FDA Issues Removal of Suicidal Behavior and Ideation Warning From GLP-1 RAs

Today, the US Food and Drug Administration (FDA) has requested that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. The affected GLP-1 RAs are liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound).¹

This news comes at the heels of a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

Saxenda, Wegovy, and Zepbound are all respectively approved for weight reduction in individuals with obesity or overweight. At the time of the original FDA approvals, the labeling for each of these products included information about the potential risk of SI/B in the Warnings and Precautions section. Similar information about SI/B is also included in the labeling of other types of weight loss medicines and is based on reports of such events observed with a variety of older medicines used or studied for weight loss; however, labeling for GLP-1 RA medications that are approved to improve glycemic control or other complications in patients with type 2 diabetes mellitus do not currently include information on the risk of SI/B. The FDA’s decision today will ensure more consistent messaging across the labeling for all FDA-approved GLP-1 RA medications.

The use of GLP-1 RAs in the psychiatric space has been a hot topic of discussion, as emphasized by scholars like Roger S. McIntyre, MD, FRCPC. In the Psychiatric Times July 2025 cover story by McIntyre, he emphasized the potential of these medications beyond mere weight loss: “It is a transformative possibility that GLP-1 RAs may also be capable of preventing and/or forestalling the declaration of a mental, neurologic, or substance use disorder.”²

The rationale for conceptualizing and repurposing incretin-based agents as psychiatric drugs derives from their pleiotropic effects on the pathophysiologic substrates implicated in mental disorders, shared McIntyre. Incretins (eg, GLP-1) were discovered to not only increase insulin biosynthesis and release (“an incretin effect”) but also exert protrophic and proplasticity processes in reward and cognitive control centers, thus bringing them into the psychiatric wheelhouse. Also notable, individuals with mental disorders have significantly higher rates of other comorbid medical disorders that are under investigation as potential treatment targets for GLP-1 RAs, such as binge eating disorder, polycystic ovarian syndrome, and noncirrhotic nonalcoholic steatohepatitis.

Furthermore, late last year, new research demonstrated that semaglutide shows promise in enhancing cognitive function for individuals with psychiatric disorders, particularly improving memory and overall cognitive outcomes.³

Targeting weight in general could be a factor in improving mental health outcomes, as emphasized by Psychiatric Times August 2025 cover authors Shebani Sethi, MD, and Timur Liwinski, MD, when discussing the prevalence of obesity and metabolic syndrome in schizophrenia. In their opinion, “When clinically appropriate, these treatments should be made equally accessible to individuals with [serious mental illness] as they are to those with obesity in the general population.”⁴

Have you utilized GLP-1 RAs in your psychiatric practice? Share your experience with us at PTEditor@mmhgroup.com.

References

1. FDA requests removal of suicidal behavior and ideation warning from glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. News release. January 13, 2026. Accessed January 13, 2026. https://www.fda.gov/media/190557/download?attachment

2. McIntyre RS. Transformation 2.0: the GLP-1 RAs as psychiatric medications? Psychiatric Times. 2025;42(7).

3. Walters J. Study finds semaglutide is associated with improved cognitive function in individuals with psychiatric disorders. Psychiatric Times. October 23, 2025. https://www.psychiatrictimes.com/view/study-finds-semaglutide-is-associated-with-improved-cognitive-function-in-individuals-with-psychiatric-disorders

4. Sethis S, Liwinski T. Metabolic health in schizophrenia: toward nutritional and metabolism-based strategies in psychiatry. Psychiatric Times. 2025;42(8).