The Food and Drug Administration (FDA) this week requested that manufacturers of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for weight loss remove warnings that the drugs may increase the risk of suicidal ideation and behavior.The affected medications are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).
Why It’s Relevant
When these three medications were approved by the FDA to treat obesity, their labels were required to include a warning that they could increase the risk of suicidal ideation and behaviors (SI/B)—a warning also included in the labeling of other types of weight-loss medications due to postmarketing reports of such events. However, the warning about SI/B is not required for GLP-1 drugs solely approved to improve blood-sugar control or other complications in patients with type 2 diabetes.
By the Numbers
- In January 2024, the FDA stated that a review of patient reports and clinical trials did not reveal an association between GLP-1 RAs and SI/B. However, because of the small number of total events, the agency couldn’t definitively rule out a small risk.
- Since then, the FDA conducted a meta-analysis of 91 placebo-controlled GLP-1 RA trials, which included 107,910 patients. The results did not show an increased risk for SI/B or for other relevant psychiatric adverse events such as anxiety, depression, irritability, or psychosis.
- Additionally, the FDA used health care claims data from 2015 to 2023 to compare the risk of intentional self-harm between GLP-1 RAs and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in more than 2.2 million patients with type 2 diabetes. The analysis did not reveal an increased risk of intentional self-harm in GLP-1 RA users compared with SGLT2i users after controlling for confounders.
What Else to Know
Researchers are increasingly looking into the use of GLP-1 drugs within psychiatry. Semaglutide, for example, has been linked to a lower risk of Alzheimer’s disease in adults with type 2 diabetes compared with other diabetes drugs.
Takeaway Message
“Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” the FDA stated. “Health care professionals should be prepared to discuss with patients that FDA has found no increased risk [of SI/B] after conducting a comprehensive review of the available data. If individuals disclose that they are experiencing SI/B, refer them to mental health professionals for evaluation.”
Related Information
Source
FDA requests removal of suicidal behavior and ideation warning from glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. FDA Drug Safety and Availability website. Published January 13, 2026.
(Image: Getty Images/iStock/SweetBunFactory)
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