Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
The 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 (or GLP-1 RAs). These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. On January 11, 2024, we are announcing that 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. 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. We will communicate our final conclusions and recommendations after we complete our review or have more information to share.
The current prescribing information for the GLP-1 RAs approved to treat patients with obesity or overweight contains information about the risk of suicidal thoughts and actions. This information is also included in the labels of other types of weight loss medicines and is based on reports of such events observed with a variety of older medicines used or tested for weight loss.
Consistent with the prescribing information for these medications, health care professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior. Health care professionals should consult the prescribing information when treating patients with these medications.
Side effects involving GLP-1 RAs should be reported to FDA’s MedWatch reporting program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.