The U.S. Food and Drug Administration (FDA) on Tuesday requested that drugmakers remove label warnings about potential suicidal thoughts from widely used GLP-1 weight-loss medications, including Novo Nordisk’s Wegovy and Saxenda, as well as Eli Lilly’s Zepbound.
The decision comes after the FDA completed a comprehensive review of clinical trial data and found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior.
Originally developed to treat type 2 diabetes, GLP-1 receptor agonists mimic a gut hormone that helps suppress appetite and promotes a feeling of fullness, making them increasingly popular as weight-loss treatments.
The agency had reached a similar preliminary conclusion in 2024 but had noted that limited data at the time prevented it from fully ruling out a small risk. Tuesday’s announcement follows a more extensive analysis of 91 placebo-controlled clinical trials, encompassing 107,910 patients—60,338 who received a GLP-1 drug and 47,572 who received a placebo.
The review confirmed that patients taking GLP-1 medications did not face a higher risk of suicidal thoughts, behavior, or other psychiatric side effects such as anxiety, depression, irritability, or psychosis compared with those taking a placebo.
Eli Lilly and Novo Nordisk did not immediately respond to requests for comment.
