The U.S. Food and Drug Administration has seized thousands of units of fake Ozempic, the agency said Thursday, warning that some counterfeit units of the Novo Nordisk
NVO,
diabetes drug may still be available for purchase.
Novo Nordisk and the FDA are testing the seized products and do not yet have details on their quality or safety, the agency said. The needles from the samples are also counterfeit, the FDA said, meaning they pose a risk of infection because their sterility cannot be confirmed.
Patients should check any products they have received for the lot and serial numbers identified with the counterfeit products, which are posted on the FDA’s site, the agency said.
There have been at least five adverse events linked with the counterfeit products, the FDA said, which have been consistent with common Ozempic side effects such as nausea and vomiting.
Novo Nordisk said in a statement that it is “committed to supporting the active fight against counterfeit Novo Nordisk products and other illegal activity in the market.” The company said it is working with the FDA to identify other potential knock-off products in the U.S.
The Danish drugmaker has taken a series of steps this year to combat fake products amid the surging popularity of GLP-1 drugs widely used for weight loss. Novo Nordisk said in June, for example, that it was taking legal action against medical spas, wellness clinics and compounding pharmacies over alleged false advertising, trademark infringement or unlawful sales of compounded products claiming to contain semaglutide, the active ingredient in Ozempic and Wegovy.
The European Medicines Agency also warned in October that fake Ozempic had been identified at wholesalers in the European Union and the United Kingdom.
Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for any signs of counterfeiting, the FDA said.
The counterfeit Ozempic needles recently identified have a blue transparent inner needle cover and a paper tab that says “NovoFine,” the FDA said. Authentic Ozempic needles have a transparent inner needle cover and a paper tab that says “NovoFine Plus,” according to the agency.
Novo Nordisk’s American depositary receipts fell 0.2% Friday and have gained 52% in the year to date, while the S&P 500
SPX
is up 24%.
