EMA finds no link between GLP-1 drugs and suicidal thoughts, self-harm

Published: Apr 12, 2024

By Tristan Manalac

BioSpace

The European Medicines Agency announced on Friday that it has found no causal association between GLP-1 receptor agonists—a popular class of weight-loss treatments that include Novo Nordisk’s Wegovy (semaglutide)—and the risks of suicidal thoughts and actions.

The agency arrived at this conclusion following a review by its Pharmacovigilance Risk Assessment Committee (PRAC), which looked at several cases of suicidal thoughts and self-harm among patients taking semaglutide and liraglutide, which is also owned by Novo and is sold under the brand name Saxenda.

In addition to semaglutide, which is also marketed as Ozempic for type 2 diabetes, the PRAC looked at other GLP-1 medicines including Eli Lilly’s Trulicity (dulaglutide) and AstraZeneca’s Byetta (exenatide).

In its review, the committee also evaluated data from a recent study, published in January 2024 in Nature Medicine, which used electronic health record data from over 240,000 overweight or obese patients to establish that GLP-1 medications do not aggravate suicidal ideation. Instead, the study found that GLP-1 analogs were associated with a significantly lower likelihood of suicidal thoughts.

This finding was consistent with a separate analysis using electronic records of nearly 1.6 million type 2 diabetes patients.

The European Medicines Agency (EMA) also conducted its own study to look at the potential link between suicidal thoughts and self-harm with the use of GLP-1 treatments. Their data supported no causal link, according to the EMA’s Friday announcement.

With this conclusion, the PRAC has said that it will require no update on the product information of GLP-1 products. Still, companies holding marketing authorizations should “continue to monitor these events closely … as part of their pharmacovigilance activities.”

The EMA first looked into the suicide risks of GLP-1 medications in July 2023, spurred by the Icelandic Medicines Agency which flagged several reports of suicidal thoughts and self-harm in people taking Saxenda and Ozempic.

In December 2023, after a preliminary review, the PRAC announced that it could not draw a definitive conclusion about a causal link. Pointing to “several issues that still need to be clarified,” the committee asked for “further clarifications” from drugmakers regarding their GLP-1 products. Earlier this week, the EMA announced that the PRAC would convene to continue its review.

The FDA in January 2024 also initiated an investigation into the suicidal ideation and self-harm risks of GLP-1 analogs, but a week later in a preliminary review found no evidence to support such an association.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at [email protected] or [email protected].

Source: BioSpace