EMA: No Evidence of Link Between GLP-1 Receptor Agonists and Suicidal Thoughts

The available evidence does not support a greater risk of suicidal or self-injurious thoughts and actions among users of glucagon-like peptide-1 (GLP-1) receptor agonists, according to a safety committee of the European Medicines Agency (EMA).

This conclusion—coming from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which met this week—is consistent with a review from the US Food and Drug Administration.

That’s reassuring considering the growing popularity of the GLP-1 receptor agonists, which are used for the treatment of type 2 diabetes and for weight loss in individuals with overweight or obesity. Data from the SELECT trial of semaglutide (Wegovy; Novo Nordisk) also show that there are cardiovascular benefits in high-risk patients.

Reports started emerging about a possible link between the medications and suicidal thoughts or actions last year, with the EMA saying that it would start looking into the issue in July 2023. Later in the year, the PRAC requested additional data from the drug manufacturers. The committee also analyzed the results of a study released earlier this year—based on electronic health records, it showed no causal association between GLP-1 receptor agonists and suicidal thoughts.

The EMA conducted a study of its own, also based on electronic health records, that came to a similar conclusion.

“After reviewing the available evidence from nonclinical studies, clinical trials, postmarketing surveillance data and the available studies, the PRAC considers that no update to the product information is warranted,” the committee said Friday. “The marketing authorization holders for these medicines will continue to monitor these events closely, including any new publications, as part of their pharmacovigilance  activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs).”