July 11, 2023 – The European Medicines Agency is investigating Ozempic and one other weight-loss drug over concerns the drugs may increase the chance of suicide.
The agency Safety Committeewhich conducts safety studies on approved drugs, met last week. The investigation got here after an Icelandic health authority reported three cases of suicidal thoughts or self-harm in people taking Ozempic or an identical drug called Saxenda, in response to the news agency Reuters.
Both drugs are manufactured by Danish pharmaceutical company Novo Nordisk. Ozempic is approved within the US to treat diabetes, but is best known for its effects in weight reduction. Saxenda is FDA-approved for weight reduction, but doesn't have the popularity of other simpler weight reduction drugs. The drugmaker issued a press release to several media outlets, saying that safety is the corporate's top priority and all reports of antagonistic events are taken very seriously.
According to Reuters, the prescribing information for Saxenda and Ozempic within the European Union doesn't list suicidal thoughts as a side effect. US prescribing instructions for the weight-loss drug Wayswhich incorporates the identical lively ingredient as Ozempic, advise monitoring for suicidal thoughts or behavior. The US prescribing instructions for Saxenda This includes monitoring for suicidal thoughts and depression.
A FDA database lists 60 reports of suicidal thoughts or ideation since 2018 in people taking the drug semaglutide, which is the lively ingredient in Ozempic and Wegovy, in response to a Reuters evaluation. For the drug liraglutide, which is the lively ingredient in Saxenda, the news agency found 70 reports since 2010.
The FDA states that reports don't establish causality and that the agency continues to watch drug safety even after a drug is approved within the United States.