European Medicines Agency Launches Review on Slimming Drugs and Potential Link to Suicide Risk
July 15, 2023
The European Medicines Agency (EMA) has announced that it will be conducting a review process on certain slimming drugs following reports of a potential link to an increased risk of suicide. The decision to initiate the review came after the Icelandic regulatory body reported about 150 cases related to the use of liraglutide and semaglutide-based medicines, which are commonly used for weight loss and the treatment of type 2 diabetes.
In an official note, the EMA cited the review initiated by the Pharmacovigilance Committee (Prac) on these products. Various international media outlets, including the BBC, have also confirmed the start of the review.
The drugs affected by the review are Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide). The safety review began on July 3 and has been expanded to include other Glp-1 receptor agonists. The EMA forecasts that the review will conclude in November 2023. The Prac committee will investigate the possible connection between these drugs and suicidal thoughts and self-harm.
These products have been widely used, with an exposure of more than 20 million patient-years to date. Saxenda and Wegovy are authorized for weight management in obese or overweight individuals with weight-related health problems. Ozempic, on the other hand, is authorized for the treatment of adults with insufficiently controlled type 2 diabetes but has been used off-label for weight loss.
It is important to note that suicidal behavior is not currently listed as a side effect in the product information for any Glp-1 receptor agonist in the EU.
In recent months, these drugs have gained media attention, leading to an increase in requests for them. Ozempic, in particular, has been under scrutiny due to problems arising from its improper use by non-diabetic individuals seeking weight loss. Novo Nordisk, the company that manufactures these drugs, emphasized the importance of patient safety and confirmed its collaboration with the EMA. They stated that they continuously monitor data from ongoing clinical trials and real-world use of their products and work closely with authorities to ensure patient safety and provide adequate information to healthcare professionals.
The EMA’s review aims to provide a comprehensive assessment of the potential risks associated with these slimming drugs and will be crucial in guiding future regulatory decisions regarding their usage.
In other news, the United States Food and Drug Administration (FDA) has recently given the green light to a new drug for Alzheimer’s disease. This development highlights the ongoing efforts to address various health concerns and improve patient care worldwide.
– European Medicines Agency (EMA)