The European Medicines Agency (EMA) is currently reviewing weight-loss injections after receiving reports suggesting a potential link to suicidal thoughts and self-harm among users. The EMA was alerted to these concerns by Iceland, a member state, after three cases were reported.
The review will specifically focus on medications such as Wegovy, Saxenda, and similar drugs, which are designed to reduce a person’s appetite. While the product leaflets already include suicidal thoughts as a possible side effect, suicidal behavior is not specifically listed for these prescription drugs.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will conduct the review and will also consider whether other medications in the same broader category, known as glucagon-like peptide-1 (GLP-1) receptor agonists, should be assessed as well.
The initial assessment will analyze the risks associated with medications containing semaglutide or liraglutide. The review was initiated following a signal procedure raised by the Icelandic Medicines Agency based on three case reports.
A signal procedure refers to the process of investigating new or known adverse events potentially caused by a medicine that requires further investigation. The EMA will conduct a thorough analysis to determine the potential risks and take appropriate actions based on the findings.