The European Medicines Agency (EMA) has launched a thorough review of Novo Nordisk’s popular diabetes and obesity drugs, Ozempic (semaglutide) and Saxenda (liraglutide), in response to concerning reports of suicidal thoughts and self-harm among users in Iceland. The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA is conducting this regulatory examination to determine whether there is a causal link between the use of these blockbuster medications and the reported adverse events. Additionally, the PRAC has expanded the review to include another semaglutide drug from Novo Nordisk’s product line, Wegovy.
The GLP-1 treatments provided by Novo Nordisk have experienced a recent surge in popularity due to their ability to facilitate weight loss. Acknowledging this trend, the EMA is considering the possibility of extending the review to include all drugs within the widely-used GLP-1 class, which would involve assessing the emerging drug Mounjaro (tirzepatide) from Eli Lilly.
Of significant concern is the explicit connection between semaglutide and the potential manifestation of suicidal behavior, as indicated in the product label’s warning against its use in individuals with a history of suicide attempts or active suicidal ideation. Novo Nordisk expressed confidence in the overall benefit-risk profile of its products, citing the extensive history of GLP-1 receptor agonists being employed for the treatment of type 2 diabetes for over 15 years, as well as their usage in combating obesity for the past eight years. The company emphasized that the safety data collected from large-scale clinical trials and post-marketing surveillance have not established a definitive causal association between semaglutide or liraglutide and the occurrence of suicidal thoughts or acts of self-harm.
Another potential concern associated with GLP-1 treatments is the potential occurrence of thyroid cancer. In May, the EMA notified Novo Nordisk, along with other pharmaceutical companies manufacturing drugs within the GLP-1 class, including Lilly, AstraZeneca, and Sanofi, about the need to closely monitor signals indicating a possible link between these medications and thyroid cancer.
The reported cases from Iceland have brought to light distressing instances of suicidal thoughts in one user each of Ozempic and Saxenda. Furthermore, a separate case involving self-harm was reported by a Saxenda user. It is worth noting that in 2008, Sanofi’s weight-loss drug Acomplia, which functioned as a cannabinoid receptor CB1 antagonist, was withdrawn from the European market only two years after its approval due to incidents of depression and suicidal thoughts experienced by some patients. However, it is important to emphasize that GLP-1 treatments like Ozempic and Saxenda operate through a distinct mechanism of action.
The ongoing comprehensive review of Novo Nordisk’s GLP-1 drugs by the EMA aims to assess the potential risks associated with their use in a holistic manner. The findings of this evaluation will provide valuable insights into the overall safety profile of these medications and play a pivotal role in informing future regulatory decisions regarding their continued utilization.
