Nationwide eye drops recall; New lung, liver, ovarian cancer drugs; Gene therapy trial tragedy; new migraine injectable; Allergy med tips; Fish oil supplement good news; more
1.8 Million Cartons of Eye Drops Recalled
A nationwide eye drops and artificial tears products recall is underway for more than 75,000 cases (1.8 million cartons) of eye drops distributed by AvKARE (Pulaski, Tennessee), due to manufacturing problems and lack of assurance of sterility. The recall was initiated by BRS Analytical Services, an independent contract testing laboratory based in St. Louis, Missouri.
AvKARE’s notice states that the recall is at the retail level; this type of recall normally does not affect consumers because either the retailers remove the products from shelves before consumers buy them OR the recall reason might not be serious enough for a consumer level recall. However, since the products were distributed and shipped between May 26, 2023, and April 21, 2025, many consumers might have affected products. They should check the lot numbers and NDC numbers listed at the AvKare website or on the FDA recall enforcement report.
https://www.nbcchicago.com/news/health/eye-care-product-recall-a-list-of-products-included-in-nationwide-alert/3744415
New Drug Approvals
Avmapki (avutometinib) capsules and Fakzynja (defactinib) tablets for ovarian cancer
The FDA granted “accelerated” approval for Verastem’s combination treatment of Avmapki capsules and Fakzynja tablets Co-pack for adults with a specific genetic mutation (“KRAS”) and low-grade serous ovarian cancer (LGSOC). The accelerated approval means that continued approval is contingent on the final results of an ongoing clinical trial.
Patients are warned that eye problems are common and can be severe; they will see an eye care professional before and during treatment. In clinical trials, 68% of the 57 trial participants experienced eye-related adverse reactions. Liver toxicity and muscle problems also are common. This drug is a “kinase inhibitor,” which works by targeting enzymes (kinases) that are involved in cell signaling and growth.
FDA Press Release
Emrelis (telisotuzumab vedotin-tllv) IV injection for lung cancer
The FDA granted AbbVie’s Emrelis injection accelerated approval to treat certain types of advanced, non-squamous non-small cell lung cancer (NSCLC). Emrelis is an “antibody drug conjugate,” acting as "guided-missiles that target only cancer cells while sparing healthy cells.” In the clinical trial, about 35% of the 84 participants responded positively to the drug. A late-stage clinical trial is still ongoing. The FDA also approved a companion lab test that helps determine if the patient has the kind of cancer that might be receptive to the drug.
FDA Press Release
Reuters Press Release on Emrelis
Opdivo (nivolumab) and Yervoy (ipilimumab) IV injections for advanced liver cancer
The FDA approved Bristol Meyers Squibb’s cancer drugs Opdivo and Yervoy to be taken together as a first-line treatment for treating advanced liver cancer (unresectable or metastatic hepatocellular carcinoma, HCC). The approval was expedited using the FDA’s “Oncology Center of Excellence Real-Time Oncology Review (RTOR)” process. Opdivo and Yervoy are currently approved individually for treating many kinds of cancer.
FDA Press Release
Brekiya (ergotamine derivative) autoinjector for migraines and cluster headaches
The FDA approved Amneal’s Brekiya, a new formulation of ergotamine that will be marketed as an easy-to-use and easy-to-carry device for treating (not preventing) migraine and cluster headache attacks. The prefilled autoinjector device is contains one dose and is administered subcutaneously.
Pharmacy Times announcement
Brekiya product label at FDA
The only other self-injectable medication approved for migraines is Emgality. However, Emgality is administered once a month and is used to prevent migraines while Brekiya is used as-needed at the onset of a migraine or cluster headache attack.
Cervical cancer test for at-home use
The FDA approved the first at-home test to detect the presence of 14 types of high risk HPV, the virus that causes cervical cancer. It is available by prescription from Teal Health and is mailed directly to the patient. A self-collected sample of vaginal cells using the “Teal Wand” is shipped to a lab for processing.
Many insurance companies are expected to cover the cost; Teal Health is working on expanding coverage. Shipping will begin in California before expanding to other states. The company website states that Teal’s “primary HPV test” is more sensitive than a Pap smear alone, which only can detect cervical cell changes once they have happened.
https://www.usatoday.com/story/life/health-wellness/2025/05/09/fda-at-home-cervical-cancer-screening-test/83540646007/
Teal Health Website: “Primary HPV Test”
Tryptyr (acoltremon) eye drops
The FDA approved Alcon’s Tryptyr prescription eye drops for treating dry eye disease. This product is the first “TRPM8 receptor agonist” of the dry eye prescription remedies. It works by “stimulating corneal sensory nerves to increase natural tear production.” The drops are packaged in single-use vials, which treat both eyes. Dosing is one drop in each eye twice a day.
Gene Therapy Clinical Trial Halted after Patient Dies
Rocket Pharmaceuticals’ clinical trial for an experimental gene therapy has been discontinued after the death of a trial participant. The mid-stage trial was testing RP-A501 for the treatment of Danon disease, a rare genetic disorder, more common in males, that causes heart muscle damage and progressive muscle weakness.
The patient had received the one-time treatment in early May. About a week after the infusion he developed capillary leak syndrome, a condition in which blood vessels leak fluids and proteins, causing swelling and low blood pressure. He died soon after from “acute systemic infection.” The trial had enrolled 12 male patients age 8 and over with the condition. The age of the patient that died was not disclosed.
Investigators suspect that a new immune suppression agent (called a “C3 inhibitor”) recently added to the treatment regimen to enhance patient safety could have caused the reaction. The C3 inhibitor was given to the patient before and after the treatment. The only other patient to receive the immune suppression agent (but a smaller amount) also developed capillary leak syndrome. Rocket CEO Gaurav Shah said the company is "carefully evaluating whether a mechanism related to the new agent may have influenced immune responses in an unexpected or paradoxical way".
The FDA has officially paused Rocket Pharmaceutical’s gene therapy trial.
Rocket Pharmaceuticals Press Release
Genetic Engineering News: Danon disease patient dies
NIH estimates that between 15,000 to 30,000 patients in the U.S. and Europe have Danon disease. The only available treatment option is heart transplantation, which is associated with substantial complications and is not considered curative. Read more about Danon disease at National Institute of Health:
https://rarediseases.info.nih.gov/diseases/9730/danon-disease
Experimental gene therapy trials are risky: In March 2025, Sarepta Therapeutics reported a teen's death after receiving Elevidys, a gene therapy for Duchenne’s muscular dystrophy. In November 2024: one person died in Neurogene’s Phase I/II Rett syndrome study and another death occurred in the trial for Beam Therapeutics’ base editor BEAM-101 for sickle cell disease.
In June 2024, Elevidys received a controversial expanded approval:
https://news.askapatient.com/i/146144626/new-pediatric-drug-approval-duchennes-muscular-dystrophy
Medication and Supplement Tips
Beware of Itching after Discontinuing These Allergy Drugs
After many years of receiving complaints about severe itching withdrawal effects from allergy drugs cetirizine (Zyrtec) and levocetirizine (Xyzal), the FDA is finally requiring a warning on prescription and over-the-counter versions of the drugs. The FDA states that in 2022, an estimated 26.8 million cetirizine and levocetirizine prescriptions were dispensed from U.S. and 62.7 million packages of OTC cetirizine and levocetirizine products were purchased by consumers from U.S retail outlets.
FDA Statement on Stopping Allergy Meds after Long-Term Use
The People’s Pharmacy’s Joe Graedon has been urging the FDA to warn consumers about this side effect for years.
Weaning off Zyrtec and Xyzal can be difficult:
Check out these Ask a Patient reports of itching withdrawal symptoms
More about allergy meds: Can you take more than one type at the same time?
Susan Besser MD (Mercer Medical Center) explains that in most cases the OTC allergy medications should not be combined unless under the direction of a health care provider. However, there are certain exceptions when combining treatments is okay and even recommended, according to internists and allergists experts at “The Checkup.”
The Checkup: "Mixing Allergy Medicine"
Heart Benefits of Fish Oil Supplements
A recent re-analysis of previously published study data on the heart benefits of fish oil supplements found that people taking fish oil supplements were less likely to develop coronary heart disease or experience a heart attack. Originally, the study had found “non-significant” results. The new study was published in the American Journal of Clinical Nutrition (May, 2025).
The People’s Pharmacy’s Joe Graedon explains: “Omega 3 fats have been controversial for decades. Is fish oil good or bad for the heart? The most recent analysis of VITAL data says good!”
Flip Flops on Fish Oil: Omega 3 Fats DO Have Heart Benefits!
Some omega-3 fatty acid drugs are prescription-strength to lower triglycerides:
Vascepa Patient Reviews and Lovaza Patient Reviews at Ask a Patient website
Check out Consumer Lab’s overview article on fish oil supplements:
Fish Oil, Krill Oil, and Algal Oil Omega-3 (DHA & EPA) Supplements Review
(Article is free; specific product recommendation section requires subscription.)
Did you miss our last newsletter? Check it out here:
Our next issue will feature the June 2025 Drug Safety Updates.
Visit us at AskaPatient.com for consumer-contributed medication and vaccine ratings and reviews, along with additional drug and health-related information resources.