The FDA has not found an association between GLP-1 agonists and suicidal behavior.

The US Food and Drug Administration (FDA) has found no association between use of GLP-1 agonist drugs and suicidal behavior. The regulator analyzed reports of suicidal tendencies after taking medications for obesity and diabetes, and also examined data from clinical studies.

The FDA, in a preliminary evaluation, did not find an association between glucagon-like peptide-1 (GLP-1) receptor agonists and increased suicidality. This was reported by the Pharmaceutical Bulletin with reference to the website of the American regulator.

A detailed analysis of reports of suicidal behavior after taking drugs was carried out and the conclusion was made that there was no “clear relationship”. GLP-1 agonists are indicated for the treatment of diabetes and obesity. These include FDA-registered drugs Wegovy, Novo Nordisk’s Ozempic (semaglutide), and Eli Lilly’s Mounjaro and Zepbound (tirzepatide).

Data from clinical studies of GLP-1 agonists were also examined, which do not demonstrate an association between the drugs and the occurrence of suicidality in patients. However, the regulator “cannot definitively rule out the possibility that a negligible risk exists” due to the few cases of increased suicidality in patients taking drugs in this class.

Previously, the journal Nature Medicine published the results of a large study of drugs for obesity and diabetes. The risk of suicidal behavior was lower among patients taking GLP-1 agonists than among those taking other medications for obesity and diabetes.

The European Medicines Agency (EMA) has asked pharmaceutical companies for data on the safety of GLP-1 drugs. The review comes following reports from Iceland’s regulator of suicidal ideation and self-harm among patients taking anti-obesity and diabetes medications.

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