The Medical Letter on Drugs and Therapeutics
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In Brief: Removal of Suicidality Warning from GLP-1 Agonists for Weight Management
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Med Lett Drugs Ther. 2026 Jan 29;68(5126):1   doi:10.58347/tml.2026.5126a
Disclosures
Principal Faculty
  • Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
Objective(s)
Upon completion of this activity, the participant will be able to:
  1. Discuss the label changes recommended by the FDA regarding the risk of suicidality with GLP-1 receptor agonists for weight management.

The FDA has requested the removal of the suicidal behavior and ideation warning from the labels of the three glucagon-like peptide-1 (GLP-1) receptor agonists approved for chronic weight management: liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The warning was initially included in the labels of these drugs based on an increased risk of suicidal behavior and ideation observed with older drugs for weight management.1

Liraglutide, semaglutide, and tirzepatide are also marketed under different brand names for other indications, including treatment of type 2 diabetes, but the suicidality warning is not included in these labels.2 Removal of the warning was based on the results of analyses conducted by the FDA. In a meta-analysis of 91 controlled trials that included 107,901 patients, use of a GLP-1 receptor agonist was not associated with an increased risk of suicidal behavior/ideation or other psychiatric adverse events compared to placebo. An analysis of published observational and pooled studies also found that use of these drugs was not associated with an increased risk of suicidal behavior or ideation. A retrospective study of claims data and health records from the FDA Sentinel System that included 2,243,138 new users of GLP-1 receptor agonists or sodium-glucose cotransporter-2 (SGLT2) inhibitors found that use of a GLP-1 receptor agonist was not associated with an increased risk of intentional self-harm compared to use of an SGLT2 inhibitor.1,3 Similar results have been observed in other studies.4,5

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