The U.S. FDA says it has not found evidence that a class of medicines used to treat type 2 diabetes and obesity causes suicidal thoughts or actions. The medicines, known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs), are increasingly prescribed for blood sugar control and weight management.

 

“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 (GLP-1 RAs; see the list in Table 1 below),” the agency said. “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.”

 

Over the past several months, FDA reviewers examined reports in its Adverse Event Reporting System (FAERS). The agency noted that limited information and other potential factors in the reports made it impossible to demonstrate a clear link with GLP-1 RA use. Reviews of clinical trials, including large outcome and observational studies, also found no association with suicidal thoughts or actions.

 

However, the FDA cautioned that because the number of reported cases was small, a small risk cannot be completely ruled out. The agency is continuing to study the issue through a meta-analysis of clinical trials and postmarketing data in its Sentinel System.

 

“Patients should not stop taking GLP-1 RAs without first consulting your health care professional, as stopping these medicines may worsen your condition,” the FDA warned. 

 

The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts, consistent with other weight-loss medicines. Health care professionals are advised to monitor patients and report any unusual mood changes.

 

GLP-1 RAs, first approved in 2005, mimic a hormone in the intestines that helps control blood sugar and regulate appetite. Some also slow digestion to help patients feel full longer. These drugs are now widely used for type 2 diabetes and weight loss.