FDA warns of rare eye condition causing blindness from GLP-1 weight loss medications
Summary
The FDA is requiring GLP-1 drug makers to add a warning about a possible increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause sudden, lasting vision loss. The agency found 15 probable cases in a review of clinical trials and said the evidence shows a potential risk, but does not establish that the drugs cause the condition.Key Facts
- The required warning applies to all marketed GLP-1 receptor agonists, including Ozempic, Wegovy, Mounjaro, Zepbound and Soliqua.
- NAION reduces blood flow to the optic nerve and can cause sudden, painless vision loss in one eye.
- The FDA reviewed 126 clinical trials involving more than 134,200 patients.
- The review identified 15 probable NAION cases: 10 among GLP-1 users and five among patients receiving placebo.
- The FDA reported 6.4 NAION cases per 100,000 person-years among GLP-1 users, compared with 3.8 among placebo or other glucose-lowering medication users.
- The FDA began assessing the possible link after a 2024 study in JAMA Ophthalmology reported an increased risk among GLP-1 users.
- Novo Nordisk said the data do not establish a cause-and-effect relationship and that it continues to monitor the medicines' safety.
- There is currently no treatment that can reverse vision loss caused by NAION.
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