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The EU's drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Ozempic and Wegovy to further investigate suicidal thoughts in some patients taking them.
(Reuters) -The EU's drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Novo Nordisk's popular therapies Ozempic and Wegovy to further investigate suicidal thoughts in some patients taking them. "While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified," the European Medicines Agency (EMA) said in a statement on Friday, making it the first major global regulator to provided an update on such reviews. EMA's Pharmacovigilance Risk Assessment Commi...
A panel of external advisors to the U.S. Food and Drug Administration voted against Intarcia Therapeutics' diabetes treatment implant on Thursday, citing risks from potential side-effects. The committee unanimously held that the benefits of the drug-device combination for the treatment of type 2 diabetes did not outweigh its risks, pointing to the need for additional safety data. The decision comes on the back of two previous rejections by the health regulator owing to the drug's potential acute kidney injury (AKI) and cardiovascular risks.
The probe into potentially life-threatening side effects comes as the drugs skyrocket in popularity in the U.S. and draw heightened investor interest.
