The US Food & Drug Administration has launched a probe after at least three people were admitted to hospitals after using suspected counterfeit semaglutide drugs.
Since frenzied sales of Ozempic and Wegovy – both semaglutide medications from Novo Nordisk – for their use in weight loss, the drugs have been in short supply for months.
The hospitalisations are among 42 reports to the FDA’s Adverse Event Reporting System that mention use of counterfeit semaglutide from around the world, reports CBS News.
Of the reports, 28 are classified as “serious”, with outcomes that also include deaths.
The records do not prove whether the counterfeits caused the complaints or might have been incidental to the reports.
The reports come as authorities worldwide say they have been battling a wave of these counterfeit drugs.
Late last month, the FDA’s British counterpart – the Medicines and Health Products Regulatory Agency – said it had seized hundreds of “potentially fake Ozempic pens since January”.
The agency said it had also received reports of “a very small number who have been hospitalised” after using the counterfeits.
The FDA has also been investigating schemes trafficking counterfeit pens into American pharmacies, according to an industry trade group’s warning.
What counts as counterfeit?
In June, Novo Nordisk said it was working with the FDA after a pharmacy in the US sold an Ozempic pen that turned out to be counterfeit. It said there were some tell-tale differences that could help patients detect a counterfeit.
"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 on our US corporate website which includes a guide for identifying counterfeits,” a Novo Nordisk spokesperson said.
The FDA has also voiced concerns over semaglutide alternatives, some of which are manufactured by drug compounders like pharmacies.
While compounders are allowed to sell unapproved semaglutide to Americans during the shortage, those aren’t subject to the same level of FDA oversight as Ozempic and Wegovy.
“FDA has received an increased number of adverse event reports and complaints concerning these compounded drug products,” the agency wrote last month to pharmacy boards.
CBS News article – FDA investigating reports of hospitalizations after fake Ozempic (Open access)
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