TRENTON, NJ – The U.S. Food and Drug Administration (FDA) issued a warning on Thursday against counterfeit versions of Novo Nordisk’s diabetes drug, Ozempic, which have infiltrated the U.S. drug supply chain. The FDA is actively investigating counterfeit Ozempic 1 milligram injections and has already seized thousands of units. Despite these efforts, some counterfeit products may still be available for purchase.
The FDA warns supplies could be tainted even in the New Jersey and New York area.
Novo Nordisk, the Danish pharmaceutical company that manufactures Ozempic, confirmed that the seizures occurred outside their authorized supply chain. The FDA and Novo Nordisk are currently analyzing the seized products to determine their composition, quality, and safety, but this information is not yet available.
A significant concern raised by the FDA is the sterility of the needles in the seized injections. These counterfeit needles cannot be verified for sterility, posing an additional infection risk for patients. Furthermore, other components, including the pen label, patient and healthcare professional information, and the product carton, have also been confirmed as counterfeit.
The FDA has advised drug distributors, retail pharmacies, healthcare practitioners, and patients to verify the Ozempic they have received, specifically advising against the distribution, use, or sale of units labeled with lot number NAR0074 and serial number 430834149057. While the regulator acknowledged five adverse events linked to this lot, they noted that these were consistent with the known side-effects of authentic Ozempic.
This warning comes amid a high demand for Ozempic and its counterpart, Wegovy, in the United States, Germany, and Britain. The demand has surpassed Novo Nordisk’s supply capacity, leading to restricted supplies of certain Wegovy doses in the U.S. market. Although Ozempic is primarily a diabetes medication, its off-label use for dramatic weight loss has become popular in the U.S. and Europe, contributing to the heightened demand.