The Food and Drug Administration issued a warning letter to Novo Nordisk \u2014 the maker of Ozempic and Wegovy \u2014 for failing to report potential side effects in patients who took its blockbuster medications.<\/p>\n
In a letter dated March 5<\/a>, the FDA criticized Novo Nordisk for \u201cserious violations\u201d related to the reporting of possible side effects linked to semaglutide, the active ingredient in Ozempic and Wegovy.<\/p>\n The FDA cited three deaths among patients who took the medications, including one who died by suicide, saying the company did not report them within the agency\u2019s required time frame. It said Novo Nordisk failed to investigate or report the suicide.<\/p>\n The FDA did not say the medications caused the deaths or other side effects.<\/p>\n \u201cFDA relies on the complete, accurate, and timely submission of ADEs to monitor a product\u2019s safety profile and uphold FDA\u2019s mission to protect and promote public health,\u201d the FDA wrote, referring to \u201cadverse drug events.\u201d<\/p>\n It said findings were based on an inspection of a Novo Nordisk facility in New Jersey last year.<\/p>\n The FDA said it is giving Novo Nordisk two weeks to notify it of the actions it will take to prevent future violations.<\/p>\n