FDA requests removal of suicide warnings from weight-loss drug labels.

The FDA asked manufacturers to remove label warnings about suicidal thoughts from GLP-1 weight-loss drugs after a review found no evidence of increased risk; the review covered 91 trials with about 107,910 participants.

The U.S. Food and Drug Administration asked drugmakers to remove label warnings about potential suicidal thoughts from several GLP-1 weight-loss drugs, including Wegovy, Zepbound and Saxenda. The request follows an FDA review that reported no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior. GLP-1 drugs were developed to treat type 2 diabetes and work by mimicking a gut hormone that reduces appetite. The agency had reached a similar conclusion in a preliminary 2024 review but re-examined a larger set of trials to clarify the findings. Key findings: - The FDA analyzed 91 placebo-controlled clinical trials involving 107,910 patients, including 60,338 who received a GLP-1 drug and 47,572 who received placebo. - The analyses did not show an increased risk of suicidal thoughts or suicide-related behavior versus placebo. - The review also did not find evidence of increased risk for other psychiatric side effects such as anxiety, depression, irritability or psychosis compared with placebo. - The regulator’s request covers widely used GLP-1 weight-loss medicines named in reports, and manufacturers had not immediately responded to requests for comment. Summary: The FDA’s request reflects its finding of no evidence of increased suicide risk associated with GLP-1 treatments based on the reviewed trials. The agency had earlier issued a preliminary conclusion in 2024 but reassessed the data with a larger trial set. Drugmakers had not immediately replied to media requests and no timetable for label changes was provided. Undetermined at this time.