The Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk’s diabetes drug Ozempic that have been found in the country’s supply chain.
The FDA said it will continue to investigate counterfeit 1-milligram Ozempic injections and that, although it has seized thousands of units, some may still be available for purchase.
Danish manufacturer Novo Nordisk and the FDA are analyzing the seized products and do not yet have information on the identity, quality or safety of the drugs, according to the agency.
Novo said the seizures took place in warehouses outside the authorized supply chain of the company.
The agency noted that the seized injection needles are counterfeit and their sterility cannot be confirmed, posing an additional risk of infection to patients.
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Other confirmed counterfeit components of the seized products include the pen label and accompanying information about the healthcare professional and the patient, as well as the carton packaging.
The FDA urged drug distributors, retail pharmacies, healthcare professionals, and patients to verify any medication they have received and not distribute, use, or sell. units labeled with lot number NAR0074 and serial number 430834149057.
People who have Ozempic injections with the lot number and serial number listed can report them directly to the FDA Office of Criminal Investigations.
The regulatory body stated that it was aware of five adverse events resulting from the use of the medication belonging to this batch, but all of them coincided with known side effects related to the authentic Ozempic.
Demand for Wegovy and Ozempic is outstripping Novo’s supply in the United States, Germany and Britain, prompting the company to restrict the supply of certain Wegovy doses to the U.S. market.
Although only Wegovy is approved for obesity, its diabetes counterpart, Ozempic, also produces dramatic weight loss, which has led people in the United States and Europe to use the drug. off-label, that is, not for approved use.
