FDA warns GLP-1 drugs may pose risk of rare condition that causes vision loss
Summary
The FDA will require makers of GLP-1 drugs, including Ozempic, Wegovy, Zepbound and Mounjaro, to add a warning about a possible risk of NAION, a rare condition that can cause sudden, sometimes permanent vision loss. The cause of any possible link is unknown, and studies have reported mixed results, so the evidence does not establish that the drugs cause the condition.Key Facts
- The FDA announced the label-warning requirement in a drug safety communication Monday.
- NAION occurs when restricted blood flow damages the optic nerve.
- The American Academy of Ophthalmologists estimates NAION affects about two to 10 people per 100,000 in the general population.
- Diabetes, cardiovascular disease, high blood pressure, high cholesterol, metabolic syndrome and sleep apnea are risk factors for NAION.
- A 2024 Harvard study reported higher NAION rates among patients taking semaglutide, but it had limitations, including drawing patients from one referral center.
- Later studies produced mixed findings; a meta-analysis of 78 trials found a higher NAION risk with semaglutide, based on only five trials that reported NAION events.
- A database study of 37.1 million patients with diabetes generally found no link between semaglutide and NAION, with an increased risk appearing only in a specific comparison and analysis.
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