The European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonists.
The drugs under review include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), used for weight loss and for treating type 2 diabetes.
The review was triggered by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide medicines.
So far, authorities have retrieved and are analysing about 150 reports of possible cases of self-injury and suicidal thoughts.
A new adverse event
Liraglutide and semaglutide are widely used, with an exposure of over 20 million patient-years to date. It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors.
The review is being carried out in the context of a signal procedure. A signal is information on a new adverse event that is potentially caused by a medicine or a new aspect of a known adverse event that warrants further investigation. The presence of a signal does not necessarily mean that a medicine caused the adverse event in question.
Saxenda and Wegovy are authorised for weight management, together with diet and physical activity in people who are obese or overweight in the presence of at least one weight-related health problem.
Ozempic is authorised for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise but has been used off-label for weight loss.
Suicidal behaviour is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonists. The review is expected to conclude in November 2023.