RELEASE
ARTICLE
The FDA has requested the removal of the suicidal behavior and ideation warning from the labels of the 3 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 weight loss drugs.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 healthcare claims data and patient 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
- FDA Drug Safety Communication. FDA requests removal of suicidal behavior and ideation warning form glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. January 13, 2026. Available at: https://bit.ly/4rd9VSP. Accessed January 29, 2026.
- Drugs and devices for weight management. Med Lett Drugs Ther 2025; 67:121.
- FDA Drug Safety Communication. Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity. Available at: https://bit.ly/46iv5qu. January 13, 2026. Accessed January 29, 2026.
- J Bezin et al. Suicide and suicide attempt in users of GLP-1 receptor agonists: a nationwide case-time-control study. EClinicalMedicine 2024; 80:103029. doi:10.1016/j.eclinm.2024.103029
- H Tang et al. Glucagon-like peptide-1 receptor agonists and risk for suicidal ideation and behaviors in U.S. older adults with type 2 diabetes: a target trial emulation study. Ann Intern Med 2024; 177:1004. doi:10.7326/m24-0329
