Drugmakers welcome FDA’s GLP-1RA suicide warning removal request

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/drugmakers-welcome-fdas-glp-1ra-s...

Published: Wed, 14 Jan 2026 16:54:59 +0000

Drug manufacturers welcome the US FDA's request to remove the warning about suicidal thoughts and behavior from the package leaflets of GLP-1RA drugs.[1] This request comes after a two-year review of reported associations between GLP-1RAs and psychiatric adverse events.[1] The FDA analyzed reports of suicidal thoughts or actions in the FAERS Adverse Event Reporting System, but the data did not show a clear association with GLP-1RA use due to limited information and other confounding factors.[2] Likewise, a review of clinical trials, including large outcome studies and observational studies, found no association between GLP-1RAs and the occurrence of suicidal thoughts or actions.[2] Given the small number of such events in both the GLP-1RA and control groups, the FDA cannot rule out a small risk and continues to investigate.[2] Additional evaluations include a meta-analysis of clinical trials of all GLP-1RA products and an analysis of post-marketing data in the Sentinel system.[2] Healthcare professionals should continue to monitor patients taking GLP-1RAs for new or worsening depression, suicidal ideation, or mood changes, according to the package insert.[2]