The European Union’s pharmaceutical regulator has asked pharmaceutical companies, including Novo Nordisk A/S and Elie Lilly & Co. for more information as it examines the potential risk of suicidal thoughts associated with a new class of weight-loss drugs.
The European Medicines Agency began investigating the issue in July after reports of suicidal thoughts and self-harm among people taking anti-obesity drugs. The review focuses on so-called GLP-1 treatments, a class that includes Novo’s weight-loss vaccine Wegovy as well as its diabetes drug Ozempic. These drugs are among the most sold in the pharmaceutical sector.
In a statement released on Friday, the EMA safety committee said it had reviewed all clinical trial evidence and published literature on the subject, adding: “Although at this stage no conclusions can be drawn on a causal association, several questions still need to be clarified.”
The committee agreed on further lists of questions for manufacturers of these drugs to answer and said it would discuss the topic again at its April meeting.
Although their use for weight loss is relatively new, GLP-1 drugs have a history of more than 15 years in the treatment of diabetes. The EMA investigation also focuses on dulaglutide, the active ingredient in Lilly’s diabetes drug Trulicity, and AstraZeneca Plc’s diabetes drug Byetta.
“Patient safety is Lilly’s top priority,” a company spokesperson told Bloomberg on Friday. “We will continue to respond to regulatory reviews regarding safety signals related to dulaglutide as part of our routine regulatory review processes. »
