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FDA warns Novo Nordisk over unreported potential Ozempic side effects

Home - CBSNews.com·@Cbsnews·2 months ago
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Novo Nordisk, the pharmaceutical company behind Ozempic, has received a warning letter from the U.S. Food and Drug Administration over issues with its procedures for reporting potential side effects of the flagship diabetes drug, which is also prescribed for weight loss. In the letter, dated March 5, the FDA cited three deaths among patients receiving semaglutide, the generic name for the medication in Novo Nordisk's Ozempic and Wegovy, which were allegedly not reported properly to the agency. Those deaths included one suicide, according to the FDA. Another instance involved a patient that reported suicidal ideations while taking semaglutide.The FDA did not speculate as to whether the deaths or other side effects were necessarily linked to the medication. Its letter focused on the fact that Novo Nordisk apparently violated its protocols for reporting adverse symptoms that could potentially be tied to the drug.…

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