Slimming drugs that could lead to suicidal thoughts are currently under review by the European Medicines Agency (EMA) to investigate a possible correlation between the use of these medications and an increased risk of self-harm and suicidal tendencies. The EMA has received approximately 150 reports of potential cases of self-harm and suicidal thoughts in individuals using medicines containing liraglutide and semaglutide, which are commonly used for weight loss and the treatment of type 2 diabetes.
The EMA has initiated an official review of the drugs under investigation, including Ozempic* (semaglutide), Saxenda* (liraglutide), and Wegovy* (semaglutide). The review, which began in July, has been extended to include other Glp-1 receptor agonists. The EMA expects the review to be completed by November 2023.
The initial alarms regarding the potential side effects of these drugs were raised by the Icelandic drug agency after reports of suicidal thoughts and self-harm in individuals using liraglutide and semaglutide. These drugs have been widely used, with an exposure of over 20 million patients each year.
The ongoing review is part of a signaling procedure, where new adverse events potentially caused by a drug are investigated further. The EMA clarifies that the presence of a signal does not necessarily mean that a medicinal product caused the adverse event, as it could be attributed to underlying conditions or other factors. It is yet to be determined whether the reported cases are directly linked to the drugs themselves.
Saxenda and Wegovy are authorized for weight management in obese or overweight individuals with weight-related health problems, while Ozempic is licensed for the treatment of adults with type 2 diabetes. However, Ozempic has also been used off-label for weight loss. Currently, suicidal behavior is not listed as a known side effect of any Glp-1 receptor agonist in the EU product information.
The EMA’s investigation aims to provide a comprehensive understanding of the potential risks associated with these medications and ensure the safety of patients using them. The outcome of the review will inform regulatory decisions and any necessary updates to product information and warnings.