FDA Orders a Vision-Loss Warning on Ozempic, Wegovy, Zepbound and Other GLP-1 Drugs
The Food and Drug Administration is requiring makers of all GLP-1 drugs, including Ozempic, Wegovy, Mounjaro and Zepbound, to warn that the medicines may raise the risk of a rare eye condition that can cause permanent vision loss.
The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. It cuts blood flow to the front of the optic nerve and can cause sudden, painless vision loss in one eye, the FDA said in a Nov. 9 safety notice.
The agency said patients may first notice the problem when they wake up. Symptoms include blurred or missing patches of vision, such as blind spots or tunnel vision, colors that look distorted, and hazy central vision.
Patients who notice any of those symptoms should contact their health care provider right away, the FDA said. Anyone who has had an NAION event should talk with a doctor about whether to keep taking the drug.
The agency did not tell patients to stop their medicines. It told doctors to “consider discontinuing” a GLP-1 drug in patients who develop NAION “unless the benefits of treatment clearly outweigh the risk.”
The warning rests on an FDA review of 126 clinical trials covering more than 134,000 patients. It found 6.4 cases per 100,000 patient-years among GLP-1 users, compared with 3.8 among patients on a placebo or other glucose-lowering drugs, CNBC reported.
That added up to 15 probable cases, 10 among GLP-1 patients and five among those on placebo. The FDA said a causal link has not been established, and NAION remains rare.
The risk picture is muddied because NAION’s risk factors, including diabetes, high blood pressure, sleep apnea and smoking, are common among people taking these drugs, Ars Technica reported. Once it strikes one eye, the other eye faces a higher risk.
Ars Technica said the American Academy of Ophthalmology holds that “there may be an association” but that “causation has not been established.” Most studies so far have focused on semaglutide, the ingredient in Ozempic and Wegovy.
Novo Nordisk, which makes Ozempic and Wegovy, said it “continues to believe the data do not establish a cause-and-effect relationship,” according to CNBC. Eli Lilly, maker of Mounjaro and Zepbound, said it is “carefully evaluating the update.”
Lilly also said the FDA’s notice “does not reference any findings specific to Lilly medicines,” The Washington Post reported. European regulators flagged the risk for semaglutide in June 2025, and Britain followed in February.
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