The U.S. Food and Drug Administration (FDA) has been investigating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (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. The FDA's preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.
Over the last several months, the FDA has conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS). The information provided was often limited and these events can be influenced by other potential factors, leading the FDA to determine that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs.
Similarly, the FDA's 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, due to the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, the FDA cannot definitively rule out that a small risk may exist. Therefore, the FDA is continuing to investigate 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, a large data network that contains health insurance claims and patient health records that can be used to investigate safety questions about FDA-regulated products.
The FDA will communicate its final conclusions and recommendations after it completes its review or has more information to share. In the meantime, patients should not stop taking GLP-1 RAs without first consulting their health care professional, as stopping these medicines may worsen their condition. Patients are advised to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior to their health care professional.
The list of GLP-1 RAs (glucagon-like peptide-1 receptor agonists) approved by the FDA includes:
- Byetta (exenatide) - Approved in 2005 for Type 2 diabetes
- Victoza (liraglutide) - Approved in 2010 for Type 2 diabetes
- Trulicity (dulaglutide) - Approved in 2014 for Type 2 diabetes
- Saxenda (liraglutide) - Approved in 2014 for Obesity/overweight
- Adlyxin (lixisenatide) - Approved in 2016 for Type 2 diabetes
- Xultophy (liraglutide + insulin degludec) - Approved in 2016 for Type 2 diabetes
- Soliqua (lixisenatide + insulin glargine) - Approved in 2016 for Type 2 diabetes
- Bydureon BCise (exenatide) - Approved in 2017 for Type 2 diabetes
- Ozempic (semaglutide) - Approved in 2017 for Type 2 diabetes
- Rybelsus (semaglutide) - Approved in 2019 for Type 2 diabetes
- Wegovy (semaglutide) - Approved in 2021 for Obesity/overweight
- Mounjaro (tirzepatide) - Approved in 2022 for Type 2 diabetes
- Zepbound - Approved in 2023 for Obesity/overweight
