FDA probes hospitalizations tied to fake Ozempic

The FDA is investigating reports of hospitalizations tied to suspected counterfeit versions of semaglutide drugs, including three in the U.S., according to records from the agency's adverse event reporting system. 

According to a Nov. 7 report from CBS News, the FDA updated its Adverse Event Reporting System last month to include reports through the end of September. Forty-two hospitalizations from around the world that mention the use of counterfeit semaglutide were reported, 28 of which were classified as "serious." A portion of the adverse event reports mention Ozempic specifically, including two of the three hospitalizations in the U.S. All the reports were submitted by Novo Nordisk, the maker of Ozempic and Wegovy. 

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

It is not clear whether all of Novo Nordisk's reports to the agency were about counterfeit versions specifically designed to come off as authentic Ozempic pens. The drugmaker started working with federal regulators in June after a retail pharmacy in the U.S. sold what appeared to be an Ozempic pen, though it turned out to be fake. 

"In close collaboration with FDA, we have taken measures to create awareness of the potential for counterfeit products. We have developed a company press statement that is posted on our U.S. corporate website and includes a guide for identifying counterfeits," a Novo Nordisk spokesperson told CBS News

Last month, the news outlet obtained a warning letter from an industry trade group that indicated the FDA has started investigating schemes to sell phony versions of Ozempic to unsuspecting pharmacies. 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars