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# EMA Committee Dismisses GLP-1 Suicidality Risk
- URL: https://www.fdaweb.com/ema-committee-dismisses-glp-1-suicidality-risk/
- Published: 2024-04-12T12:00:00.000Z
- Updated: 2026-09-14T14:28:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156768

As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 4/12 concluded that available evidence does not support a causal association. The drugs are used to treat Type 2 diabetes and obesity-related weight management under certain conditions in adults who are obese or overweight.

[Earlier this year](https://www.fdaweb.com/no-clarity-yet-on-ozempic-suicide-risk-fda/), an FDA drug safety [update](https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type?utm%5Fmedium=email&utm%5Fsource=govdelivery) said its preliminary evaluation did not suggest a causal link, but such a link also could not be definitively ruled out, given the small number of occurrences recorded in clinical trials.

The EMA committee says that part of its [review](https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024?ref=fdaweb.com) analyzed the results of a recent study, based on a large database of electronic health records, which investigated the incidence of suicidal thoughts in patients treated with semaglutide (Ozempic and Wegovy) or other non-GLP-1 receptor agonist medicines for diabetes or weight loss. The study found no causal association between the use of semaglutide and suicidal thoughts, it says. Another study was conducted by EMA, based on electronic health records, which also did not support a causal association between the use of GLP-1 receptor agonists and the risk.

"After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC considers that no update to the product information is warranted,” EMA says.