The FDA is requiring the makers of every GLP-1 drug on the U.S. market, Ozempic, Wegovy, Mounjaro and Zepbound among them, to warn of a potential increased risk of an "eye stroke" that can cause sudden, permanent vision loss in one eye. The condition is non-arteritic anterior ischemic optic neuropathy, or NAION.
The agency's Nov. 9 drug safety communication puts the language in the Warnings and Precautions section of labels for a dozen products, from Byetta, approved in 2005, to Lilly's newly approved Foundayo. FDA said it "concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs" and told clinicians to consider discontinuing the drug in patients who develop NAION, unless the benefits clearly outweigh the risk.
FDA's review of 126 randomized trials covering 134,253 patients found 15 probable NAION events: 10 among patients on GLP-1 drugs, 5 on placebo and none on other glucose-lowering drugs. That works out to 6.4 cases per 100,000 person-years on GLP-1 drugs against 3.8 for comparators. The agency puts the background rate for adults over 50 at 2.3 to 10.2 cases per 100,000 people a year.
A separate FDA Sentinel cohort of type 2 diabetes patients from 2019 to 2024 s
