EMA’s Safety Committee Reviews Risk of Suicidal Thoughts with Weight Loss and Diabetes Drugs
The safety committee of the European Medicines Agency (EMA), known as the Prac, is currently examining data on the risk of suicidal thoughts and thoughts of self-harm associated with Glp-1 receptor agonist drugs. These medications are commonly used for weight loss and the treatment of type 2 diabetes. Specifically, the review includes drugs such as Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide).
The investigation was initiated by the Icelandic medicines agency following reports of suicidal thoughts and self-harm in individuals using liraglutide and semaglutide-based medicines. So far, authorities have collected and are analyzing approximately 150 reports of possible cases of self-harm and suicidal thoughts.
“The drugs liraglutide and semaglutide are widely used, with more than 20 million patient-years of exposure to date. It is still uncertain whether the reported cases are directly related to the drugs themselves or if they are due to the patients’ underlying conditions or other factors,” explains the EMA.
The review is currently ongoing as part of a reporting process. A signal, in this context, refers to information about a new adverse event that may be caused by a medicinal product or a new aspect of a known adverse event that requires further investigation. The presence of a signal does not necessarily mean that a medicine caused the adverse event in question.
Initially focused on Ozempic, Saxenda, and Wegovy, the review commenced on July 3 and has now been expanded to include other Glp-1 receptor agonists. The conclusion of the review is expected in November 2023.
This investigation highlights the importance of closely monitoring the safety of medications and promptly investigating any potential risks associated with their use. Patients are advised to consult their healthcare providers if they have any concerns or questions regarding the use of these drugs. The EMA will continue to update the public on any new findings related to the ongoing review.