EMA safety committee finds no causal link between GLP-1 drugs and suicidal thoughts

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the available evidence does not support a causal association between GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) and suicidal or self-injurious thoughts and actions. The review weighed non-clinical studies, clinical trials, post-marketing reports and two large electronic health record studies. No update to EU product information was required.

Sources

  1. 01Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024(opens the source in a new tab) European Medicines Agency
  2. 02EMA finds no link between GLP-1 receptor agonists and suicidal thoughts(opens the source in a new tab) The Pharmaceutical Journal

Peptides involved

  1. ApprovedSemaglutideGLP-1 receptor agonist31
  2. ApprovedLiraglutideGLP-1 receptor agonist31
  3. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31
  4. ApprovedExenatideGLP-1 receptor agonist39