US EditionFDA Calls for Removal of Suicide Warnings from Weight-Loss Drugs
The FDA's review of 91 trials with over 107,000 patients found no increased suicide risk from GLP-1 weight-loss drugs, prompting removal of related label warnings.
- On Tuesday, the U.S. Food and Drug Administration asked Novo Nordisk and Eli Lilly to remove suicide risk warnings from Wegovy, Saxenda and Zepbound after a review found no increased risk.
- Developed to treat type 2 diabetes, GLP-1 receptor agonists showed no suicidal risk in a January 2024 FDA review, which said it could not rule out that `a small risk may exist`.
- The FDA's analysis of 91 trials found no increased risk of suicidal thoughts or psychiatric side effects among 60,338 GLP-1 recipients versus 47,572 placebo recipients.
- Today's FDA action will ensure consistent messaging across labeling for all FDA-approved GLP-1 receptor agonists, while Eli Lilly and Novo Nordisk did not immediately respond to Reuters.
- The agency said the new analysis puts concerns to rest and urged those in distress to contact the Suicide & Crisis Lifeline at 988 for support.
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83 Articles
FDA wants suicide warnings removed from weight-loss medications like Zepbound, Wegovy
The Food and Drug Administration said it wants suicide warnings to be taken off some popular weight-loss medications following a comprehensive safety review.The affected products include Eli Lilly's Zepbound and Novo Nordisk's Wegovy and Saxenda.The request follows an FDA review that found no increased risk of suicidal thoughts or behavior with the use of the GLP-1 medications. The agency said the labeling is "based on reports of such events obs…
Associated Press News
Popular weight-loss drugs shouldn't carry suicide warnings, FDA says
Federal regulators are telling drugmakers to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster weight-loss drugs. The U.S.
FDA Says to Drop Suicide Warning From GLP-1 Drug Labels
(MedPage Today) -- The FDA requested that manufacturers of GLP-1 receptor agonists remove information regarding risks of suicidal behavior and ideation from drug labels following a detailed review of existing data, the agency announced on Tuesday...
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