US FDA asks drugmakers to remove suicide warnings from weight-loss drugs

The U.S. Food and Drug Administration asked manufacturers to remove label warnings about suicidal thoughts from GLP-1 weight-loss drugs after a review found no evidence of an increased risk in clinical trials.

The U.S. health regulator asked drugmakers to remove label warnings about a potential risk of suicidal thoughts from GLP‑1 weight‑loss drugs. The request covered Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. The FDA said its review found no evidence linking GLP‑1 receptor agonists to an increased risk of suicidal thoughts or behavior. GLP‑1 receptor agonists were developed to treat type 2 diabetes and work by mimicking a gut hormone that suppresses appetite. Key points: - The FDA asked manufacturers to remove label warnings about suicidal thoughts from widely used GLP‑1 weight‑loss drugs, including Wegovy, Zepbound and Saxenda. - Further analyses of placebo-controlled clinical trials did not show an increased risk of suicidal thoughts or behavior versus placebo, according to the agency. - The review covered 91 trials and 107,910 patients, with 60,338 receiving a GLP‑1 drug and 47,572 receiving placebo. - The FDA had reached a similar conclusion in a 2024 preliminary review but at that time said a small risk could not be ruled out because of limited data. - Eli Lilly and Novo Nordisk did not immediately respond to Reuters' requests for comment. Summary: The FDA's request follows its further analysis and removes a previously noted potential risk after examining a large set of trials. The review addressed nearly 108,000 trial participants and spans several branded products. Undetermined at this time.