News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

The U.S. Food and Drug Administration (FDA) has requested that manufacturers of certain glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications remove language regarding a risk of suicidal ideation and behavior (SI/B) from their product labeling. This follows a comprehensive review that found no evidence of increased SI/B risk associated with these commonly prescribed diabetes and weight-management drugs.

GLP-1 RA therapies—such as Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide)—include prescribing information that had previously noted potential risks of SI/B. After conducting an extensive meta-analysis of clinical trials and a large retrospective cohort study using FDA Sentinel System data, the agency determined that these medicines do increase the likelihood of suicidal thoughts or actions compared with placebo or other treatments.

In its updated safety communication, the FDA emphasized the importance of consistent and accurate messaging across all GLP-1 RA labeling and encouraged patients to continue taking their medications as prescribed. Health care professionals are advised to be prepared to address patient concerns and to refer individuals experiencing mood changes or SI/B to appropriate mental health resources.

The change reflects the agency’s commitment to ensuring that drug information reflects the most current scientific evidence, helping prescribers and patients make informed decisions while avoiding unnecessary alarm over unfounded risks.