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UNCAPTIONED: US FDA Asks Drugmakers To Remove Suicide Warnings From Weight-Loss Drugs

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US FDA Asks Drugmakers To Remove Suicide Warnings From Weight-Loss Drugs. The U.S. Food and Drug Administration is asking pharmaceutical companies to remove warnings about suicidal thoughts from labels on widely used GLP-1 weight-loss drugs. The request applies to medications including Novo Nordisk’s Wegovy and Saxenda, as well as Eli Lilly’s Zepbound. The move follows an FDA review that found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior. These drugs were originally developed to treat type 2 diabetes and work by mimicking a gut hormone that suppresses appetite and increases feelings of fullness. The FDA says it analyzed data from 91 placebo-controlled clinical trials, involving more than 107,000 patients. The results showed no higher risk of suicidal thoughts or other psychiatric side effects such as anxiety, depression, irritability, or psychosis compared with placebo. The regulator had reached a similar conclusion in a preliminary review last year but said more data was needed at the time. With this expanded analysis now complete, the FDA says the suicide warnings are no longer supported by the evidence.

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