Drugs

FDA Orders Eye Safety Warnings for All GLP-1 Drugs

FDA is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs to add warnings about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden, permanent vision loss. NAION typically causes acute, painless vision loss in one eye and can result in permanent visual impairment.

The 11/9 Drug Safety Communication applies to the entire drug class, including Novo Nordisk's Ozempic and Wegovy, Eli Lilly's Mounjaro and Zepbound, and other GLP-1 therapies used for diabetes and obesity. FDA is requiring the risk information to be added to prescribing information’s Warnings and Precautions sections.

The action follows an FDA review of clinical trials, postmarketing adverse event reports, observational studies and animal data prompted by a 7/2024 study reporting an association between semaglutide and NAION.

FDA subsequently conducted a meta-analysis of 126 clinical trials involving 134,253 patients, including 78,217 treated with GLP-1 drugs and 56,036 receiving comparators. Investigators identified 15 probable NAION events: 10 among GLP-1 recipients and five among placebo recipients.

The incidence was 6.4 events per 100,000 patient-years among GLP-1 users compared with 3.8 events per 100,000 patient-years among comparator-treated patients.

Additionally, FDA said methodologically rigorous observational studies generally supported an association between GLP-1 treatment and increased NAION risk, although the agency's animal-data review did not identify a biological mechanism explaining the potential relationship.

The agency also acknowledged difficulties interpreting spontaneous adverse event reports because diabetes and other conditions common among GLP-1 users are themselves risk factors for NAION.

FDA Posts 18 Form 483 Inspection Records

FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative

FDA Probes Malignancy Risk Linked to Zolgensma Gene Therapy

FDA is investigating the safety of Novartis’ Zolgensma, an adeno-associated virus (AAV) vector-based gene therapy for spinal muscular atrophy (SMA), based on postmarketing adverse event reports of malignancies in treated patients. The adverse events include confirmed reports of “product-related insertional oncogenesis involving the GLI1 (Glioma-Associated Oncogene

Bias in Extension Studies Despite Their Value to FDA Safety Reviews: JAMA

Long-term clinical trial extension studies can provide important evidence about drug safety and durability of treatment effects, but their findings may be compromised by selection bias, patient attrition and the loss of randomized comparison groups, according to a 10/7 JAMA editorial. The editorial highlights a challenge for FDA

Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval

Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product. Means resigned 10/

Read more

FDA Posts 18 Form 483 Inspection Records

FDA Probes Malignancy Risk Linked to Zolgensma Gene Therapy

Bias in Extension Studies Despite Their Value to FDA Safety Reviews: JAMA

Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval