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Novo Nordisk has been having a rough year, and this latest development isn\u2019t helping.<\/p>\n
Novo Nordisk got a warning letter from the US Food and Drug Administration for not reporting all suspected side effects in patients who took its blockbuster Ozempic. https:\/\/t.co\/lKuoummBrc<\/a><\/p>\n \u2014 Bloomberg (@business) March 10, 2026<\/a><\/p>\n The FDA issued a warning letter to the Danish drugmaker on March 5, citing \u201cserious violations\u201d related to how it reported \u2014 or failed to report \u2014 potential side effects linked to semaglutide, the active ingredient in Ozempic and Wegovy.<\/p>\n The violations were discovered during an inspection of a Novo Nordisk facility in New Jersey last year.<\/p>\n Three deaths were flagged in the letter, including two deaths and one suicide. The FDA said Novo failed to investigate or report the suicide case within the required time frame.<\/p>\n The FDA was clear that it is not saying the medications caused these deaths. The concern is about the reporting process, not a direct causal link.<\/p>\n \u201cFDA relies on the complete, accurate, and timely submission of ADEs to monitor a product\u2019s safety profile,\u201d the agency wrote, referring to adverse drug events.<\/p>\n Novo Nordisk<\/a> has been given two weeks to notify the FDA of the steps it will take to prevent future violations.<\/p>\n The company responded publicly, saying it has been working \u201cdiligently\u201d to address the FDA\u2019s concerns. It confirmed it had sent the agency an initial response and seven follow-up updates.<\/p>\n Novo also said the cited cases \u201chave been evaluated\u201d and have since been \u201cprocessed and reported appropriately.\u201d The company did not deny that it had previously failed to report them.<\/p>\n A Pattern of Regulatory Issues<\/p>\n This is not the first time Novo has been in the FDA\u2019s crosshairs recently. In December, a separate warning letter was sent to its Bloomington, Indiana facility over violations of Good Manufacturing Practice regulations.<\/p>\n
Novo Nordisk A\/S, NVO
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