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US FDA Requests Removal of Suicide Warnings From Weight-Loss Drugs

4 months ago 77

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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.

The request, also covering Novo’s older weight-loss drug Saxenda, follows a review by the U.S. Food and Drug Administration that found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior.

GLP-1 receptor agonists were originally developed to treat type 2 diabetes. They mimic a gut hormone that suppresses appetite, creating a feeling of fullness.

The FDA had reached similar conclusion following a preliminary review in 2024, but had acknowledged at the time that it could not rule out a small risk because of limited data.

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