At least three Americans have been hospitalized after taking suspected counterfeit semaglutide drugs, including Novo Nordisk’s diabetes drug Ozempic, according to records released by the Food and Drug Administration.
Novo Nordisk’s other semaglutide drugs, Ozempic and Wigovy, areFor use in weight loss.
The hospitalizations are among 42 cases reported to police. FDA Adverse Event Reporting System What mentions the use of From all over the world. The agency last updated its database late last month to include reports compiled through the end of September.
Of the reports, 28 cases are classified as “serious,” including fatal cases.
Only some of them specifically mention Ozempic, including one of three people hospitalized in the United States. All of these were submitted to the FDA by Novo Nordisk, citing reports to the company by consumers or healthcare providers.
The record does not establish whether the counterfeit product was the cause of the complaint or incidental to the report.
An FDA spokesperson said the agency has “no new information to share regarding reports of adverse events” related to counterfeit versions of semaglutide.
“FDA investigates reports of suspected counterfeit drugs to determine the public health risk and appropriate regulatory response. FDA remains vigilant to protect the U.S. drug supply from these threats,” a spokesperson said. Jeremy Kahn said in an email.
The report comes as authorities around the world say they are battling a wave of such counterfeit medicines.
Late last month, the FDA’s UK counterpart, the Medicines and Health Products Regulatory Agency, Said The company had confiscated hundreds of “possibly counterfeit Ozempic pens since January 2023.”
The agency said it has also received reports of “a very small number of people being hospitalized” after using counterfeit products.
The FDA is also investigating a scheme to traffic counterfeit pens into U.S. pharmacies, industry groups said..
What is considered counterfeit?
Novo Nordisk announced in June that it was working with the FDA after a U.S. retailer sold Ozempic pens that turned out to be counterfeit.
The drug was packaged in a paper box with a fake label that could be mistaken for Novo Nordisk’s genuine Ozempic pen, but the drug company said it had a number of labels to help patients understand that they had purchased a counterfeit product. He said there is a clear difference.
“Working closely with the FDA, we have taken steps to increase awareness of potential counterfeit products. corporate press statement This is posted on our U.S. corporate website and includes a guide to spotting counterfeit products,” a Novo Nordisk spokesperson said in an email.
But it’s unclear whether all of Novo Nordisk’s reports to the FDA’s adverse event system include counterfeit products intended to trick people into thinking they’re buying authentic Ozempic.
One entry tagged “False Product Labels” references the year 2020. letter A report from a British doctor who treated a patient who had purchased only a product called “Skinny Pen Plus” online.
FDA has also expressed concern about alternatives to semaglutide, some of which are manufactured by Pharmaceuticals compounder Like a pharmacy. Compounders are allowed to sell unapproved semaglutide to Americans during the shortage period, but they do not have the same level of FDA oversight as Ozempic and Wigovy.
“FDA is seeing an increase in the number of adverse event reports and complaints regarding these combination drugs,” the agency said in a written statement. letter It was reported to the Pharmacy Committee last month.