FDA

FDA requests removal of suicide warning from GLP-1 drug labels

January 15, 2026

On January 13, 2026, FDA announced that it had asked manufacturers of GLP‑1 RAs for obesity—Saxenda, Wegovy, and Zepbound—to remove warnings about suicidal ideation and behavior. This decision follows a review of 91 placebo-controlled trials and a large claims-based cohort study, which found no increased risk of suicidal thoughts, attempts, or other psychiatric events with these drugs. Diabetes-focused GLP‑1 RAs were never subject to these warnings and remain unchanged. The update aims to harmonize labeling and reflects current evidence. Clinicians should continue monitoring patients for mood changes but can reassure them that data do not support an elevated psychiatric risk with GLP‑1 RA weight-loss therapy.

Source:

(2026, January 13). FDA. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp