FDA Review Finds No Association Between GLP-1 Drugs and Suicidal Ideation

A preliminary FDA review of GLP-1 drugs used to treat patients with type 2 diabetes or obesity finds there is no evidence they cause suicidal thoughts or actions, regulators said in a safety communication.¹ But because the risk cannot be ruled out, regulators will continue to evaluate these drugs.

Regulators have over the last few months reviewed the reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS) related to these drugs (see below for list of drugs that have been evaluated for this risk). Because the information provided was often limited and because these events can be influenced by other potential factors, regulators said there wasn’t a clear link with the use of GLP-1.

They also reviewed results of clinical trials, including large outcome studies and observational studies and did not find an association between use of GLP-1 and the occurrence of suicidal thoughts or actions.

Regulators will conduct additional evaluations, including of meta-analysis of clinical trials across all GLP-1 products and also analyze postmarketing data in the Sentinel System. Sentinel is a large data network that contains health insurance claims and patient health records.

FDA-Approved GLP-1 Drugs

• Adlyxin (lixisenatide) Type 2 diabetes
• Bydureon BCise (exenatide) Type 2 diabetes
• Byetta (exenatide) Type 2 diabetes
• Mounjaro (tirzepatide) Type 2 diabetes
• Ozempic (semaglutide) Type 2 diabetes
• Rybelsus (semaglutide) Type 2 diabetes
• Saxenda (liraglutide) Obesity/overweight
• Soliqua (lixisenatide + insulin glargine) Type 2 diabetes
• Trulicity (dulaglutide) Type 2 diabetes
• Victoza (liraglutide) Type 2 diabetes
• Wegovy (semaglutide) Obesity/overweight
• Xultophy (liraglutide + insulin degludec) Type 2 diabetes
• Zepbound (tirzepatide) Obesity/overweight

This article originally appeared on Formulary Watch.

Reference

1. 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. News release. FDA. January 11, 2024. Accessed January 11, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type