GLP-1s not linked to suicidal thoughts: Early FDA review

On Jan. 11, the FDA said it has not found a causal link between glucagon-like peptide-1 receptor agonists, such as Ozempic and Mounjaro, and suicidal thoughts.

The agency recently announced it was investigating the potential side effect alongside reports of hair loss and aspiration. Over the last few months, the FDA reviewed reports of suicidal thoughts or actions that were sent to the agency's Adverse Event Reporting System, which can be limited in scope. 

A preliminary analysis of the FAERS data "did not demonstrate a clear relationship" between GLP-1s and a risk of suicidal thoughts and actions, the FDA said, and clinical trials have found similar results.

"However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, the FDA cannot definitively rule out that a small risk may exist; therefore, the FDA is continuing to look into this issue," the agency said.

The European Medicines Agency began reviewing the same potential side effect in mid-2023 after Icelandic patients reported thoughts of suicide and self-harm.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars