FDA orders eye-loss warnings on Ozempic and Zepbound labels

Makers of blockbuster weight-loss drugs like Ozempic and Zepbound must now warn patients about a rare eye condition that can cause permanent vision loss. The FDA announced the labeling requirement Monday, saying every GLP-1 medicine currently sold carries an increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION. The condition cuts blood flow to part of the optic nerve, producing painless but reduced vision in one eye — doctors sometimes call it an eye stroke. There is no treatment for it.

The FDA's conclusion came from a sweeping review that combined reports from its Adverse Event Monitoring System with studies covering more than 134,000 patients. It found roughly six NAION cases per 100,000 people taking GLP-1 drugs each year, compared with about four per 100,000 among patients on a placebo or other diabetes medication. NAION cases have been reported across all marketed GLP-1 RA products, the agency said, and patients who have already had it face a higher risk of it coming back.

Novo Nordisk, which makes Ozempic and Wegovy, pushed back. A company spokesperson told Reuters that the data do not establish a cause-and-effect relationship and that Novo remains confident in the benefit-risk profile of its GLP-1 medicines. The Independent has reached out to Novo Nordisk for comment. Eli Lilly said patient safety is its top priority and that it is evaluating the FDA update and will respond soon, adding that anyone with side effects should talk to their doctor.

Monday's action lands after a May review from the American Academy of Ophthalmology, which found that semaglutide-based GLP-1s such as Ozempic and Wegovy may be tied to about a two-fold increase in relative risk of NAION. Drugmakers can challenge FDA safety labeling changes, but the agency decides whether the warnings go on the label.

The stakes are huge in sheer numbers: roughly 28 million Americans take GLP-1 drugs, according to a July Gallup poll. About half of patients quit within their first year, partly because of gastrointestinal side effects, per a 2025 study of 125,000 patients by scientists in Pennsylvania and the Pacific Northwest.

The FDA urged patients to watch for NAION symptoms — blurred or missing patches of vision, distorted colors, hazy spots and vision loss in one eye upon waking — and to contact a health care professional right away if they appear. The agency also flagged other risk factors, including smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease.