Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023 with new safety information for GLP-1 receptor agonists.

The PRAC has reviewed the available evidence from clinical trials, post-marketing surveillance and the published literature on reported cases of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists.

While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified. The committee has agreed further lists of questions to be addressed by the respective marketing authorisation holders for these medicines, namely Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Xultophy, Byetta, Bydureon, Lyxumia, Suliqua and Trulicity.

The PRAC will rediscuss this topic at its meeting in April 2024. EMA will communicate further when new information is available.