WASHINGTON \u2014\u00a0The Food and Drug Administration raised concerns about \u201cserious violations\u201d of its reporting requirements regarding potential side effects of medications by the major global health company behind the popular weight management drugs known as Ozempic and Wegovy.<\/p>\n
What You Need To Know<\/p>\n
The Food and Drug Administration raised concerns about \u201cserious violations\u201d of its reporting requirements regarding potential side effects of medications by the major global health company behind the popular weight management drugs known as Ozempic and Wegovy
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In a\u00a0letter to Novo Nordisk this month, the FDA cited several specific instances in which it said the health company failed to fully comply with reporting requirements and follow-up policies
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Three of the cases referenced involved death of patients who were using semaglutide\u00a0\u2014 the active ingredient in Ozempic and Wegovy -\u2014 one of which was a suicide, according to the FDA; it did not suggest adverse effects or deaths in patients taking Novo Nordisk products were directly linked to or caused by the drugs
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In a statement, Novo Nordisk said it is responding to the FDA’s note and has been \u201cworking to resolve\u201d concerns presented by the agency, adding that the agency’s letter\u00a0\u201cdoes not make any conclusions about the quality or safety of our medicines”<\/p>\n
In a letter to Novo Nordisk this month<\/a>, the FDA cited several specific instances in which it said the health company failed to fully comply with reporting requirements and follow-up policies regarding patients who took semaglutide, the active ingredient in Ozempic and Wegovy, as well as liraglutide, also used in some GLP-1 medications. Three of the cases referenced involved the deaths of patients who were using semaglutide, one of which was a suicide, according to the FDA.\u00a0<\/p>\n The letter also pointed to a case in which a person using liraglutide suffered a stroke and became disabled. While the FDA noted that the person said the stroke was not linked to the ingredient, it also stressed that its rules require any \u201cadverse event associated with the use of a drug in humans, whether or not considered drug-related\u201d to be reported. It also did not suggest the other adverse effects or deaths in patients taking Novo Nordisk products were directly linked to or caused by the drugs.<\/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 in the letter regarding what it calls adverse events. \u201cReporting ADEs to FDA within the required time frames is necessary for the ongoing monitoring of drug safety profiles.\u201d<\/p>\n In the letter, the FDA noted the warning stems from an inspection conducted at one of Novo Nordisk\u2019s firms early last year in which \u201cobjectionable conditions\u201d were observed. The federal health agency gave Novo Nordisk 15 days to issue a written response outlining the actions it has taken to \u201cprevent similar violations in the future.\u201d The FDA notes failure to adequately address the matter can lead to regulatory action.\u00a0<\/p>\n