The US Food and Drug Administration (FDA) has ordered manufacturers of GLP-1 drugs, including Ozempic, Wegovy, Mounjaro and Zepbound, to add a warning to their labels about a rare eye condition that can cause sudden and permanent vision loss.
In a drug safety communication issued on Monday, November 9, 2026, the agency said GLP-1 receptor agonist medications carry a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION). The requirement covers the whole drug class, including Soliqua, according to The National.
NAION occurs when blood flow to the optic nerve is reduced or stops. It can cause sudden, painless loss of vision in one eye. The FDA said patients with a history of NAION are at higher risk.
What the FDA reviewed
The agency said it based its decision on clinical trial data, animal studies, observational studies, case reports and post-market safety reports. According to Gizmodo’s account of the FDA’s review of 126 clinical trials, NAION occurred at a rate of 6.4 cases per 100,000 people a year among GLP-1 users, compared with 3.8 per 100,000 among non-users.
The FDA said cases have been reported for all GLP-1 drugs currently on the market, according to NBC News. Its scientists could not identify a mechanism explaining how the drugs might raise the risk, NBC News reported.
NAION risk factors, including type 2 diabetes, obesity, sleep apnoea and high blood pressure, overlap with conditions common among people who take GLP-1 drugs.
Advice for patients
The FDA said patients who have previously had a NAION event should discuss with their healthcare provider whether to continue taking their GLP-1 medication. Patients who notice sudden vision changes should seek medical advice promptly.
Earlier action elsewhere
The decision follows regulatory moves outside the United States. The European Medicines Agency’s safety committee concluded in June 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 users. Becker’s Hospital Review reported that Novo Nordisk has added the warning to Wegovy and Ozempic labels in Europe, and that it also appears in the UK, Denmark and Australia.
Litigation and industry position
Becker’s reported that at least 4,000 consolidated claims allege GLP-1 drugs caused vision loss. Novo Nordisk and Eli Lilly, the makers of the main products, have both disputed that the drugs cause the condition.
