The PRAC, the safety committee of the European Medicines Agency (EMA), is reviewing the data on the risk of suicidal thoughts and thoughts of self-harm linked to drugs known as GLP-1 receptor agonists, the already popular Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide). These drugs that have skyrocketed their sales in recent months are used to lose weight and to treat type 2 diabetes.
The review was initiated by the Icelandic medicines agency after receiving several reports that suicidal thoughts and self harm in people using medicines such as liraglutide and semaglutide. So far, authorities have recovered and are analyzing around 150 reports of possible cases of self-harm and suicidal thoughts.
The drugs liraglutide and semaglutide are widely used, with exposure to date of more than 20 million patient-years. It is not yet clear whether the reported cases are related to the drugs themselves or to the patients’ underlying conditions or other factors.
The review is carried out in the context of a designated procedure. A signal is information about a new adverse event potentially caused by a drug or a new aspect of a known adverse event that warrants further investigation. The presence of a signal does not necessarily mean that a drug caused the adverse event in question.
Suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonist
Saxenda y Wegovy are licensed for weight control, along with diet and physical activity, in obese or overweight individuals in the presence of at least one weight-related health problem. Ozempic is licensed for the treatment of adults with inadequately controlled type 2 diabetes as an adjunct to diet and exercise, but has been used off-label for weight loss. Suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonist.
The Ozempic, Saxenda, and Wegovy review began on July 3, 2023, and has now been expanded to include other GLP-1 receptor agonists. This review is expected to be completed in November 2023.
Safety Sign Information
Information on the initiation of safety sign reviews is available in the published agendas of the PRAC monthly plenary meetings, and the results of the reviews are published on a dedicated web page. The results of certain signal reviews will also be included in the PRAC monthly highlights. In certain cases, for example when there is strong public interest, the EMA may issue a news announcement during a signal review.
As with all medicines, patients and healthcare professionals are advised to use GLP-1 receptor agonists in accordance with the approved product information. Patients and healthcare professionals should also inform the authorities about possible side effects. Information on how to report suspected side effects is available in the package leaflets and on the websites of the national medicines authorities.