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FDA Orders Blindness Warning on Ozempic and ZepboundHealth
The FDA is requiring every GLP-1 drug, including Ozempic and Zepbound, to warn about a rare eye condition that can cause permanent vision loss.
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The United States Food and Drug Administration has ordered makers of every GLP-1 weight-loss and diabetes drug, including Ozempic and Zepbound, to add a warning about a rare eye condition that can cause permanent vision loss.
Announcing the change on Monday, 9 November, the FDA said it was requiring all medicines with GLP-1 receptor agonist activity to carry information about the potential increased risk of non-arteritic anterior ischemic optic neuropathy, known as NAION, in the warnings and precautions section of their labelling.
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NAION occurs when blood flow to the front of the optic nerve drops. The FDA describes it as a rare condition that can cause sudden, painless loss of vision in one eye, including permanent vision loss. Its underlying cause is not completely understood, and risk factors may include smoking, diabetes, high blood pressure, sleep apnoea, anaemia and kidney disease.
What the FDA’s review found
The warning covers about a dozen products, including Ozempic, Wegovy and Rybelsus, which contain semaglutide; Mounjaro and Zepbound, which contain tirzepatide; Victoza and Saxenda, which contain liraglutide; Trulicity, the combination products Xultophy and Soliqua, and Foundayo, which was approved in 2026. The FDA said NAION cases have been reported with every GLP-1 product currently on the market.
The review began after a study published in July 2024 raised the possible link between semaglutide and NAION. The FDA pooled 126 randomised trials involving 134,253 participants and found 15 probable NAION cases: 10 among patients taking GLP-1 drugs and five among patients given a placebo. That worked out at 6.4 cases per 100,000 person-years among GLP-1 users, against 3.8 in the comparison groups.
The agency stressed that it has not determined whether GLP-1 drugs can cause NAION, only that the evidence points to a possible increased risk that patients and doctors should know about. Europe’s medicines regulator reached a similar conclusion in June 2025, finding that NAION may affect up to 1 in 10,000 people taking semaglutide.
Drugmakers responded cautiously. Novo Nordisk said the available research does not establish a cause-and-effect relationship and that it remains confident in the benefit-risk profile of its medicines. Eli Lilly said it was carefully evaluating the update and would respond to the FDA promptly.
The FDA is not recalling the drugs or telling patients to stop taking them. But it says anyone using a GLP-1 medicine who notices sudden, painless vision loss in one eye, blind spots or tunnel vision, distorted colours or reduced central sharpness should contact a doctor right away and may need to be seen by an eye specialist.
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