FDA orders vision-loss warning on Ozempic, Zepbound and other GLP-1 drugs

The U.S. Food and Drug Administration (FDA) on Monday ordered the makers of all GLP-1 drugs, such as Ozempic and Zepbound, to warn about a possible increased risk of a rare eye disease that can cause permanent vision loss.

The warning concerns non-arteritic anterior ischemic optic neuropathy (NAION), a condition that causes sudden, painless vision loss in one eye, sometimes in both, when blood flow to the optic nerve is reduced. The agency said it did not determine that the drugs cause the disease, but found signals of a possible increased risk.

The review, prompted in part by a study published in 2024 in JAMA Ophthalmology, analyzed 126 clinical trials with 134,253 patients and found 15 probable cases of NAION: 10 among people taking GLP-1 drugs and five among those who received a placebo. The rate was 6.4 cases per 100,000 treated patients, compared with 3.8 in the comparison groups.

The measure covers a dozen medications, including Ozempic, Wegovy, Mounjaro, Zepbound and Trulicity. In Europe, semaglutide labels have warned since June that the condition may affect up to 1 in 10,000 people. The FDA asked patients to report any sudden vision loss right away and doctors to refer them to an eye specialist. Drugmakers Novo Nordisk and Eli Lilly have denied a significant link.

Photo: Reuters

Source: FDA