FDA Requires Stronger Warnings on GLP-1 Drugs Over Rare Risk of Vision Loss
by Milberg
The U.S. Food and Drug Administration has ordered safety labeling changes for all glucagon-like peptide-1 receptor agonists (GLP-1 RAs), a drug class that includes Ozempic, Wegovy, Mounjaro, Zepbound, and Trulicity. In a Drug Safety Communication issued November 9, the FDA said these medications carry a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden, painless vision loss in one eye, sometimes permanently.
Manufacturers must now add information about the risk to the Warnings and Precautions section of every GLP-1 RA label. The FDA’s review included a meta-analysis of 126 clinical trials, which found 6.4 NAION cases per 100,000 person-years among GLP-1 RA users compared with 3.8 among comparison patients. The agency also reported that NAION cases have been seen with every GLP-1 RA currently on the market.
The FDA advises patients to contact their health care provider right away if they notice sudden vision loss in one eye, blind spots or tunnel vision, color distortion, or blurry or hazy areas in central vision. Patients who have had NAION should talk with their doctor about whether to continue the medication.
“Losing vision can be catastrophic, and too many patients learn about this risk only after it happens. Over more than two decades of handling pharmaceutical cases, I’ve seen how much it matters when warnings reach patients and their doctors early. The FDA is now requiring that information on every GLP-1 label, and we’re committed to helping people who have been harmed understand their options.” – Vicki Maniatis, Senior Partner and one of our Dangerous Drug practice area leaders.
Milberg is investigating claims on behalf of individuals who have experienced vision loss after using GLP-1 medications. Anyone who believes they may have been affected can contact the firm for a free case review.
