FDA has ordered a class-wide label update for all approved GLP-1 receptor agonists to add a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can lead to vision loss. The agency’s action expands upon a previously recognized NAION safety signal raised by published research and regulatory review. The FDA’s update applies to 12 marketed drugs, including Novo Nordisk’s semaglutide products (Ozempic, Wegovy) and Eli Lilly’s tirzepatide franchise (Mounjaro, Zepbound), among others. The agency cites data from an FDA assessment of 126 clinical trials across development programs, including probable NAION events in GLP-1-treated patients versus comparators. In parallel, FDA pointed to a retrospective real-world evidence analysis using its data network that found no higher NAION risk for GLP-1s compared with an alternative glucose-lowering drug class. The labeling action is framed as a warnings-and-precautions update rather than an indication restriction. Clinically, the FDA’s decision formalizes additional monitoring and patient counseling steps for prescribers and health systems managing rapidly expanding GLP-1 use across obesity and diabetes care.