FDA orders new vision-loss warnings on Ozempic, Wegovy, Zepbound and other GLP-1 drugs

WASHINGTON (Nov. 9) — The makers of the country's most popular diabetes and weight-loss drugs will have to add a new warning to their labels about a rare eye condition that can cause permanent vision loss, the Food and Drug Administration said Monday.

In a drug safety communication, the agency said it is requiring every company that holds an approval for a GLP-1 receptor agonist to add information about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, known as NAION, to the warnings and precautions section of its labeling. The condition can bring on sudden, painless loss of vision in one eye.

The requirement covers Novo Nordisk's Wegovy and Ozempic and Eli Lilly's Mounjaro, Zepbound and Foundayo, Bloomberg Law reported, along with the rest of the drug class.

The FDA based the decision on a pooled analysis of 126 randomized clinical trials with more than 134,000 patients. People taking a GLP-1 drug had 6.4 NAION cases per 100,000 person-years, compared with 3.8 cases for those on a placebo or a different glucose-lowering drug. The agency also reviewed real-world data and published observational studies and, while it acknowledged limits in the evidence, concluded the potential risk warranted a warning across the whole class, Euronews reported.

The FDA told patients to contact a health care professional right away if they notice sudden vision loss in one eye, blurred or missing parts of their vision, or distorted colors, symptoms it said people may first notice when they wake up. Patients who have had NAION should talk with their doctor about whether to keep taking the medicine. The agency said the condition is caused by reduced blood flow to the front of the optic nerve, and that smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease may raise the risk.