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FDA concludes GLP-1 drugs do not cause suicidal thoughts, asks makers to drop the warning

Regulatory 87/100
January 14, 2025↗ source

After a multi-year pharmacovigilance review triggered by a 2024 WHO VigiBase disproportionality signal, the FDA concluded that GLP-1 receptor agonists (semaglutide, tirzepatide, liraglutide, and related drugs) do not increase the risk of suicidal ideation or behavior and formally requested manufacturers remove the related warning labeling. The finding aligns with a parallel European Medicines Agency (EMA) review that likewise found no causal link. Large 2025 cohort studies and meta-analyses published in BMJ and other journals consistently showed no elevated suicide risk versus comparator drugs. The episode illustrates how spontaneous-report databases can flag signals that controlled analyses later rule out.

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