FDA safety warnings for GLP-1 weight-loss drugs over potential vision loss risk, Digi Mart USA News: The U.S. drug regulator, the Food and Drug Administration (FDA), said on Monday that weight-loss drugs have been associated with non-arteritic anterior ischaemic optic neuropathy (NAION), a condition that can lead to sudden, painless loss of vision in one eye, including permanent vision loss.
The new warning requirements cover all GLP-1 receptor agonists, a class of medicines widely used to treat type 2 diabetes and obesity. They include popular treatments such as Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly’s Mounjaro and Zepbound, as well as other medicines in the class.
The FDA’s assessment included an analysis of 126 clinical trials involving more than 134,000 patients. The agency also reviewed real-world data and published observational studies.
While it acknowledged limitations in the available evidence, it concluded that a potential increased risk warranted additional warnings across the drug class.
The move adds to the safety scrutiny surrounding a rapidly expanding class of medicines that has become central to the treatment of obesity and type 2 diabetes.
Last year, Europe’s medicines watchdog, the European Medicines Agency (EMA), determined that NAION should be classified as a very rare side effect of semaglutide, the active ingredient in some weight-loss medicines, affecting up to one in 10,000 patients.
