FDA Preliminary Evaluation Finds No Clear Link Between GLP-1 Drugs and Suicidal Thoughts, Cautions on Small Risk
The US Food and Drug Administration (FDA) has provided a preliminary evaluation of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), a class of medicines used to treat type 2 diabetes or to help those with obesity or who are overweight to lose weight.
“Our preliminary evaluation has not found evidence that the use of these medications causes suicidal thoughts or actions,” said the FDA in a Drug Safety Communication.
Which key findings impact your psychiatric practice?
No Clear Evidence of Causation
The FDA's preliminary evaluation, based on detailed reviews of reports of suicidal thoughts and actions received in the FDA Adverse Event Reporting System (FAERS) and of clinical trials, did not find conclusive evidence linking the use of GLP-1 RAs to suicidal thoughts or actions.
Acknowledgment of a Possible Small Risk
The FDA cautions that “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.” The FDA is conducting additional evaluations, including a meta-analysis of clinical trials and an analysis of postmarketing data, to investigate further.
Health Care Professional Monitoring and Patient Awareness
The FDA recommends that health care professionals closely monitor patients using GLP-1 RAs for any signs of new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior. Patients are advised not to discontinue the medication without consulting their health care professional, as abruptly stopping these medicines may worsen their condition. The prescribing information for GLP-1 RAs already contains information on the risk of suicidal thoughts and actions, and health care professionals should follow these guidelines when treating patients.
The FDA committed to communicating its final conclusions and recommendations as the review progresses and encouraged clinicians and patients to report side effects involving GLP-1 Ras or other medicines to the FDA MedWatch Program.
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