FDA Mandates Vision Loss Warning on GLP-1 Drug Labels
The FDA issued a Nov. 9 drug safety communication requiring labeling changes for GLP-1 receptor agonists, including Eli Lilly's Mounjaro and Zepbound and Novo Nordisk's Ozempic and Wegovy, to add warnings about non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause sudden, permanent vision loss in one eye. The FDA said it based the decision on clinical trial, animal and postmarket data, including observational studies and case reports. Novo Nordisk had already added a similar warning to European labels in June, but the warning had been absent from U.S. labels, and the American Academy of Ophthalmology previously said evidence did not support a blanket U.S. warning. The action comes as at least 4,000 consolidated claims allege GLP-1 drugs caused vision loss, and both drugmakers dispute a causal link.