FDA to require new warning on GLP-1s due to vision loss

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The FDA warned about a potential eye condition, NAION, linked to GLP-1 drugs. It requires manufacturers like Novo Nordisk (Wegovy, Ozempic) and Eli Lilly (Zepbound, Mounjaro) to update packaging warnings. Lawsuits allege insufficient warnings, while evidence of a link remains mixed. Both companies prioritize patient safety and monitor the issue.

The FDA added a vision loss warning to all GLP-1 drugs, including Ozempic, Wegovy, Mounjaro, and Zepbound. The warning follows a study linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION). The FDA's analysis found NAION in 6 out of 100,000 patients using GLP-1 drugs for a year, compared to less than 4 per 100,000 for other treatments. Manufacturers Eli Lilly and Novo Nordisk acknowledged the update but emphasized patient safety and the benefits of their drugs.

The FDA now requires GLP-1 drugs, including Ozempic, Wegovy, Mounjaro, and Zepbound, to carry a warning about a rare eye condition (NAION) that may cause sudden vision loss. The condition is rare, affecting 2.3 to 10.2 per 100,000 adults over 50 annually. Novo Nordisk and Eli Lilly note the data do not establish a direct cause-and-effect link. The FDA reviewed clinical trials and other data after a 2024 study linked semaglutide to the condition.

The FDA is mandating new warning labels for GLP-1 drugs, including Mounjaro, Zepbound, and Trulicity, due to a rare risk of vision loss from 'eye stroke.' According to the FDA, the risk is significant enough to warrant a warning, though the complication rate is low. Eli Lilly and Novo Nordisk, makers of these drugs, have responded to the update.