FDA orders eye condition warning on GLP-1 drugs such as Ozempic and Wegovy

The US Food and Drug Administration (FDA) is requiring makers of Ozempic, Wegovy and similar drugs to warn of a rare eye condition that can cause vision loss, according to Medical Xpress. BBC News also reported that manufacturers were ordered to add the warnings. The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION.

NAION happens when blood flow drops to part of the optic nerve. It usually affects one eye, and vision loss comes on suddenly and without pain. In some cases the loss is permanent. The FDA said the risk is rare but wants patients and doctors to know the warning signs. Ars Technica reported that the risk appears small and the data are mixed.

The new label warning covers every drug in the GLP-1 class, including Ozempic, Wegovy, Mounjaro, Zepbound and Trulicity. Millions of people use these drugs to manage type 2 diabetes or to lose weight. Some are also approved to lower the risk of heart attack and stroke, or to treat sleep apnea and certain kidney and liver diseases.

The FDA began looking into the issue after a 2024 study raised concerns about semaglutide, the active ingredient in Ozempic and Wegovy. It reviewed other studies, real-world patient records and reports of side effects. Across 126 clinical trials, NAION occurred in about six of every 100,000 GLP-1 users each year. Among people taking a placebo or a different diabetes drug, about four per 100,000 had it each year.

The agency said animal studies did not show how the drugs might cause the problem. Diabetes, high blood pressure and sleep apnea also raise the odds of NAION, which makes the drugs' exact role hard to determine. The FDA nevertheless concluded there is a potential increased risk.

Patients who notice sudden painless vision loss in one eye, blurry or missing areas of sight, faded or distorted colours, or hazy spots in the centre of vision should call their health care provider right away. Doctors are urged to send patients with a suspected case to an eye specialist promptly.

People who have already had NAION should talk with their doctor about whether to keep taking their GLP-1 medication, because having it once in one eye raises the chance it will strike the other. The FDA told doctors to consider stopping the drug in patients who develop the condition unless its benefits clearly outweigh the risk.