The request applies to GLP-1 RAs approved for obesity, including Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.
- The decision follows a comprehensive review that found no link between GLP-1 RA use and suicidal ideation or behavior.
- The agency conducted a large meta-analysis of 91 placebo-controlled clinical trials involving 107,910 patients.
- The FDA also reviewed data from more than 2.2 million patients using healthcare claims and found no higher risk of self-harm among GLP-1 users versus patients taking other diabetes drugs.
The U.S. Food and Drug Administration (FDA) on Tuesday asked drugmakers to remove warnings about suicidal thoughts and behavior from the labels of certain popular weight-loss medications after finding no evidence of increased risk.
The request applies to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for obesity, including Novo Nordisk’s (NVO) Wegovy and Saxenda, and Eli Lilly’s (LLY) Zepbound.
The decision follows a comprehensive review that found no link between GLP-1 RA use and suicidal ideation or behavior.
These warnings were originally included as a precaution, based largely on reports tied to older weight-loss drugs rather than GLP-1 therapies specifically. Notably, GLP-1 medications approved for type 2 diabetes have never carried such warnings, and the FDA said the change will ensure consistent labeling across the drug class.
FDA’s Analysis
The agency conducted a large meta-analysis of 91 placebo-controlled clinical trials involving 107,910 patients. The analysis found no increased risk of suicidal thoughts, self-injurious behavior (SI/B), or other psychiatric adverse events such as depression or anxiety.
The FDA also reviewed data from more than 2.2 million patients using healthcare claims and found no higher risk of intentional self-harm among GLP-1 users compared with patients taking other diabetes drugs.
The findings reaffirm results from a preliminary FDA review released in early 2024 and align with conclusions from a separate UK review in the same year. The Medicines and Healthcare products Regulatory Agency (MHRA) had found no evidence linking weight-loss and diabetes drugs to suicides or suicidal thoughts.
At the time of writing, LLY and NVO stocks were trading 0.1% and 0.2% lower, respectively. Retail sentiment for both stocks was in the ‘bullish’ territory.
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