The European Union’s drug regulator concluded, after a nine-month investigation, that there is no evidence linking a group of diabetes and weight-loss drugs, including Novo Nordisk’s widely popular Wegovy, to suicidal thoughts. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee, responsible for monitoring drug side effects, stated that no updates to the product information are deemed necessary based on the review of available evidence.
This finding follows the EMA’s decision in December to extend its examination of GLP-1 receptor agonists, a class of weight-loss and diabetes drugs, to gather additional data from manufacturers for further investigation into the matter.
The evaluation commenced in July following concerns raised by Iceland’s health regulator regarding three cases of patients expressing thoughts of suicide or self-harm after using Novo’s medications. The review focused on drugs containing either semaglutide or liraglutide, both of which are GLP-1 targeting compounds.
Liraglutide serves as the active ingredient in Novo’s weight-loss treatment Saxenda, whereas semaglutide is the active ingredient in Wegovy and the top-selling diabetes treatment Ozempic.
The EMA also examined approximately 170 additional case reports concerning suspected adverse reactions recorded in the EU’s EudraVigilance database.
The initial assessment conducted by the US Food and Drug Administration in January found no connection between GLP-1 medications and suicidal thoughts or behaviors.
GLP-1 receptor agonists, initially designed to aid in blood sugar control for diabetic patients, include Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, which also work to slow digestion and decrease appetite.
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