July 11, 2023 – The European Medicines Agency is investigating Ozempic and one other weight-loss drug over concerns the drugs may increase the danger 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 analogous drug called Saxenda, in accordance with 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 status of other simpler weight reduction drugs. The drugmaker issued an announcement to several media outlets, saying that safety is the corporate's top priority and all reports of hostile 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 comprises the identical energetic 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 energetic ingredient in Ozempic and Wegovy, in accordance with a Reuters evaluation. For the drug liraglutide, which is the energetic 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 observe drug safety even after a drug is approved within the United States.