FDA investigating reports of hospitalizations after fake Ozempic

At least three Americans were reportedly hospitalized after using suspected counterfeit semaglutide medications, including Novo Nordisk’s diabetes drug Ozempic, according to records released by the Food and Drug Administration.

Ozempic and Wegovy, another semaglutide drug from Novo Nordisk, have been in shortage for months amid booming sales for their use in weight loss.

These hospitalizations are among 42 reports submitted to the FDA’s Adverse Event Reporting System that mention the use of counterfeit semaglutide of the whole world. The agency last updated its database late last month to include reports tallied through the end of September.

Of these reports, 28 are classified as “serious,” with consequences that also include deaths.

Only a portion of these specifically mention Ozempic, including one of three hospitalizations in the United States. All were submitted to the FDA by Novo Nordisk, citing reports to the company from consumers or health care providers.

The records do not prove whether the counterfeits are the cause of the complaints or whether they could have been incidental to the report.

An FDA spokesperson said the agency had “no new information to share regarding reports of adverse events” related to counterfeit semaglutide.

“The FDA will investigate any reports of suspected counterfeit drugs to determine the risks to public health and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats,” said Jeremy Kahn, the spokesperson. -speech, in an email.

The reports come as authorities around the world say they are battling a wave of these counterfeit drugs.

Late last month, the FDA’s UK counterpart – the Medicines and Healthcare products Regulatory Agency – said it had seized hundreds of “potentially fake Ozempic pens since January 2023”.

The agency said it had also received reports of “a very small number of people hospitalized” after using the counterfeits.

The FDA also investigated plans to traffic counterfeit pens into U.S. pharmacies, according to an industry trade group report. warning, previously reported by CBS News.

What constitutes counterfeiting?

In June, Novo Nordisk said it was working with the FDA after a U.S. retail pharmacy sold an Ozempic pen that turned out to be counterfeit.

This drug was packaged in a fake label and carton that could be mistaken for an authentic Ozempic pen from Novo Nordisk, although the drugmaker said there were telling differences that could help patients understand that they had bought a counterfeit.

“Working closely with the FDA, we have taken steps to raise awareness of the potential of counterfeit products. We have developed a company press release which is posted on our US company website and includes a guide to identifying counterfeits,” said a Novo Nordisk spokesperson. in an email.

However, it is unclear whether all of Novo Nordisk’s reports to the FDA’s adverse event system include counterfeits designed to fool people into thinking they were purchasing authentic Ozempic.

One entry – labeled as “product label counterfeit” – refers to a 2020 letter from British doctors who had treated a patient who purchased a product online called only “skinny pen plus”.

The FDA has also expressed concerns about alternatives to semaglutide, some of which are made by drugmakers like pharmacies. Although compounders are allowed to sell unapproved semaglutide to Americans during the shortage, they are not subject to the same level of FDA oversight as Ozempic and Wegovy.

“The FDA has received an increasing number of adverse reaction reports and complaints regarding these compounded drug products,” the agency wrote in a letter last month to boards of pharmacy.