Ozempic, Zepbound Eye Risk Warnings: FDA Orders New Labels Over a Rare Vision-Loss Condition
The FDA is requiring every GLP-1 medicine — Ozempic, Wegovy, Mounjaro, Zepbound and the rest of the class — to warn of a potential increased risk of NAION, a rare eye condition that can cause sudden, permanent vision loss in one eye.
AUSTIN — The U.S. Food and Drug Administration on Monday ordered the makers of every GLP-1 medicine — including Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound — to add a warning about a rare eye condition that can cause sudden and sometimes permanent vision loss, Reuters reported.
The condition is non-arteritic anterior ischemic optic neuropathy, known as NAION, which occurs when blood flow to the front of the optic nerve drops. The FDA describes it as a common cause of sudden, painless decreased vision in one eye, including permanent vision loss, and says the underlying cause is not completely understood. The new information goes into the Warnings and Precautions section of each drug's labeling, and the requirement covers the whole class — semaglutide, tirzepatide, liraglutide, dulaglutide, exenatide and orforglipron products, according to Pharmacy Times.
The agency is careful about the size of the risk, and so is this report: the FDA calls it a POTENTIAL increased risk, not a proven cause. Its pooled analysis of 126 randomized trials covering 134,253 patients found 15 probable NAION cases — 10 among patients on GLP-1 drugs and 5 on placebo. Europe's medicines agency said last year the condition may affect up to 1 in 10,000 people taking semaglutide for at least a year. Listed risk factors include smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease.
Both manufacturers answered Monday. Novo Nordisk told Reuters it continues to believe the data do not establish a cause-and-effect relationship and remains confident in its medicines' benefit-risk profile; a Lilly spokesperson said the company is carefully evaluating the update and will respond to the FDA promptly. For Austin readers taking any drug in the class, the FDA's practical advice is the takeaway: report any sudden, painless loss of vision, blind spot or other visual disturbance in one eye to a health professional immediately, and seek a prompt referral to an eye specialist.
