The European Medicines Agency (EMA) found no evidence to support a causal link between GLP-1 receptor agonists and suicidal thoughts, a committee said on Friday following a 9-month review.

An investigation was launched in July 2023 over reports of suicidal ideation and self-harm thoughts and actions not previously reported in any clinical trials. The investigation was extended again last November when the committee requested more postmarketing data from the drugmakers.

But after reviewing the totality of evidence from non-clinical studies, clinical trials, and post-marketing surveillance data, the committee said that an update to the product information is not warranted.

"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)," the committee noted.

This more definitive conclusion comes on the heels of the FDA's preliminary evaluation of the issue, which was released in January.

At that time, the FDA said that while it "cannot definitively rule out that a small risk may exist," its preliminary evaluation did not suggest a causal link. "We will communicate our final conclusions and recommendations after we complete our review or have more information to share," the agency wrote in its safety communication.

The EMA's conclusion was based on the recent Nature Medicine study of 240,618 patients who had overweight or obesity taking semaglutide (Ozempic, Rybelsus, Wegovy). Interestingly, there was a significantly lower risk of suicidal ideation among these patients compared with those on non-GLP-1 anti-obesity medications (0.11% vs 0.43%; HR 0.27, 95% CI 0.20-0.36).

This study also looked at 1,572,885 patients with type 2 diabetes on semaglutide, who had a significantly lower risk of suicidal ideation compared with patients taking other anti-diabetes medications (0.13% vs 0.36%; HR 0.36, 95% CI 0.25-0.53).

In addition, the review included an analysis that the EMA conducted independently that compared type 2 diabetes patients on a GLP-1 receptor agonist with those on an SGLT2 inhibitor, but no results were reported.

The EMA's announcement was exclusive to agents in the GLP-1 receptor agonist class currently approved in Europe -- semaglutide, liraglutide (Victoza, Saxenda), liraglutide/insulin degludec (Xultophy), dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), lixisenatide (Adlyxin), and lixisenatide/insulin glargine (Soliqua). It didn't include FDA-approved tirzepatide (Mounjaro, Zepbound), a dual GIP/GLP-1 receptor agonist. These agents have indications for the treatment of type 2 diabetes, obesity, or both.

If you or someone you know is considering suicide, call or text 988 or go to the 988 Suicide and Crisis Lifeline website.

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, shes worked at the company since 2015.

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No Link Between GLP-1 Drugs and Suicide, Says European Regulator - Medpage Today