Meeting Highlights from the Pharmacovigilance Risk Assessment Committee 8-11 April 2024

19. April 2024 – The Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed evidence regarding the association between Glucagon-Like Peptide-1 receptor agonists (GLP-1) - dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide - and suicidal/self-injurious thoughts/actions. The review, due to case reports, found no causal link between these medications and such thoughts/actions. Studies, including a large database analysis and one by the European Medicines Agency (EMA), supported this conclusion. Consequently, no updates to product information were deemed necessary. Marketing authorization holders will continue monitoring and reporting on this matter.

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