WASHINGTON — The Food and Drug Administration raised concerns about “serious violations” 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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The Food and Drug Administration raised concerns about “serious violations” 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

In a letter 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

Three of the cases referenced involved death of patients who were using semaglutide — the active ingredient in Ozempic and Wegovy -— 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

In a statement, Novo Nordisk said it is responding to the FDA’s note and has been “working to resolve” concerns presented by the agency, adding that the agency’s letter “does not make any conclusions about the quality or safety of our medicines”

In a letter 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 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. 

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 “adverse event associated with the use of a drug in humans, whether or not considered drug-related” 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.

“FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health,” the FDA wrote in the letter regarding what it calls adverse events. “Reporting ADEs to FDA within the required time frames is necessary for the ongoing monitoring of drug safety profiles.”

In the letter, the FDA noted the warning stems from an inspection conducted at one of Novo Nordisk’s firms early last year in which “objectionable conditions” were observed. The federal health agency gave Novo Nordisk 15 days to issue a written response outlining the actions it has taken to “prevent similar violations in the future.” The FDA notes failure to adequately address the matter can lead to regulatory action. 

In a statement this week, Novo Nordisk acknowledged it received the letter and noted that the inspection referenced by the FDA took place at its site in Plainsboro, New Jersey. In its response, the company went on to say it is responding to the note and has been “working to resolve” concerns presented by the FDA since the inspection.

“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk U.S., said in the statement.

The company also pointed out that the FDA in its letter recognized Novo Nordisk’s efforts to better comply with requirements over the last year and noted that the agency “does not make any conclusions about the quality or safety of our medicines.”

Weight loss treatments like Wegovy, known more formally as GLP-1 drugs, have become massively popular and increasingly sought after in recent years. President Donald Trump last year announced an agreement with some of the companies behind them, including Novo Nordisk, to seek to lower the cost of such drugs.