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Update on FDA's Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines Approved for Type 2 Diabetes and Obesity

    Basic Details
    Communication Type
    Safety Communication
    FDA Center
    Medical Product
    glucagon-like peptide-1 (GLP-1) receptor agonists
    Health Outcome(s)
    intentional self-harm

    The U.S. Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs; see the list in Table 1 here). These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.

    Over the last several months, we have conducted detailed reviews of reports of suicidal thoughts or actions received in 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. Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of 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.

    Additional evaluations include a meta-analysis of clinical trials across all GLP-1 RA products and an analysis of postmarketing data in the Sentinel System. A meta-analysis is a large, combined analysis of findings from clinical trials. Sentinel is a very large data network that contains health insurance claims and patient health records that can be used to investigate safety questions about FDA-regulated products. We will communicate our final conclusions and recommendations after we complete our review or have more information to share.