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FDA 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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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.
·United States
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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...
·New York, United States
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US FDA requests removal of suicide warnings from weight-loss drugs
The U.S. health regulator on Tuesday asked drugmakers to remove label warnings about a potential risk of suicidal thoughts from widely used GLP-1 weight-loss drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
·Atlanta, United States
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Coverage Details
Total News Sources69
Leaning Left11Leaning Right6Center39Last UpdatedBias Distribution70% Center
Bias Distribution
- 70% of the sources are Center
70% Center
L 19%
C 70%
11%
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