As of now, the US Food and Drug Administration (FDA) has found no evidence of an association between glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications and suicidal thoughts or actions, the FDA said in a notice of preliminary findings.
Investigation of the drug class, used to treat both type 2 diabetes and obesity, was triggered by reports to the FDA Adverse Event Reporting System (FAERS).
“Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs,” the FDA says.
The FDA reviewed clinical trial data, including large outcomes studies and observational studies, and did not find an association between use of GLP-1 RAs and suicidal thoughts or actions. “However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” according to the statement.
That ongoing investigation will include an analysis of postmarketing data in the Sentinel system, a large data network of health insurance claims and patient health records. “We will communicate our final conclusions and recommendations after we complete our review or have more information to share,” FDA says.
Currently, three GLP-1 RAs are FDA-approved to treat obesity or overweight: liraglutide (Saxenda), semaglutide (Wegovy), and the dual gastric inhibitory polypeptide receptor plus GLP-1 RA tirzepatide (Zepbound). The labelling for all of them includes information about suicidal thoughts and actions, as do those of other approved weight loss medications. This information was based on events observed with older medications.
Healthcare professionals are advised to continue to follow the prescribing information for those medications. This includes monitoring and counseling patients who use GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.
The agency also encourages healthcare professionals and patients to report side effects involving GLP-1 RAs or other medicines to the FDA MedWatch program.
Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.