FDA Requests Removal of Suicidal Ideation Warning From GLP-1 Receptor Agonist Labeling

The US Food and Drug Administration has requested that drug application holders remove information regarding suicidal ideation and behavior from the labeling of certain glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications used for weight reduction, citing findings from a comprehensive safety evaluation that did not identify an increased risk associated with use of the drug class.¹

In a Drug Safety Communication released January 13, 2026, the FDA reported that its review found no evidence linking certain GLP-1 RAs to suicidal ideation or behavior. The affected GLP-1 RAs are liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound).¹

The action updates the agency’s January 2024 communication, which followed postmarketing reports of suicidal thoughts or actions in persons receiving GLP-1 RAs. At that time, the FDA noted uncertainty due to the small number of events observed in individual trials and initiated additional analyses to further assess risk.²

According to the FDA, labeling for GLP-1 RAs approved to improve glycemic control or other complications in individuals with type 2 diabetes mellitus does not currently include information on suicidal ideation or behavior. The agency stated that its current request is intended to ensure consistent messaging across labeling for all approved agents in the class.¹

To evaluate safety, the FDA conducted a comprehensive meta-analysis of placebo-controlled clinical trials across GLP-1 RA development programs. The analysis included 91 trials enrolling 107 910 participants, of whom 60 338 received a GLP-1 RA and 47 572 received placebo. The results did not show an increased risk of suicidal ideation or behavior or of other psychiatric adverse events, including anxiety, depression, irritability, or psychosis.¹

The agency also performed a retrospective cohort study using administrative claims data from the FDA Sentinel System. The analysis compared intentional self-harm among new users of GLP-1 RAs and sodium-glucose cotransporter 2 inhibitors in persons with type 2 diabetes. The study included 2 243 138 individuals treated between October 1, 2015, and September 20, 2023. After adjustment for baseline confounders, the FDA reported no increased risk of intentional self-harm in participants initiating GLP-1 RAs compared with those starting sodium-glucose cotransporter 2 inhibitors, including among those with both type 2 diabetes and obesity.¹

Based on the totality of evidence, including clinical trials, observational studies, pooled analyses, and postmarketing data, the FDA concluded that the findings do not support a causal relationship between GLP-1 RA use and suicidal ideation or behavior.¹

The agency advised that individuals should continue taking their medications as prescribed and discuss any concerns with their health care professionals. Clinicians are encouraged to inform patients that the FDA did not identify an increased risk after comprehensive review and to refer individuals reporting suicidal ideation or behavior for mental health evaluation, consistent with standard clinical practice.¹

References:

1. US Food and Drug Administration. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications. January 13, 2026. Accessed January 13, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp?utm_medium=email&utm_source=govdelivery
2. US Food and Drug Administration.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. January 11, 2024. Accessed January 13, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type