Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024.

GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions

After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide – and suicidal and self-injurious thoughts and actions.

The marketing authorisation holders for these medicines will continue to monitor these events closely.

New safety information for healthcare professionals: advice to CHMP on new Rybelsus tablets (oral semaglutide)

The PRAC agreed on the content of a Direct Healthcare Professional Communication aiming at informing healthcare professionals on the differences between current and newly proposed formulations of Rybelsus (oral semaglutide, a medicine used in type 2 diabetes) to prevent a risk of medication errors.