The Food and Drug Administration sent a warning letter to the makers of Ozempic and Wegovy for not reporting potential side effects of the drugs.<\/p>\n
The agency told Novo Nordisk<\/a> it had \u201cserious violations\u201d connected to semaglutide, the active ingredient in the medications, NBC News<\/a> reported. <\/p>\n The FDA said there were three deaths of patients who were using the GLP-1 medications. One died by suicide, The Hill <\/a>reported. The FDA did not say that the medication caused the deaths or side effects.<\/p>\n The federal agency said the company did not tell the FDA about the deaths in the required time frame and that Novo Nordisk did not investigate or report the suicide. <\/p>\n The FDA had recently determined that there was no connection between GLP-1s and suicide, CBS News<\/a> reported. It had requested in January to remove warnings about suicidal behavior or ideation from the treatments.<\/p>\n Novo Nordisk had 15 days to report adverse reactions to the medications, The Hill<\/a> reported.<\/p>\n One case involved someone who had a stroke while taking GLP-1 liraglutide.<\/p>\n \u201cThe consumer reported the stroke was not related to liraglutide, therefore you rejected this case. As a result, you failed to report serious and unexpected [adverse drug events] to FDA within 15 calendar days as required by [Postmarketing Adverse Drug Experience] regulations,\u201d the FDA told Novo Nordisk, according to The Hill<\/a>.<\/p>\n The FDA gave Novo Nordisk two weeks to tell them of the steps the company will take to prevent violations. <\/p>\n