SUMMARY
- The European Medicines Agency launches an investigation into obesity and diabetes drugs following reports of users experiencing suicidal and self-destructive thoughts.
- The investigation comes after the Icelandic Medicines Agency raised a signal due to three concerning case reports related to medications containing semaglutide or liraglutide.
- Danish pharmaceutical company Novo Nordisk, the manufacturer of the drugs under review.
The European Medicines Agency (EMA) announced this week that it's investigating several drugs utilized in treating obesity and diabetes. This comes after reports emerged of some users experiencing suicidal or self-destructive thoughts.
In an official communication, the EMA disclosed that its safety panel, also known as PRAC, is "probing the probability of suicide ideation and self-harm amongst individuals using semaglutide or liraglutide-based medications for shedding pounds."
This scrutiny follows an alert issued by the Icelandic Medicines Agency due to three concerning case reports. A "signal" in this context indicates a fresh or recognized adverse event potentially caused by a medication that requires further study.
Detailed case reports from the EMA revealed two incidents of suicidal thoughts - one after using Saxenda and another post-Ozempic use. Another incident involved self-harm ideation following Saxenda administration. The semaglutide-inclusive drug Wegovy and liraglutide-infused Saxenda are authorized for weight reduction in conjunction with diet and physical activity.
The active ingredient in Ozempic, a medication used to manage type 2 diabetes, is semaglutide. Both this drug and Saxenda are produced by Novo Nordisk, a Danish pharmaceutical company. Even as these developments surfaced, the firm's shares experienced a mild increase on Monday afternoon.
Suicidal behavior is not recognized as a side effect for these medications as per EU product information. The EMA, however, stated that PRAC might extend its review to other drugs from the same 'GLP-1 receptor agonist' class.
Novo Nordisk responded by emphasizing that patient safety remains its utmost priority and that they handle all adverse event reports linked to their products with grave seriousness.
For over a decade, GLP-1 receptor agonists, including Novo Nordisk products like semaglutide and liraglutide, have been used in type 2 diabetes treatment. These products have been on the market for over 10 years, and have been used in obesity treatment for 8 years.
The company maintains that safety data from large clinical trials and post-marketing surveillance haven't established a direct link between semaglutide or liraglutide and suicidal or self-harming thoughts. Novo Nordisk reassures that they are ceaselessly observing data from ongoing clinical trials and the real-world application of their products. The company collaborates closely with authorities to ensure patient safety and to provide adequate information to healthcare professionals. The company stated, “Novo Nordisk remains confident in the benefit-risk profile of the products and remains committed to ensuring patient safety.”
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