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• Posted November 8, 2023

FDA Investigating Hospitalizations Linked to Counterfeit Ozempic

The U.S. Food and Drug Administration has received at least three reports of people being hospitalized after taking counterfeit versions of the wildly popular weight-loss drugs known as semaglutides.

At least one of these reports includes mention of a counterfeit version of the Novo Nordisk medication Ozempic, CBS News reported.

Ozempic and Wegovy, another semaglutide medication made by Novo Nordisk, have been tough to find for months as millions of Americans turn to them for weight loss.

In total, 42 reports that mention the use of counterfeit semaglutide were submitted to the FDA's Adverse Event Reporting System through the end of September, CBS News reported. Of those, 28 were classified as "serious," with outcomes that included deaths. All were submitted to the FDA by Novo Nordisk.

However, the records do not prove the counterfeits directly caused the adverse events.

An FDA spokesperson told CBS News that the agency has "no new information to share regarding reports of adverse events" linked to semaglutide counterfeits.

"The FDA will investigate any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats," agency spokesperson Jeremy Kahn told CBS News.

Meanwhile, Novo Nordisk has said that it is working with the FDA to make consumers aware of the counterfeits and how they differ from the company's products.

"In close collaboration with FDA, we have taken measures to create awareness of the potential for counterfeit products. We have developed a company statement that... includes a guide for identifying counterfeits," a Novo Nordisk spokesperson told CBS News.

The FDA has also voiced concerns over semaglutide alternatives, some of which are manufactured by drug compounders. While compounders are allowed to sell unapproved semaglutide to Americans during the shortage, those aren't scrutinized as carefully as Ozempic and Wegovy are, CBS News reported.

The "FDA has received an increased number of adverse event reports and complaints concerning these compounded drug products," the agency wrote in a letter sent last month to pharmacy boards.

More information

Visit the FDA for more on semaglutide medications.

SOURCE: CBS News