FDA orders new warning on GLP-1s over rare eye condition linked to sudden blindness
The Food and Drug Administration said Monday that GLP-1 drugmakers must add a warning label about a rare eye condition that can cause sudden blindness.The condition, called nonarteritic anterior ischemic optic neuropathy, or NAION, affects the optic nerve, which carries signals from the eye to the brain.
When blood flow to the nerve is reduced or blocked, it can cause sudden vision loss.The condition is permanent with no known treatment.
The FDA said “there is a potential increased risk of rare NAION” in people taking GLP-1 drugs.The agency’s requirement applies to all GLP-1s, including Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound, as well as several older GLP-1 diabetes medications.Spokespeople for both Novo Nordisk and Eli Lilly said patient safety is their top priority.Previous research has found that GLP-1 use may increase the risk of NAION, and Lilly has said it was aware of studies on the potential link.The FDA said it began looking into a possible link after a 2024 study published in JAMA Ophthalmology that found diabetes patients prescribed semaglutide were four times as likely to develop NAION as those not prescribed the drug.The agency said it reviewed reports of side effects submitted to its adverse event monitoring system and analyzed data from multiple clinical trials.
Cases of NAION have been reported for all currently marketed GLP-1 drugs, the FDA found.However, FDA scientists were not able to identify a mechanism for how the drugs could increase the risk of the eye condition.
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