet.

Scientific American: Head-to-head-trial-shows-eli-lillys-oral-GLP-1-orforglipron-outperforms-oral version of Ozempic (Rybelsus)
Novo Nordisk has three approved GLP-1 pills:
(see our article “Rybelsus Tablets Rebranded as Ozempic Tablets” and “Wegovy Tablets” approval in December 2025)

Related Research Summary at Ask a Patient Health News: Research-stopping-GLP-1-weight-loss-drugs-leads-to-faster-weight-regain-than-discontinuing-behavioral-weight-loss-program

Warning from PAHO about Inappropriate GLP-1 Medication Use

The Pan American Health Organization (PAHO) urged the 35 countries in the Region of the Americas to strengthen monitoring and ensure the appropriate use of glucagon-like peptide-1 receptor agonist (GLP-1) medicines, in light of increasing reports of adverse events associated with their misuse. In an epidemiological alert published on February 27, PAHO warned that growing demand for these medicines may encourage their commercialization through unofficial channels, including the internet and social media, increasing the risk of exposure to falsified, unauthorized, or substandard quality products.
PAHO Press Release: PAHO-calls-for strengthened-pharmacovigilance-following-reports-of misuse of-GLP-1-medicines

FDA Warns Illegal GLP-1 Online Retailers and Pharmacies

Commercialization of the medicines through unofficial channels has already been realized and the problem is growing. This week, the FDA sent a second batch of 30 cease and desist warning letters to online retailers, compounding pharmacies, and telehealth companies for illegal production, sale, and marketing of compounded GLP-1 drug products, including semaglutide and tirzepatide.
FDA Press Release: FDA-warns-30-telehealth-companies-against-illegal-marketing-compounded-GLP-1s

Medication and Supplement Tips

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

GLP-1s and Potential Bone Loss

A 58-year old reader has been on semaglutide for eight months and lost 35 pounds. She’s happy to lose the weight but concerned about how the weight loss might affect her bone health.
Question-1-GLP-1s-and-bone-density

Asymptomatic Heart Problems

A 40-something reader is concerned about her heart health after a friend had a ‘widow maker’ heart attack in his 40s.
Question-2-screening-for-heart-attack

Heart Health

From Washington Post, “Should You Take a Supplement for Heart Health? Here’s What the Science Says” (not paywalled; from MSN)

Supplements to Take or Avoid while Taking GLP-1s

Independent testing company Consumer Lab reviewed which supplements and foods might be helpful or harmful for those taking GLP-1 medications.
Helpful: Protein, fiber, probiotics
Supplements to avoid or use with caution: High-dose turmeric/curcumin
Supplements that may reduce the effect of GLP-1 drugs: High-dose niacin, prescription digestive enzymes, CLA (conjugated linoleic acid) melatonin; krill oil. Desiccated thyroid may also interfere with blood sugar control.
Supplements that may intensify the effect of GLP-1s because they reduce blood sugar: Aloe vera, ashwagandha, chromium picolinate, cinnamon, ginseng

Supplements Claiming to Do the Same Thing as GLP-1s

Consumer Lab says that supplements that might make you feel full and eat less don’t work as well as GLP-1s because the action is very short-lived. The probiotic Akkermansia muciniphila and TUDCA (tauroursodeoxycholic acid), as well as the sugar substitute allulose, are marketed as increasing natural levels of GLP-1 and possibly improving weight loss. Berberine (known as “Nature’s Ozempic”) has a much smaller effect on blood sugar compared to GLP-1 drugs and has not been proven to cause significant weight loss. Consumers should beware of topical GLP-1 supplements (like patches and gels) which Consumer Lab says don’t work. Also, be cautious of Gymnema sylvestre, a woody vine-derived supplement that is marketed to lower blood sugar, because it has caused rare but severe allergic reactions.

Consumer Lab: Supplements to Take or Avoid When Using a GLP-1 Drug (full article requires subscription)

Did you miss our last edition? Find it here:

Asteria Health, a licensed compounding outsourcing pharmacy in Birmingham Alabama, is recalling more than 118,000 pellets of estradiol ranging in strength from 6 mg to 37.5 mg along with more than 600,000 testosterone pellets and testosterone-anastrozole combination pellets ranging in strength from 12.5 mg to 200 mg due to potential metal particle contamination. These pellets are administered subcutaneously (under the skin). Testosterone pellets treat testosterone deficiency or hypogonadism. Estradiol pellets, also a “bioidentical hormone replacement therapy, ” are often used for menopause symptoms. Asteria is part of Biote Health, a provider of hormone imbalance therapies for men and women.
FDA Recall Enforcement Report

Read more about hormone pellet therapy at Medical News Today: “Hormone Pellet Therapy for Menopause”

TV Commercials Flagged for False and Misleading Advertising

Sponsors of the following drugs recently received letters from the FDA warning that promotional communications, including direct-to-consumer advertisements for the drugs are “false or misleading” because they make false claims about clinical trials results and drug efficacy, omit important information, and/or present visuals that are misleading. These letters are sent from the FDA Office of Prescription Drug Promotion (OPDP).

• Tremfya (guselkumab) injection for plaque psoriasis: OPDP Letter

• Neffy (epinephrine) nasal spray for emergency allergic reactions including anaphylaxis: OPDP Letter
  Here is an example of concern cited by the FDA: actors in the commercial are shown pulling a bottle of Neffy out of a purse or other bag in order to demonstrate how compact and convenient the medication is. In reality, the patient guide clearly states that the medication must be kept in its blister pack until it is time to use the medication.

• Wegovy (semaglutide) for weight loss: OPDP Letter

• Vonjo (pacritinib) for a rare bone marrow cancer called myelofibrosis: OPDP Letter

Check here for a list of 103 FDA “untitled” letters for pharmaceutical products from the Office of Prescription Drug Promotion going back to 2018. The list can be sorted by product name, company name, and date of letter.

New Drug Approvals Will Require a Single Clinical Trial

FDA Commissioner Martin Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER) announced (in the New England Journal of Medicine) the FDA’s plan to require only one clinical trial (instead of two) to serve as the basis for approving new drugs. Although the two-trial requirement has been in effect since the 1960s, new types of approval paths, such as those for rare diseases, have gained at least temporary approval on the basis of just one trial.

Previous FDA Commissioner Janet Woodcock, who supports the change, said that more than half of drug approvals happening now are already based on just one trial. Previous FDA Commissioner Robert Califf also expressed his support of the new policy, stating that “the FDA will still retain discretion to require additional studies when warranted,” but says more detail is needed. Other former top FDA officials who spoke to RAPS Focus raised concerns about how the policy was developed and announced.
RAPS Focus: “Experts React to FDA Shift to Single Pivotal Trial for Most Drugs”
New England Journal of Medicine: “One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma” (requires subscription to view)

First Pancreatic Cancer Device Treatment

The FDA approved Novocure’s Optune Pax as the first of its kind device treatment for adults with locally advanced pancreatic cancer, to be used in conjunction with chemotherapy. The portable non-invasive device delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue. Oncologist Daniel Flora notes that although this is not a breakthrough treatment (only eight weeks of overall survival benefit), it is worth considering for a cancer type that has few available treatment options.

Novocure also makes products that work in a similar way for brain cancer (approved in 2015) and lung cancer (approved in 2024).
FDA Press Release: FDA approves-first-its-kind-device-treat-pancreatic-cancer

Fierce Biotech: “Novocure gets FDA nod for tumor-treating electric fields targeting pancreatic cancer

Keytruda Approved for Ovarian Cancer

The top-selling drug in the world with over $31 billion in sales, Keytruda was just approved for an additional cancer indication: ovarian cancer. It is also now available for subcutaneous injection as Keytruda QLEX. This chart from Senthil Ramanathan Ph.D. shows rankings of oncology drugs by worldwide revenue in billions.

FDA Press Release: “FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma”

If you have used Keytruda as a treatment for any illness, did it help? Please take a moment to add your experience (and/or rate it on a scale of 1 to 5).

Warnings Strengthened about TD Risk for Metoclopramide-Containing Drugs

Drug labels for metoclopramide-containing drugs including Reglan (metoclopramide hydrochloride tablets and metoclopramide hydrochloride injection) and Gimoti (metoclopramide hydrochloride nasal spray) have been revised to strengthen the warnings about the risk of developing tardive dyskinesia (TD), a movement disorder that is more likely to happen with long-term use. Metoclopramide, which was approved in 1979, added a black box warning about the risk of TD in 2009.

Reglan tablets are approved for diabetic gastroparesis (a delay in the movement of stomach contents) and short-term treatment of gastroesophageal reflux (GERD) in patients who don’t respond to conventional therapies. In its I.V. form, it is approved for the prevention of nausea for chemotherapy and after surgery. Gimoti nasal spray is approved for treating diabetic gastroparesis. Read the safety label update and corresponding revised labels for all the changes, which also affect generic versions of the medications.

Safety Label Update for Reglan injection (currently available as generic only)
Safety Label Update for Reglan tablets
Safety Label Update for Gimoti nasal spray

The Columbian: “Vancouver-woman-sues-legacy-health-kaiser-permanente-and-two-physicians-after-developing-involuntary-movement-disorder”
This article describes the experience of a woman who had taken Reglan for more than two years as a treatment for gastroparesis. She first experienced restless legs syndrome then later an irreversible form of tardive dyskinesia; the drug continued to be prescribed even when switching doctors, and she was unaware of the possible connection of her symptoms with the drug. Thousands have filed lawsuits or complaints against Reglan and other brands of metoclopramide because of these effects.

Reglan FDA Adverse Event Summary by Ask a Patient show muscle-related disorders (tardive dyskinesia, extrapyramidal disorder, and muscle rigidity) as the top three reported adverse effects for the over 19,000 reports including Reglan between 2004 and 2025. Among the 566 voluntary reports filed directly through the Medwatch system, tremor was the 7^th most commonly reported adverse effect.

For Gimoti, tremor is the 7^th most commonly reported adverse effect on the report with 33 reports of tremor within the 539 total reports received for Gimoti so far.
View or add patient reviews for brand name Reglan or generic or Gimoti at Ask a Patient.

Note that the FAERS database (FDA Adverse Event Reporting System) consist mostly of company-submitted reports, which are mandatory. Reports submitted by individuals (consumers, doctors, or pharmacists) are voluntary reports and are submitted through the “MedWatch” database and represent just a small (less than 5%) of all reports in the FAERS database. Access one-page highlights of FAERS and MedWatch reports for thousands of drugs at Ask a Patient website.

Poor Report Card for Psychiatric Drugs Innovation

A University of Chicago/Stanford study found that psychiatric drug development lags behind other medical fields in terms of novelty and clinical impact. Researchers investigated clinical utility, innovation, and other measures of helpfulness as rated by various international organizations and regulatory bodies for 22 psychiatric drugs approved between 2012 and 2024.

Of the 22 drugs, 7 (31.8%) were categorized as first-in-class, 2 (9.1%) were considered an advance-in-class, and 13 (59.1%) were considered addition to-class. Three drugs (13.6%) received FDA priority review, 1 (4.5%) was designated as an orphan drug, and 0 were included on the WHO’s Model List of Essential Medicines (see below for the list of WHO-included psychiatric drugs). For clinical utility, none of the drugs with data available data received a rating of “clinically helpful,” and 3/22 (13.6%) were rated “clinically not helpful. The study was published in the Journal of Clinical Psychiatry.
Journal of Clinical Psychiatry: “Innovation in Psychiatric Drug Development: A Quantitative Analysis of FDA-Approved Psychiatric Drugs, 2012–2024”

Ask a Patient: “Changes to the WHO 2025 Model List of Essential Medicines for Mental and Behavioral Disorders”

Landmark PBM Reform Legislation and FTC Settlement: Good News for Consumers and Community Pharmacies

New federal laws combined with stepped-up Federal Trade Commission enforcement (such as the recent settlement with Cigna) of the PBM industry could mark 2026 as “the year of PBM reform.” Congress and the FTC are putting an end to the tactics used by PBMs to continue their rebate-hoarding practices, which included setting up skeleton-crew revenue receiving operations (called “Group Purchasing Organizations”) in tax-sheltered countries like Switzerland. All of the required changes, plus changes still to come from unsettled FTC action against CVS and United Healthcare, are good news for community pharmacies (independent pharmacies) and signal lower drug prices for consumers.

Investigative news organization Hunterbrook Media spent a year investigating the mysterious group purchasing organizations run behind the scenes by the big three PBMs (CVS, United Health, and Cigna). Hunterbrook’s investigative report “The Hidden Flow of Drug Money” was entered into the Congressional record in a recent hearing where the big three health insurance executives were questioned by lawmakers. Click on the link in the caption below to access the page with the interactive graphic that clearly explains the findings. “Drug manufacturers pay billions in discounts, rebates and fees to pharmacy benefit managers (PBMs). But where does that money actually go? Follow the flow.”

From Hunterbrook: “Our multinational investigation reveals how CVS, United Health, and Cigna created new subsidiaries to divert billions of dollars from health plans and patients. All three tried to keep it secret. None answered repeated questions. CVS sued to stop evidence getting out. Cigna called the police on a reporter.”
“The takeaway: PBM GPOs appear to generate astronomical revenue with skeleton staff — making Zinc (CVS), Emisar (United Health), and Ascent (Cigna) among the world’s most lucrative enterprises on paper, even though they appear barely to exist in the real world…”

Read about the recent FTC settlement with Cigna/Express Scripts PBM from HealthCare Uncovered: “In FTC Settlement, Cigna Agrees to Change Some PBM Business Practices, Charge Customers Less for Insulin”

Read about new legislation that has been signed into law from KFF News: “What to Know About Pharmacy-benefit-managers-pbms-and-federal-efforts-at-regulation”

The National Community Pharmacists Association (NCPA), which represents independent (not chain) pharmacies, applauds the recent PBM reform. “For years, our members and we have been telling anyone who will listen — and worked to convince others who wouldn’t listen — about the PBM-insurer conglomerates gobbling up market share, driving up drug costs, crushing small-business pharmacies, and making it more difficult for patients to receive the care they need. We’ve been warning that unless action is taken, more pharmacies will close, and more pharmacy deserts will grow. Unfortunately, as time passed, we were proven correct and finally, there is action to help reverse these trends.”
NCPA Cheers Trump Signs First Major PBM Reform in Decades

They also applaud the FTC action against Express Scripts:
NCPA Press Release: Boom! FTC Squeezes Concessions from Cigna’s Express Scripts

Did you miss the last edition from February 8? Find it here:

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:

The FDA Center for Veterinary Medicine granted full approval to Pegasus Laboratories’ KBroVet (potassium bromide chewable tablets), a prescription treatment for the control of seizures in dogs with idiopathic epilepsy, or recurring seizures with no known cause. Pegasus’ KBroVet website notes that idiopathic epilepsy is the most common chronic neurologic disorder in dogs. Dog owners must work closely with their veterinarians to monitor clinical signs of bromide intoxication, which can happen when high levels of bromide overwhelm the nervous system. The medication, which is taken daily, has been available under conditional approval since 2021.

FDA Press Release: FDA Grants Full Approval for Drug to Control Seizures in Dogs With Idiopathic Epilepsy

Drug Information for KBroVet The 15-page guide posted at the FDA website provides supporting clinical data, dosage instructions, and more.

While any dog breed can develop idiopathic epilepsy, Schnauzers, Collies, Basset Hounds, Cocker Spaniels, Labrador Retrievers, and Golden Retrievers are diagnosed more frequently. Read more about idiopathic epilepsy in dogs at Whole Dog Journal: “Managing Idiopathic Epilepsy”

New Drug Treats Lymphoma in Dogs

The FDA Center for Veterinary Medicine granted full approval for Anivive Lifesciences’ Laverdia (verdinexor) tablets to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia prevents certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs. The medication has been available under conditional approval since 2021. Owners of dogs with lymphoma administer Laverdia orally while at home, following a veterinarian prescription and the safety directions detailed in the product’s client information sheet. Laverdia is given twice per week immediately after eating, with at least 72 hours between doses. The most common adverse effects are anorexia, weight loss, vomiting, diarrhea, and lethargy.

Medical gloves safe for use with chemotherapy drugs should always be worn when handling Laverdia and when cleaning up after a dog undergoing treatment and for three days following the last treatment. The FDA states that canine lymphoma affects fewer than 80,000 dogs in the U.S. each year.

FDA Press Release: FDA Grants Full Approval of First Oral Treatment for Lymphoma in Dogs

Minoxidil Warning for Pet Owners

If you have a dog or cat and also use minoxidil (including Rogaine brand name) as a hair loss treatment, be careful not to let your pets ingest the medication or come in contact with surfaces that may have been exposed, such as skin, towels, clothes, and bedding. The FDA recently posted updates to minoxidil labels to include a new pet-related warning after recent research has shown a link between minoxidil and toxicosis, with about 14% of hospitalized cats dying from the exposure

A medical literature review study led by Department of Dermatology and Skin Science, University of British Columbia, Vancouver was published in The Journal of the American Academy of Dermatology in August 2025: “Minoxidil toxicosis in cats and dogs: A scoping review and call to action.”

The study notes that symptoms, which include poor feeding and shortness of breath, may set in as early 30 minutes after exposure. Treatments mentioned in the study included supplemental oxygen, warming pads, intravenous fluids, diuretics, vasopressors, thoracocentesis (procedure to remove fluid or air from around the lungs), and beta blockers.

Longevity Pill for Dogs: Huge Clinical Trial to Begin

Veterinary drug research company Loyal announced that the FDA’s Center for Veterinary Medicine has accepted the Target Animal Safety (TAS) section of its “Expanded Conditional Approval” application for LOY-002, an investigational medication that aims to extend the lifespan of dogs. There are three components to the FDA’s “Expanded Conditional Approval (XCA)” process, and so far Loyal says it has met two of them: safety and efficacy.

Now it is working on the manufacturing component and beginning a clinical trial (called the STAY study) necessary for eventual full approval of LOY-002. Loyal says that the medication works by addressing the “metabolic dysfunction that all dogs experience as they age, delaying the start of many diseases that reduce quality of life for senior dogs.” So far, effectiveness data has not been released.

The STAY study is a double-blinded, four-year long placebo-controlled study with 1,300 dogs enrolled across 70 veterinary clinics nationwide. According to Forbes, this is the largest animal clinical trial ever conducted. LOY-002 is administered orally and is intended for dogs age 10 or older weighing at least 14 pounds. Loyal is also working on a separate injectable drug for very large dogs.

Loyal Press Release: One step closer to a longevity drug: LOY-002 hits key FDA milestone

Forbes: A Longer Leash on Life: Inside the Dog Longevity Startup Loyal
Profiles the founder of Loyal, 30-year-olld Celine Halioua who has raised more than $135 million in equity and has for years been focused on finding a marketable drug to improve longevity in dogs.

Other Longevity Research: Whole Dog Journal: “Rapamycin: the new anti-aging pill for dogs?”

Thank you for reading this special post about pet medications. Would you like to read more about pet medications news in the future? Please comment or click the “like” button on this page.

Reuters reports that Novo Nordisk’s new Wegovy (semaglutide) pill is a hit, with total prescriptions filled during its first full week on the market topping 18,000. This compares with only about 1,000 prescriptions filled for the traditional pen injection formulation of Wegovy. Eli Lilly recently received approval for the multi-dose vial formulations of Zepbound (tirzepatide) and Mounjaro (tirzepatide). This is the first time the brand name (not compounded) GLP-1 formulations are available in multi-dose vials. Check the Reuters link below for a graph showing share of prescriptions for Wegovy pill, Wegovy pen, Zepbound pen, and Zepbound vials. Wegovy once-daily pill formulation was approved in December 2025; it costs less than the pen, with a price as low as $25 with insurance or $149 (depending on dose strength) without insurance.
Reuters: Tracking Wegovy Pill Prescriptions First Week of Launch
ABC News: Wegovy Daily Pill Costs
Dr. Lucy McBride: Are GLP-1 Pills as Good as the Shots? What’s Missing from the Debate

Lilly’s GLP-1 Orforglipron Weight Loss Pill

Eli Lilly is working on its own GLP-1 weight loss pill and expects its orforglipron pill to receive FDA approval for obesity by April. The medication is fast tracked for approval, having received an FDA priority review voucher in November 2025. The pills will be less expensive than Lilly’s Mounjaro or Zepbound pens; according to Lilly’s press release, LillyDirect* will charge $149 for the lowest dose and higher doses will cost up to $399. While Novo’s Wegovy pill needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking or taking other medications, Lilly says its pill has no such restrictions. Orforglipron’s application as a type 2 diabetes treatment will be filed with the FDA later this year.
Lilly press release: What to know about orforglipron
Kelo (Thomson Reuters) Lilly Confident in Weight Loss Pill Supply

*It is a controversial and emerging trend for pharma companies to both make and prescribe their own medications.

Expanded Approval for Long-Lasting Birth Control Implant

Organon’s Nexplanon (etonogestrel), a rod-shaped contraceptive device that is implanted just under the skin in the upper arm, received FDA approval that allows for extending its use for up to five-years instead of just three. The label was updated with clinical trials data that supporting its effectiveness and safety for the longer period of use. The label also has a new Risk Evaluation and Mitigation Strategy (REMS) program that aims to mitigate the risk of complications (such as infection, bleeding, pain) due to improper insertion and removal of the device. The REMS requires that healthcare providers receive training and certification. The Nexplanon FAERS Report Summary at AskaPatient lists more than 5,000 device-related complication issues, including more than 2,000 reports of device dislocation (most reports submitted by Organon). Site-specific procedural complications of Nexplanon were identified in the FDA’s “Potential Signs of Serious Risk Identified by the FDA Adverse Event Reporting System (FAERS)” for October-December 2024.

Etonogestrel is a progestin-only ingredient that prevents pregnancy by preventing ovulation. Nexplanon was launched in 2010 with improved safety features (such as preloaded applicator and ability to be seen on X-rays) and was originally approved as the brand Implanon in 2001.

Contemporary OB-GYN: FDA approves-5-year-use-for-etonogestrel-implant-68-mg-contraceptive
Safety Labeling Update for Nexplanon

Patient Experiences with Nexplanon
Summary of MedWatch Voluntary Reports for Nexplanon (240 reports of device complications for 1,577 reports submitted voluntarily, mainly by consumers)

Rare Disease: FDA Approves First Treatment for Children With Menkes Disease

The FDA approved the first-ever treatment for Menkes disease: Zydus Life Sciences’ Zycubo (copper histidinate) daily subcutaneous injection for pediatric patients. Menkes disease is a neurodegenerative disorder affecting boys, caused by a X-linked genetic defect that impairs a child’s ability to absorb dietary copper. The medication serves as a way to replace the copper without having it go through the gastrointestinal tract. In clinical trials, the results were impressive: a median survival rate of 177.1 months for the early treatment Zycubo cohort compared with only 17.6 months for the untreated external cohort.

Symptoms of Menkes include sparse and de-pigmented hair, seizures and developmental delays. If left untreated, many patients die between ⁠the ages of two and three years. The disease prevalence ranges from 1 in 34,810 ‌to ‌as high as 1 in 8,664 live male births.
FDA Press Release on First Treatment for Menkes Disease

Rare Disease: FDA Expands Treatment Approval for Gaucher Disease

The FDA expanded the approval of Sanofi’s Cerezyme (imiglucerase) intravenous infusion enzyme replacement therapy to treat non-neurological symptoms in patients with Type 3 Gaucher disease, which is the rarest and most serious type. Previously it had only been approved for Type 1, which is the most common form and does not cause neurological symptoms. Gaucher, a rare disease affecting about one in every 50,000 people in the world population and up to one in 500 people in people of Ashkenazi (eastern and central European) Jewish heritage. It is caused by genetic mutations that lead to a deficiency of the glucocerebrosidase (GCase) enzyme.

Symptoms including enlarged organs, blood abnormalities, and bone disease. Those with type 3 also experience neurological complications. Cerezyme is also now approved for all ages, from birth and up. Cerezyme was originally approved in 1994. A label was updated with new safety warnings about hypersensitivity reactions and recommends infusion dosage modifications based on these infusion-related reactions.

FDA Cerezyme Updated Label and Safety Information
Read more about Gaucher Disease at Medline Plus.
Gaucher Disease News: Cerezyme Becomes First FDA-Approved Therapy for Type 3 Gaucher Disease

New Treatment for Progressive Pulmonary Fibrosis Lung Disease

The FDA approved Boehringer Ingelheim’s Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). Jascayd was previously approved to treat idiopathic pulmonary fibrosis (IFP) in adults. PPF is a chronic disease characterized by gradual, irreversible scarring of the lungs, which can lead to progressive breathing difficulties. PPF is an umbrella term that can describe progressive lung scarring in many interstitial lung diseases.
FDA Press Release on Jascayd

Converting More Prescription Drugs to Nonprescription Drugs

The two most recent prescription drugs to become available over-the-counter (OTC) in the U.S. were the O-pill (norgestrel) oral contraceptive and Narcan (naloxone) opioid overdose nasal spray, which both were approved for OTC in 2023. FDA Chair Marty Makary would like to see more prescription medicines available over-the-counter (or without a prescription).

A new rule that went into effect in May 2025 could help make this happen by creating an “additional condition for nonprescription use” protocol, which means that a person may need to consult with a pharmacist or answer questions on an automated telephone system or an app before being allowed to purchase a medication. In the United States, drugs are classified as either “Over-the-counter” or “Prescription only,” but that is not the case in other parts of the world, where there may be three or more approval types for access to medications.

Forbes: Trump Administration Says it Wants More OTC Meds But So Far No Action

What do you think? Should new categories of prescription drugs be made available to purchase in the U.S. without a prescription? If so, do you have a suggestion for a medication that would be a good candidate to make the switch? If so, add it to the comment box before clicking “Vote.” We’ll share the suggested answers in a future newsletter. Link to the poll here.

PPI Medications (like Omeprazole) and Research on Adverse Effects

Researchers at Sweden’s Karolinska Institute and other institutions in Denmark, Finland, Iceland, and Norway found no association between long-term proton pump inhibitor (PPI) use and stomach cancer. Previously, other studies suggested there was an association. PPIs are drugs taken for GERD (gastro-esophageal reflux disease) like omeprazole (Prilosec brand name), esomeprazole (Nexium), and lansoprazole (Prevacid) that block the secretion of stomach acid. In the large population-based study, which utilized Nordic country health care registries, researchers adjusted the data to address earlier studies’ known weaknesses, such as the fact that many people beginning to get stomach cancer symptoms would begin to take PPIs, but that did not mean that the patients’ cancer was caused by the PPIs.

As the authors point out, long-term proton pump inhibitor use is connected to serious side effects and increases the risk of some other potentially serious conditions such as Clostridium difficile associated diarrhea, osteoporosis, and vitamin or electrolyte malabsorption. “This highlights the need to balance the benefits and disadvantages of such use and to regularly reassess the need for continued proton pump inhibitor treatment.”

The research was published in The British Medical Journal (BMJ). British Medical Journal: Long term use of proton pump inhibitors and risk of stomach cancer: population based case-control study in five Nordic countries

Serious Adverse Effects of PPIs

While the connection of PPIs to dementia or cognitive decline has also been discounted, omeprazole has been linked to kidney injury. In October 2023, we reported that AstraZeneca paid $425 million to settle lawsuits alleging that patients suffered kidney injuries while using the heartburn drugs esomeprazole (Nexium) or omeprazole (Prilosec).

Case Studies

Here are two case studies about adverse effects tied to omeprazole:

1. When a young doctor began craving strange smells and salty flavors, he self-diagnosed it as a form of pica, but it took more than a year to find and fix the root cause of his condition. A drug taken long-term to treat GERD was the culprit.
   Ask a Patient feature article: Strange Symptoms: Patient Case Study Involving Omeprazole

2. A man developed kidney issues after gastric bypass surgery/hiatal hernia surgery. This was found to be linked to the PPI (omeprazole) that was given as a prophylactic to PREVENT post-surgery ulcers. The patient developed high creatine levels and serious kidney injury during the weeks after surgery. The author concludes that prophylactic use of PPIs must be carefully considered and may not be worth the risk.
   Recent case study in Cureus (medical journal): A Case-of-omeprazole-associated-acute-interstitial-nephritis

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   Tips about Meds for GERD and heartburn

   Remember the Zantac (ranitidine) recalls that started in 2019 and led to the eventual discontinuation of all ranitidine products in the U.S. due to NDMA (cancer causing carcinogen) impurities? In November 2025, after a pause of more than five years, the FDA approved a reformulated version of H2 blocker ranitidine that addresses the shelf-life deficiencies and impurities present in the previous versions. It is not known if the previous “Zantac” will be relaunched with ranitidine. Zantac 360 is available but it contains famotidine as its active ingredient.
   https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-reformulated-ranitidine-following-comprehensive-safety-review

   There are many options for heartburn relief. Check out the three categories described at our website:
   Antacid, H2 blocker, or PPI? Heartburn treatments in your kitchen, medicine cabinet, or at the drug store

   

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

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

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

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

SpecGx Oxycodone Recall

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

MediNatura Homeopathic Nasal Spray Recall Expands

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

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

Wegovy Recall

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

Rosuvastatin Recall

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Andexxa Withdrawn from the Market

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

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

Medication Tips: Blood Thinners

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

“Patients Walk a Dangerous Tightrope on Blood Thinners”

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

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Vist Ask a Patient Website

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

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

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

New Warning: Human Growth Hormone Drugs and Bone Problems

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

Read more about slipped capital femoral epiphysis at Medline Plus.

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

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

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

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

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

Drug Recalls Roundup

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

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

ReBoost Nasal Spray Recall

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

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

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

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

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

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

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

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

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

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

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

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

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

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Wishing all of our readers a Happy and Healthy Holiday!

In October, we reported that the FDA had awarded the first nine “priority vouchers” for drugs that will receive expedited approval decisions. The first drug on that list has already been approved: an antibiotic, Augmentin XR (amoxicillin-clavulanate potassium), received approval for a version to be produced in the U.S.
FDA Press Release: “First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity”
(Check out patient experiences with Augmentin XR , often used for sinus infections, on Ask a Patient.)

Also, the FDA announced a second batch of drugs receiving priority vouchers. These include a higher strength (7.2 mg) version of Novartis’ weight loss drug Wegovy (semaglutide). The higher strength version is also under review in the European Union and the U.K. Currently the maximum strength of Wegovy contains just 2.4 mg of semaglutide per injection.

The five additional drugs in the second batch include:
Zongertinib for HER2 lung cancer, Bedaquiline for drug-resistant tuberculosis in young children, Dostarlimab for rectal cancer, Casgevy for sickle cell disease, and Orforglipron for obesity and related health conditions.

FDA Press Release: FDA Awards Second Batch of National Priority Vouchers

New Sunscreen Ingredient Proposed

The FDA is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens. Right now, only zinc and titanium dioxide are approved as GRASE (Generally Recognized as Safe and Effective). This may not sound right, as sunscreens are still on the market that contain chemical ingredients like Avobenzone, Oxybenzone, and Octocrylene. A proposed order by the FDA in 2022 recommended not including these chemicals as Generally Recognized as Safe and Effective, because more safety data was needed, but that proposed order has not yet been finalized, and those chemicals are still allowed in over-the-counter sunscreens.

Based on data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. The ingredient is widely used in sunscreen products in other countries.

According to Dermatology Times, the proposal to add bemotrizinol was prompted by an “OTC Monograph Order Request” submitted by DSM Nutritional Products LLC, seeking authorization to use bemotrizinol at concentrations up to 6% in its over-the-counter sunscreen products. The American Academy of Dermatology (AAD), president Susan C. Taylor, MD, FAAD, “applauded the FDA for taking the first steps in more than 2 decades to provide more safe and effective sunscreen options to the American public.”²

FDA Press Release: “FDA Proposes Expanding Sunscreen Active Ingredient List”

Dermatology Times: FDA Proposes Expansion of US Sunscreen Ingredient Standards with Bemotrizinol

BEMT sunscreens may become available in summer or fall 2026 in the U.S., according to Today.

Two New “First in Class” Oral Antibiotics Approved for Gonorrhea

GlaxoSmithKline’s Blujepa (gepotidacin) tablets received expanded approval to treat uncomplicated gonorrhea (a sexually transmitted infection) in patients age 12 and up (weighing at least 99 pounds) who have limited treatment options. Blujepa is a first-in-class “triazaacenaphthylene” antibiotic, originally approved in March 2025 to treat urinary tract infections. The drug has a new warning about the risk of QTc Prolongation, or changes in electrical activity of your heart. Patients with a history of QTc interval prolongation, pre-existing cardiac disease, or patients taking antiarrhythmic agents should avoid taking the drug. Bluejepa has an FDA “clinical trials snapshot” available, which provides demographics (only women were in the trial) and outcomes for the first two clinical trials:
Clinical Trials Snapshot for Blujepa

The FDA also approved Entasis Therapeutics’ Nuzolvence (zoliflodacin) for uncomplicated gonorrhea in patients age 12 and up (weighing at least 77 pounds). The medication, a first-in-class “Spiropyrimidinetrione” antibiotic, consists of granules that dissolve in water. Uncomplicated gonorrhea infection is localized to the urethra or cervix and has not spread to other areas of the body. Left untreated, it could lead to widespread infection of the reproductive organs and infertility.

FDA Press Release: “FDA Approves Two Oral Therapies to Treat Gonorrhea”

New Drug for IgAN Kidney Disease

The FDA granted accelerated approval for Otsuka Pharmaceutical’s Voyxact (sibeprenlimab-szsi) subcutaneous injection to reduce proteinuria (protein in the urine) in adults with Immunoglobulin A nephropathy (IgAN) at risk for disease progression. IgAN is a kidney disease that causes protein to leak into the urine and may lead to kidney function decline. The disease is often diagnosed in young adults. As a condition of the accelerated approval, the ongoing trial must be completed to confirm that Voyxact slows kidney function decline over the long-term. The medication is administered by self-injection every four weeks.

FDA Press Release: FDA Approves New Treatment for Primary Immunoglobulin Nephropathy

Fierce Pharma: “In crowded kidney disease space, Otsuka receives FDA approval for first-in-class Voyxact”

New Gastric Cancer Treatment

Imfinzi (durvalumab) injection, for intravenous use, received expanded approval for treating gastric cancer and gastroesophageal cancer. Imfinzi is an immunotherapy that treats lung, bladder, and other types of cancers, often in conjunction with chemotherapy. It was originally approved in 2017.
FDA: FDA Letter of Approval
Imfinzi Revised Drug Label

New Lymphoma Approval for Breyanzi Cell Therapy

The FDA expanded the approval of Juno Therapeutics’ (Bristol Meyers Squibb) Breyanzi (lisocabtagene maraleucel) to treat adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a “CAR-T” cell therapy, a type of immunotherapy, that genetically engineers a patient’s own immune system’s T-cells to target and kill cancer cells.

Marginal zone lymphoma is a rare, slow-growing cancer of the lymphatic system. It represents about 7% of all B-cell non-Hodgkin lymphoma, with approximately 7,460 new cases diagnosed in the U.S. each year. Breyanzai was originally approved in 2021 to for prior treatment-resistant relapsed or refractory large B-cell lymphoma, a more common type of blood cancer that develops in white blood cells. Breyanzai is one of just 48 gene or cell therapies approved in the U.S.
FDA: Breyanzi Approval

Read more about B-cell lymphoma and Marginal Zone Lymphoma at Cleveland Clinic.

Cellular Therapy for Severe Aplastic Anemia

Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) received approval to treat Severe Aplastic Anemia, a rare condition where the bone marrow fails to produce sufficient blood cells, including red cells, white cells, and platelets. Stem cells become damaged, often due to the immune system attacking them.
FDA Press Release: FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

Nonprofit Drug Developer Receives FDA Approval for Wiskott-Aldrich Syndrome Treatment

Fondazione Telethon ETS’s Waskyra (etuvetidigene autotemcel) was approved as the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). WAS is an inherited (X-linked) immunodeficiency disease that affects about one in every 250,000 males and is characterized by bleeding, eczema, recurrent infections, and susceptibility to blood-related cancers. Waskyra treatment consists of the patient’s own blood stem cells, which have been genetically modified to include corrected copies of the WAS gene. Without treatment, many boys with WAS have a life expectancy of only nine to fourteen years. Patients successfully treated with bone marrow transplants (previously the only treatment available) have gone on to lead normal lives, but often a suitable donor cannot be found, according to the Wiskott-Aldrich Foundation. The FDA notes that this is this is a first approved cell and gene therapy product from a non-profit applicant.
FDA Press Release: FDA Approves First Gene Therapy Treatment for Wiskott Aldrich Syndrome

The disease was named for the work of Dr. Alfred Wiskott, a World War I veteran and physician, and Dr. Robert Aldrich, an American pediatrician who studied six generations of a Dutch family affected with the illness.
“The Week”: Has Science Finally Found a cure for Wiskott Aldrich Syndrome?

New Gene Therapy for Spinal Muscular Atrophy

The FDA approved Novartis’ gene therapy Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene. Novartis states that “Itvisma is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population.” Itvisma has a boxed warning about the risk of liver injury.

FDA Press Release FDA Approves Gene Therapy Treatment for Spinal Muscular Atrophy
Novartis press release: Novartis receives FDA approval for Itvisma
Muscular Dystrophy Association: “What is Spinal Muscular Atrophy?”

Two newsletters were sent today. In addition to this New Drug Approvals feature, a separate post (sent after this one) features Drug Safety Updates with warnings and recalls:
https://news.askapatient.com/p/new-warnings-for-ra-drug-actemra

Did you miss the last 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!

Today’s newsletter is a brief Thanksgiving edition, highlighting a recent drug pricing announcement from the Center for Medicare Services (CMS). We will return in two weeks with our regular edition containing drug safety news and more.

Newly negotiated, much lower prices for 15 drugs will go into effect in January 2027 for patients with Medicare insurance. CMS says the negotiated prices will save taxpayers roughly $12 billion a year compared with this year’s prices. For example, the cost to Medicare for Novartis’ Ozempic will drop from $959 a month per patient to $274 per month. In 2024, 2.3 million Medicare patients age 65 and up took Ozempic. Here are some more examples of monthly price reductions:

• Trelegy Elipta, for asthma and COPD: $654 to $175 (GSK)

• Breo Elipta, for asthma and COPD: $397 to $67 (GSK)

• Linzess, for chronic constipation: $539 to $136 (AbbVie)

• Xtandi, for prostate cancer: $13,480 to $7004 (Astellas)

These new prices are the list price Medicare will pay, representing an upper level cap for patients; patient out-of-pocket prices might be lower, depending on their specific “Part D” (Medicare medications) plan. For example, if a Medicare patient who has met his deductible is required to pay 25% of the drug cost as a co-pay, with current prices Ozempic would be 25% of $959 or $235. With the new pricing in 2027 and the same 25% co-pay, it would be just $68 a month. Some of the drugs will be new options for Medicare patients, since all Part D plans will be required to offer access to the drugs. Check here for the complete list of the 15 drugs, old and new prices, and number of Medicare patients taking each of the drugs:

CMS: Fact Sheet with Drugs and Prices for 2027

CMS Press Release (November 25, 2025) : “CMS Delivers Savings for Seniors on 15 Major Drugs for Cancer and Chronic Disease”

Lower Prices for 10 Drugs in January 2026

While you’ll have to wait another year for the lower prices on Ozempic, Linzess, and other drugs mentioned above, you only have to wait about a month for reduced prices on ten others, listed below. In August 2024, CMS announced the first ten drugs with newly negotiated lower prices. These new prices, listed below, will take effect in January 2026 and represent a monthly (30 day) price:

• Eliquis, for blood clots: price reduced from $521 to $231 (Bristol Meyers Squibb)

• Entresto, for heart failure $628.00 to $295.00 (Novartis)

• Enbrel, for rheumatoid arthritis: $7,106 to $2,355 (Immunex)

• Farxiga for Type 2 diabetes: $556.00 to $178 (AstraZeneca)

• Imbruvica, for blood cancer: $14,934 to $9319 (Pharmacycles)

• Januvia, for Type 2 diabetes: $527 to $113 (Merck)

• Jardiance, for diabetes: $573 to $197 (Boehringer Ingelheim)

• Novolog insulin pens (various) for Type 2 diabetes: $495 to $119 (Novartis)

• Stelara, for rheumatoid arthritis and ulcerative colitis: $13,836.00 to $4,695.00 (Jannsen)

• Xarelto for blood clots: $517 to $197 (Janssen)
  
  The new prices are the list price Medicare will pay, representing an upper level cap for patients; patient out-of-pocket prices might be lower, depending upon a person’s prescription (Part D) plan. All Medicare patients will have access to the drugs. In 2025, patients had an out-of-pocket cap of $2,000 for medications; this will rise to $2,100 in 2026. Like last year, Medicare patients in 2026 won’t have to worry about the “donut hole,” a situation where prior to 2025, some patients had to pay thousands of dollars out-of-pocket until they reached a “catastrophic limit” of over $6,000. Check this CMS fact sheet for total expenditures by brand name drug, number of patients taking, and more:

Fact sheet on 2026 Negotiated Lower Drug Prices (CMS)

Did you miss our last newsletter? Read it here:

After comparing Caplyta’s “old” (June 2023) drug label with the newly revised label (November 2025), it is notable that the Tardive Dyskinesia Warning Section was scaled back, even though movement-related side effects were more prevalent compared with placebo in the trials for the new indication. We won’t get into the clinical trial effectiveness results here (which were favorable), as we are only looking at the adverse events warning changes.

Background

Caplyta (lumateperone, 42mg) was first approved in 2019 as an “atypical antipsychotic” treatment for schizophrenia. It later received approval for bipolar disorder in adults and also as an add-on treatment for bipolar-related depression to be used either alone or along with lithium (a mood stabilizer) or valproate (an anticonvulsant). The drug was developed by Intracellular Therapies, but was purchased by Johnson & Johnson (J&J) in early 2025 for $14.6 billion.

New Indication for Caplyta: Major Depression

On November 5, 2025, Caplyta received expanded FDA approval as a treatment for major depressive disorder (MDD) in adults, to be used along with an antidepressant. Adults who don’t respond to an antidepressant alone (any type) may now be prescribed the antipsychotic as an adjunctive treatment. Fierce Pharma notes that this new indication will “super-size the market for Caplyta, as MDD affects about 22 million adults each year, according to J&J. . .which is anticipating Caplyta will eventually bring in $5 billion in annual sales.”

The clinical trial studies that supported its approval (Study 501 (NCT04985942 and Study 502 (NCT05061706) for major depressive disorder were six weeks long and compared Caplyta/Antidepressant with a Placebo/Antidepressant combination. The third study (called Study 503 with the code NCT0561719) was only open to patients who had actually completed one of the first two studies. That study was open label (all patients took Caplyta plus an antidepressant) and looked at long-term (six months) efficacy and safety. Data for that long-term trial is not yet included in the drug label.

Caplyta’s revised drug label, which includes a Patient Medication Guide, adds that the most common side effects reported in the MDD study were dizziness, drowsiness, and sedation. Importantly, the “Patient Medication Guide” warning about Tardive Dyskinesia was kept intact, and remained the same as the 2023 version.

Movement Disorder Risks

However, with no apparent connection to the new MDD indication or research, the main label content (section 5.5) on the risk of “Tardive Dyskinesia” (TD) was revised. Although second-generation antipsychotics like Caplyta generally have less movement-related side effects like tremors, muscle spasms, gait disturbances, and tardive dyskinesia than first-generation drugs, the risk still exists. Also, Caplyta is so new that long-term side effect risks are still unknown.

The “Tardive Dyskinesia” risk section is noticeably shorter (about half the length) compared with the previous version. It removes the definition of the condition (“Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs”), and moves the warning about the relationship between long-term use and the increased likelihood of it being an irreversible condition into a paragraph about increased risk of TD in elderly women. The new label also removes the paragraph cautioning that prescribing should happen in a manner that is “most likely to reduce the risk of tardive dyskinesia.” Together, these revisions seem to weaken the strength of the warnings about TD.

The revisions to the TD warning section are surprising, considering that the MDD clinical trial had a higher prevalence of extrapyramidal (movement-related) side effects for Caplyta + antidepressant vs. placebo + antidepressant than did the trials for other indications (bipolar-related depression and schizophrenia). For the MDD study, the clinical trial adverse events summary states:

“In the 6-week, adjunctive MDD trials, the frequency of reported EPS-related adverse reactions (tremor, bradykinesia, muscle spasms, gait disturbance, tongue spasm, muscle tightness and dyskinesia), excluding akathisia and restlessness, was 5% for CAPLYTA-treated patients and 0.8% for placebo-treated patients.”

Compare this with the EPS (movement related) types of adverse events occurring in the trials for the other approved indications:

• For the schizophrenia trials, the frequency of EPS-related reactions was 6.7% for the CAPLYTA-treated patients and 6.3% for placebo-treated patients.
  (Could it be that some of the schizophrenia patients participating in the Caplyta trial had already developed TD from previous years of medication, so that the difference in the prevalence of this adverse effect between the tested drug and placebo was not as great as in the MDD trial, which likely included patients who had never taken an antipsychotic before?)

• For the monotherapy bipolar depression trials, the frequency of reported EPS-related reactions was 1.3% for CAPLYTA-treated patients and 1.1% for placebo-treated patients.
  (These results suggest that the antidepressant-Calypta combo may be more likely to result in the EPS-related reactions than the antidepressant or Caplyta alone (see below).

• For the adjunctive bipolar depression trials (where lithium or valproate was also used) the frequency of reported EPS-related reactions was 4% for CAPLYTA-treated patients and 2.3% for placebo-treated patients.

  (Because the difference was less than 2%, that adverse reaction was not included in the clinical trial adverse event comparison table. Also, the result suggests that the antidepressant-Calypta combo may be more likely to result in the EPS-related reactions than the antidepressant or Caplyta alone.)

The below chart is from the most recent drug label, providing clinical trials adverse reactions for the MDD trials. Note the “Tremor” adverse reaction of four percent for patients taking Caplyta:

A Takeaway

While this drug has been “on a roll” and much celebrated in the media, safety concerns exist. The additional approval means that a huge new patient population, most likely without prior antipsychotic experience, will soon be taking this drug. Based on the MDD clinical trials results, it seems like a new “movement-related” warning should have been added to the Patient Medication Guide for the MDD indication.

Even if the longer terms trials show that the movement related disorders go away eventually or are not serious, it should be disclosed that the effect can happen early in treatment. Many patients don’t look at the clinical trial results and won’t know about this new risk unless their doctor has thoroughly read the drug label and shares the information with a patient considering taking the new medication.

In addition, while we don’t know whether the FDA questioned what appears to be a weakening of the warnings section on Tardive Dyskinesia, it would be helpful if the drug sponsor’s reasoning for all significant labeling changes were required to be included in the publicly accessible FDA letters to drug sponsors. For now at least, the television/video ads include the same warnings about TD that existed before the label update. However, the other types of movement disorders that occurred during the MDD trials are not mentioned in the commercials that promote the drug as an add-on for treating depression.

Sources and More Reading

Caplyta Drug Label Safety Update (November 2025) and links to current and previous drug labels.

Cleveland Clinic: “Antipsychotic Medications”

Psychiatric Times: Interview with Principal Investigator (Intra-Cellular Therapies) for Caplyta

Fierce Pharma “JJS Caplyta Supersizes Its Reach with Lucrative Expansion for Major Depressive Disorder”

FDA: “FDA Changes to an Approved Drug” and “Frequently Asked Questions about Labeling for Prescription Medications”

Clinical Trials are linked within this article.

Ratings for Caplyta: Patient Opinions About Caplyta (Please add yours!)

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”

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

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.

Glasses for Preventing Progression of Nearsightedness (Myopia) in Children

Since the 2010s, contact lenses designed to slow the development of nearsightedness (myopia) in children have been available in the U.S., but many kids have trouble inserting and wearing contact lenses. Now, there is an eye glasses option. The FDA authorized Essilor’s Stellest eyeglass lenses to correct and slow the progression of myopia, with or without astigmatism in children 6 to 12 years old at the start of treatment. Myopia affects approximately 40% of the U.S. population, with prevalence increasing rapidly among children and adolescents. The Essilor Stellest eyeglass lenses have a clear 9mm diameter area in the center, which is surrounded by rings of tiny, raised dots (peripheral “lenslets”). The tiny, raised dots provide peripheral light defocus, which may help to slow the progression of myopia in children. It is recommended that the child wears the lenses for a minimum of 10 hours per day for at least 6 days per week.

FDA Press Release: “FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia”

Keytruda Subcutaneous Formulation

The FDA approved Merck’s subcutaneous (under-the-skin) version of cancer drug Keytruda, offering an alternative to drug infusion but without meaningful differences in outcomes or safety. The new formulation also allows Merck to retain additional years of patent protection for Keytruda.

According to Bloomberg Law, “Merck is performing a sleight-of-hand known as a “product hop” by tweaking how the drug is delivered. Last year, Keytruda brought in about $29.5 billion globally for Merck. In February 2023, four members of Congress urged the US Patent and Trademark Office to scrutinize Merck’s Keytruda patent portfolio, saying its applications appeared to reflect “anti-competitive business practices,” such as “patent thicketing” and product hopping.

FDA Press Release: FDA Approves pembrolizumab-and-berahyaluronidase-alfa-pmph subcutaneous injection

Bloomberg Law: “Merck’s New Keytruda Shot is a Rare Real Time Product Hop”
Have you taken Keytruda? View ratings or add your experience.

New Treatment for Barth Syndrome

The FDA granted accelerated approval to Stealth Biotherapeutics’ Forzinity (elamipretide) subcutaneous injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg (66 pounds). As a condition of accelerated approval, FDA is requiring a post-approval randomized, double-blind, placebo-controlled trial to confirm that the changes seen on knee muscle strength translate into patient benefit. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells) that primarily affects boys. The disease begins with severe heart failure in infancy, and often causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance.
FDA Press Release: FDA Grants Approval for First Treatment for Barth Syndrome
Read more about Barth Syndrome at Medline Plus

Nine Drugs for Common Conditions Slated for New Fast Approval Program

In June, FDA Commissioner Martin Makary introduced a new drug approval pathway, called the National Priority Voucher (CNPV) pilot program. The CNPV pilot program aims to reduce drug and biological product application or efficacy supplement review times from about a year to just 1-2 months. This CNPV program is different than the “Orphan drug” or “Accelerated approval” pathway that speeds up drug approvals for rare diseases. Instead, it focuses on “accelerating cures and meaningful treatments with historic public health impact for Americans,” with a focus on common chronic conditions, high prevalence diseases, increased affordability, and on-shoring drug development and manufacturing so that there is less dependent on foreign facilities for production of essential medicines.

The first nine drugs selected to be reviewed under this program include:

1. Pergoveris for infertility

2. Teplizumab for Type I diabetes

3. Cytisinicline for nicotine vaping addiction

4. DB-OTO for deafness

5. Cenegermin-bkbj for blindness

6. RMC-6236 for pancreatic cancer

7. Bitopertin for porphyria

8. Ketamine for domestic manufacturing of a critical drug for general anesthesia

9. Augmentin XR for domestic manufacturing of a common antibiotic

FDA Press Release: “FDA Awards First-Ever National Priority Vouchers to Nine Sponsors “

Drug Research

Potential for RA Drug as New Diabetes Type 1 Treatment

Rheumatoid arthritis (RA) drug baricitinib (brand name Olumiant) has shown promise as a treatment for Type 1 diabetes. In 2023, an Australian trial reported that a daily pill of baricitinib could safely preserve the body’s own insulin production and slow the development of type 1 diabetes in those recently diagnosed. A follow-up trial presented at the Annual Meeting of the European Association for the Study of Diabetes, held in Vienna last month, revealed that once baricitinib treatment was stopped, participants’ diabetes progressed.
Newsweek: Daily Pill May Slow Progression of Type 1 Diabetes-‘Really Exciting Step’

Read or add patient reviews or view the adverse events case summary for Olumiant (baricitinib). Olumiant gained additional approval recently as treatment for severe alopecia (autoimmune-related) and for hospitalized patients with Covid-19 requiring supplemental oxygen.

Aspirin and Preventing Colon Cancer Study

A Swedish research study published last month in the New England Journal of Medicine concluded that aspirin can dramatically reduce the likelihood of colorectal cancer recurrence in patients with a certain gene mutation. Patients who had their tumors removed received either 160 mg of aspirin (half a standard tablet) or placebo per day and were followed for three years. These cancer patients had a common gene mutation called PIK3CA. There was a 7.7 percent recurrence rate in the aspirin takers compared to a 14 percent return in the patients on placebo, a relative risk reduction of 50 percent. The People’s Pharmacy’s Joe Graedon notes that a study also published in the New England Journal of Medicine 34 years ago concluded favorable results for colon cancer patients taking aspirin.
People’s Pharmacy: “Aspirin Vs. Cancer: What are We Waiting For?”

Pain Treatment Research

A Cleveland Clinic study found that a series of low-dose ketamine infusions can help reduce chronic pain and improve quality of life for many patients. Nearly half of those who had infusions reported significant improvements that lasted for months. The study was published in Regional Anesthesia & Pain Medicine.
Cleveland Clinic: “Cleveland Clinic Study Demonstrates Safety, Effectiveness of Ketamine for Chronic Pain”

Pharmacies in Jeopardy Over PBM Practices

The National Community Pharmacists Association reports that Rite Aid, once the third-largest pharmacy chain in the United States, has closed all of its stores and filed a lawsuit against CVS Caremark (one of the “big three” Pharmacy Benefit Managers), alleging that it charged Rite Aid $500 million in clawbacks for prescriptions that were already filled and paid for. It said those penalties violated their contract and lined the PBM’s pockets. Ultimately, they say CVS drove them out of business and to boot, CVS has now acquired about 717 stores’ worth of Rite Aid’s customers’ prescriptions.

The Federal Trade Commission (FTC) is investigating the big three PBMs for their business practices and allegations of anti-competitive behavior. Three major PBMs control more than 80 percent of all prescriptions filled in the U.S.: CVS Caremark, OptumRx and Express Scripts.
NCPA Press Release: “Rite Aid Sues CVS Caremark for Anticompetitive Behavior”

Gabapentin Prescriptions Soar

The number of gabapentin prescriptions dispensed last year increased to over 70 million; it is the fifth most prescribed drug in the U.S. (only behind atorvastatin, amlodipine, levothyroxine, and lisinopril). Our updated article explains some of the contributing factors to this trend and emerging safety concerns.
AskaPatient: “What is Gabapentin Used for and Why are So Many Patients Taking It?”

2025-2026 Influenza Season Update

Just like last flu season, each of the nine influenza vaccines offered this year are trivalent (cover three strains of flu virus) instead of the usual quadrivalent vaccines. The “Yamagata” flu strain, which had its heyday in the 1990s, has not been detected in the population since March 2020, thanks to the dramatic drop in flu infections during the Covid-19 pandemic. That strain was dropped from the vaccine last year.

However, even with less strains around, last year was a very bad flu season; in fact, the CDC says that the 2024-2025 influenza season was the first high-severity influenza season for all age groups since the 2017-2018 season. This season, the CDC predicts we will have “moderate” levels of influenza. Check out the list of vaccines (including a self-administered one and egg-free varieties) and more information about the upcoming flu season.
Ask a Patient: “2025-2026 Flu Season: Influenza Vaccine Supply”

Supplement Tips: Results of Three Labs Testing for Lead in Protein Powders

Are you getting enough protein? The recommended daily protein requirement is about 0.40 gram per pound of body weight for sedentary individuals, 0.55 to 0.65 gram per pound for endurance athletes and 0.65 to 0.80 gram per pound for strength athletes. Consumer Reports notes that for a 170-pound adult, that’s a daily intake of about 61 grams of protein, which can be achieved by eating a cup of plain Greek yogurt and 3.5 ounces of chicken breast.

So while most people should be able to get enough protein from their diet, there are research-backed medical reasons people might need more protein: to retain muscle mass during periods of bed rest, maintain muscle during chemotherapy, help with recovery after hospitalization, help control blood sugar levels, and to increase the protein level in the blood of kidney failure patients undergoing dialysis.

While protein powders and drinks can be healthy, testing has shown that high levels of lead and other heavy metals are present in some products. Consumer Reports, Consumer Labs, and the Clean Label Project recently conducted heavy metal tests (lead, mercury, cadmium, arsenic) on various protein powders, and all three found that plant-based products had far more lead than whey (dairy-based) protein powders and shakes.

Of the 23 protein powders and ready-to-drink shakes tested by Consumer Reports, a single serving contained as much as ten times more lead than CR’s food safety experts say is safe to consume in a day. One of Consumer Reports’ recommended products was Optimum Nutrition Gold Standard 100% Whey Chocolate, which was also a Consumer Labs’ Top Pick for flavored whey protein (Double Rich Chocolate version).

Consumer Labs also found that overall, the non-flavored products had less contaminants than flavored ones, and that on average, organic protein powders contained three times more lead and twice the amount of cadmium as non-organic products.

The news isn’t all bad; the Clean Label Project, which recently tested 160 top-selling protein powders, found that only 3 of the powders contained detectable bisphenols (including BPA and BPS).

Find the complete reports, with product recommendations based on test results:

Consumer Reports: “Protein Powders and Shakes Contain High Levels of Lead”
(free article)

Consumer Lab: “Protein Powders, Shakes, Drinks, Nutrition Drinks”
(subscription required)

Clean Label Project Protein Powder Testing Results: Clean Label Project Protein Study 2.0
(free report; also includes a link to their downloadable “Clean 16 protein powder products”

Thank you for reading! Next time, we’ll feature drug safety news, including product recalls, new risk statements added to drug labels, and more.

Did you miss the last edition of this newsletter? If so, you may read it here:

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

Sunday’s newsletter will be delayed by a day; look for the next edition on Monday, October 6.

Thank you for your support! In the meantime, check out updated and expanded adverse event summaries on our website, with the 20 most commonly reported adverse reactions reported to the FDA for thousands of medications! Browse a list of available reports using the alpha-list or find a specific drug by using the form at the top of each page of the Ask a Patient website. For example, here is a link to the Ozempic report:

Adverse Events Summary for OZEMPIC: 40,933 Reports Received by FDA (FAERS-Medwatch) - AskaPatient.com

Charts and graphs with adverse reactions, outcomes, patient ages and sex, number of reports by year, and more for OZEMPIC (SEMAGLUTIDE) as reported in 40,933 cases to the FDA through June 2025 in the FAERS and MedWatch database.

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

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.

The World Health Organization’s 24^th edition of its “Model List of Essential Medicines” (EML) and 10^th edition of the “Model List of Essential Medicines for Children” (EMLc) were released September 5 and include 523 medicines for adults and 374 pediatric medications. Updated every two years and used by more than 150 countries, the EML serves as a catalog of the drugs that WHO believes should be available to meet a country’s priority health care needs. Inclusion of a drug on the list helps to ensure access to vital medications for people in poorer countries.

The WHO Essential Medications Expert Committee met in Geneva in May 2025 and after considering 59 applications, selected 20 new drugs for inclusion in the EML and 15 new drugs for the EMLc. Notable additions:

• Semaglutide, a GLP-1 drug, was added to treat patients with Type 2 diabetes with established cardiovascular disease (CVD) or chronic kidney disease (CKD); and with obesity (body mass Index (BMI) ≥ 30kg/m2). Semaglutide is the active ingredient in Ozempic and Wegovy. The Committee recommended that WHO work on existing approaches for managing prices and evaluate alternative strategies to improve affordability and access to reduce the global burden of diabetes. Semaglutide is expected to go off-patent in 2026 in the U.S. (although it varies by country), so more affordable biosimilar (generics) may be available soon.

• Pembrolizumab (Keytruda brand name) was added to the EML as a first-line therapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer. For metastatic non-small cell lung cancer (NSCLC), atezolizumab and cemiplimab were included as therapeutic alternatives.

• The combination of elexacaftor + tezacaftor + ivacaftor (Trikafta brand name) was added as a treatment for cystic fibrosis, along with ivacaftor (Kalydeco brand name) as a stand-alone treatment.

• Cytisine was added as a nicotine addiction (stop-smoking) treatment. Cytisine is not approved yet in the U.S., but has an application under consideration.

The following drugs were rejected from inclusion in this edition:

• Semaglutide was NOT included as a stand-alone treatment for obesity. (However it was included for Type 2 diabetes with obesity as noted above.)

• The stimulant methylphenidate (brand name Ritalin) was NOT included as a treatment for ADHD for adults or children. The committee had concerns about long-term safety of the medication. They also noted that the drug is already included on some countries' list of essential medications. Attention deficit hyperactivity disorder (ADHD) is not a medical condition included in the EML or the EMLc.

• Brexpiprazole (Rexulti brand name) was NOT included as an add-on treatment for major depressive disorder in adults based on evidence from short-term studies showing only modest incremental benefits compared to placebo, with the committee noting other atypical antipsychotics and lithium had similar or superior gains.

• The EMLc continues to exclude drugs treating mental and behavioral disorders in children.
  Beginning in 2023, the WHO removed the entire section 24, which covers Mental and Behavioral Disorders, from the Children’s Essential Medications List (EMLc). No mental and behavioral disorder medications are recommended by WHO for patients under the age of 13.

Press Release: "WHO updates list of essential medicines to include key cancer, diabetes treatment"
WHO Model List of Essential Medicines, 24th Edition (2025) Executive Summary
WHO 10th List of Essential Medicines for Children (2025)

The Mental and Behavioral Disorders section of the EML includes medications deemed essential for treating depression, bipolar disorders, anxiety disorders, obsessive compulsive disorders, psychotic disorders, and substance abuse in adults only. Check out our summary of the included drugs.

Commercial Medical Sterilization Facilities Granted Extra Time to Comply with New EPA Standard

Susan Kamuda developed breast cancer after decades of exposure to ethylene oxide (EtO) emissions from Sterigenics’ commercial medical device sterilization plant near her home in Willowbrook, Illinois. Her 2022 lawsuit (in which she was awarded over $300 million by a Cook County jury), followed by hundreds of other such lawsuits, brought nationwide attention to the cancer risks of EtO facility emissions.

Ethylene oxide (EtO) gas is essential for sterilizing many heat- and moisture-sensitive medical devices, such as catheters, stents, wound dressings, and implants. These are items that often have hard-to-reach components and cannot be sterilized using other available methods like autoclave steam pressure chambers. The FDA says that ethylene oxide is used to sterilize 20 billion devices sold in the U.S. every year, accounting for about 50 percent of devices that require sterilization. In August 2022, the FDA announced efforts to find alternatives to ethylene oxide sterilization methods and since then has held multiple town halls on the topic. In January 2024, they announced a plan to broaden the use of vaporized hydrogen peroxide (VH2O2), an established method of sterilization for medical devices.

New EPA regulations require commercial sterilization facilities to drastically reduce EtO emissions. Deadlines were set for 2025 for reducing emissions or finding alternative ways to sterilize the equipment, but there have been technological and financial hurdles, leading to delayed compliance.

The White House recently granted some sterilization plants regulatory relief, giving them more time or flexibility to meet standards while maintaining critical sterilization capacity. Many communities surrounding the facilities are not happy that the facilities will be allowed to continue to operate without fixing the emissions. Check here for a list of the facilities:
White House: List of Medical Sterilization Facilities Granted Regulatory Relief

33 states have at least one commercial EtO commercial sterilization facility. The facility names and addresses in the link below are listed by state and city.
Environmental Protection Agency: EPA List of Commercial Sterilization Facilities
Hazardous Air Pollutants: Ethylene Oxide

New Drug Approvals

Vizz (aceclidine) Eye Drops for Presbyopia

LENZ Therapeutics’ Vizz (aceclidine) was approved for the treatment of age-related fuzzy near vision (presbyopia) in adults. In its press release, LENZ states that acedeline contracts the sphincter of the iris, “resulting in a pinhole effect that extends depth of focus to improve near vision without causing a myopic shift.” This allows for clear distance vision, and the effects are said to last for about 10 hours. If needed, contact lenses for distance vision may be used after inserting the Vizz eye drops. While aceclidine has never been approved for use in the U.S. until now, Ophthalmology Times reports that it in Europe it is a glaucoma treatment.

Allergan’s Vuity, approved in 2022 and Orasis’ Qlosi, approved in 2024, also correct presbyopia by constricting the pupils, but they contain the active ingredient pilocarpine and require additional doses for the longer-term (9 hours) effect. All three of these products warn users to be cautious driving at night or when doing hazardous activities in areas with dim light. Ophthalmology Times reports that two additional drugs for correcting presbyopia are in the FDA pipeline.

LENZ Therapeutics Press Release
Ophthalmology Times: “The emerging era of presbyopia-correcting eye drops: What’s next?”

Wegovy (semaglutide) Subcutaneous Injection for Liver Disease

Novo Nordisk’s Wegovy (semaglutide) received FDA approval for treating adults with the liver disease noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), with moderate to advanced liver scarring. MASH is a severe form of metabolic-associated fatty liver disease that develops when fat buildup in the liver causes inflammation and scarring. The FDA states that approximately 6% of U.S. adults (14.9 million people) have MASH. Wegovy was originally approved in 2017 for weight loss in patients with obesity.
FDA Press Release

Tonmya (cyclobenzaprine hydrochloride) Sublingual Tablets for Fibromyalgia

Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine hydrochloride sublingual tablet) was approved for the treatment of fibromyalgia in adults. Until now, the FDA has approved only three medications for fibromyalgia: duloxetine (Cymbalta), pregabalin (Lyrica), and milnacipran (Savella). Pain News Network cautions that this is not a breakthrough treatment: Tonmya acts more like a sleeping pill than a pain drug. Cyclobenzaprine hydrochloride has been available since 1977 to treat muscle spasms. The FDA is requiring that Tonix conduct additional clinical trials to assess adverse maternal, fetal, or infant outcomes.

Fibromyalgia is a chronic condition that causes pain all over the body, fatigue, and other symptoms. Read more about fibromyalgia at Medline Plus.
Pain News Network: “FDA Approves First New Fibromyalgia Drug in 15 Years”
FDA Approval Letter

Brinsupri (brensocatib) Tablets for Bronchiectasis

Insmed's Brinsupri (brensocatib) was approved for patients age 12 and up to treat non-cystic fibrosis bronchiectasis, a chronic condition that damages the lungs and makes it hard to clear mucus. According to Insmed, there are about 500,000 people in the U.S. diagnosed with NCFB, with millions more estimated to be living with the disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. Brinsupri tablets are taken once daily.
Insmed Press Release

Beetroot juice for lowering blood pressure

The People’s Pharmacy’s Joe Graedon revisits the topic of beet juice as a good dietary choice for lowering blood pressure, explaining new research that supports its use. According to the study, here’s how it worked: the beet juice led to healthy changes in the oral microbiome, which helped metabolize the nitrates in beet juice into nitric oxide, leading to more relaxed blood vessels.
People’s Pharmacy: “Beet Juice was Better than Drugs for Lowering Blood Pressure”

Did you miss these recent posts?

Companies marketing naturally-derived thyroid hormone for hypothyroidism received warnings from the FDA. The biological medications aren’t FDA-approved, but are helpful for some patients for whom synthetic versions like levothyroxine just don’t work.

Next edition will include Drug Safety Updates for September. Thank you for reading! Visit our website at www.askapatient.com for more on drug treatments.