FDA Requires GLP-1 Warnings on Potential Blindness Risk

The FDA is requiring labels for GLP-1 medicines, including Ozempic, Wegovy, Mounjaro and Zepbound, to warn of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause sudden, painless and sometimes permanent vision loss in one eye. A review of 126 clinical trials found about 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 among people receiving placebo or other treatments; the evidence suggests a possible association but does not prove the medicines cause NAION, and the absolute risk remains low. The FDA advises patients not to stop treatment on their own and to contact a health professional promptly for sudden vision loss or other new vision problems; clinicians should consider ophthalmology evaluation if NAION is suspected and stopping treatment unless its benefits outweigh the risk. Manufacturers say they will continue monitoring safety and remain confident in the medicines’ overall benefit-risk profile. The warning comes amid wider scrutiny of GLP-1 safety, including lawsuits alleging gastrointestinal injuries that manufacturers dispute.