The FDA is requiring safety labeling changes for GLP-1 receptor agonists over a potential increased risk of a rare eye condition that can cause vision loss.
The agency is requiring drugs including Eli Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy to add information about non-arteritic anterior ischemic optic neuropathy, or NAION, to the warnings and precautions section of their labeling, according to a Nov. 9 drug safety communication. NAION can cause sudden, painless vision loss in one eye, which can be permanent. The FDA said it evaluated clinical trial, animal and postmarket data, including observational studies and case reports, in reaching its decision.
The action follows months of scrutiny over a potential link between GLP-1 drugs and NAION. Novo Nordisk added a NAION warning to European labels for Wegovy and Ozempic in June, stating the condition may occur in up to 1 in 10,000 patients. The warning also appears on labels in the U.K., EU, Denmark and Australia. The warning had been absent from U.S. labels, and the American Academy of Ophthalmology had said available evidence did not support a blanket U.S. warning.
The FDA’s action also comes amid mounting litigation. As of September, at least 4,000 consolidated claims alleged GLP-1 drugs caused vision loss. In the first wave of those cases, dozens of patients sued Novo Nordisk and Eli Lilly over NAION. Both drugmakers have disputed a causal link. A Novo Nordisk spokesperson said in September that a causal relationship between GLP-1 receptor agonists, including semaglutide, and NAION could not be confirmed based on the totality of the data.
Research has also found an association between semaglutide and NAION. A 2025 study of nearly 175,000 patients with diabetes treated with semaglutide found the risk of NAION more than doubled after two years of treatment compared with patients taking diabetes medications from other classes. In 2024, a JAMA Ophthalmology study also found patients taking semaglutide may be at increased risk of the condition.
