FDA to require NAION risk warning for GLP-1 therapies
The FDA is requiring manufacturers of GLP-1 receptor agonist therapies to include warnings regarding the risk for nonarteritic anterior ischemic optic neuropathy, according to a drug safety communication.
The agency conducted a review following the publication of a study by Jimena Tatiana Hathaway, MD, MPH, and colleagues in JAMA Ophthalmology in 2024 that found a potential link between semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION).
The agency conducted a meta-analysis that included 126 clinical trials across GLP-1 receptor agonist development programs to assess the