The European Union's drug regulator has asked drugmakers including Novo Nordisk A/S and Eli Lilly and Company for more information as it investigates 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 receiving reports of suicidal thoughts and self-harm from people taking anti-obesity drugs. The review focused on so-called GLP-1 treatments, which include Novo's Wegovy weight loss shot and the company's diabetes drug Ozempic. These drugs are among the best-selling products in the pharmaceutical industry.
The EMA's safety committee said in a statement on Friday that it had considered all clinical trial evidence and published literature on the subject, adding: “At this stage we cannot draw any conclusions about causation, but this is a question that still needs to be clarified. There are several,” he added. revealed. ”
The committee agreed on a further list of questions for these drug manufacturers to address and said it would discuss the topic again at its April meeting.
Although GLP-1 drugs have been used for weight loss relatively recently, they have been used as a treatment for diabetes for more than 15 years. The EMA investigation also includes dulaglutide, the active ingredient in Lilly's diabetes drug Trulicity, and AstraZeneca's diabetes drug Byetta.
“Patient safety is Lilly's top priority,” a company spokesperson told Bloomberg on Friday. “We continue to respond to regulatory reviews regarding safety signals related to dulaglutide as part of our regular regulatory review process.”
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