Food and medication administration urged patients and doctors on Monday to verify that their Ozempic recipes are legitimate after the agency seized several hundred units of false versions of the diabetes medicine in the United States.
Novo Nordisk, the Ozempic manufacturer and the weight to lose weight Wegovy, told the FDA on April 3 that the falsified injections of 1 milligram were distributed outside their authorized supply chain in the United States, the agency said in a press release. That means that it probably entered the market through unofficial means, such as unauthorized distributors or resellers.
The FDA said it seized the counterfeit products, labeled with the Lot PAR0362 and the serial numbers that begin with the first eight digits 51746517, on April 9.
The agency said it is aware of six reports of adverse events linked to the lot; However, none of them seems to be associated with the falsified product. The agency and Novo Nordisk are testing false products to identify if they are safe. Genuine Ozempic can come with side effects, including stomach problems, so it is not clear if adverse events were caused by typical use.
False versions underline the very high popularity and demand for the Ozempic diabetes drug, which is often used “label out of place” to lose weight, as well as similar glp-1 medications.
In December 2023, the agency said it seized thousands of false Ozempic units and warned that some may still be available for purchase.
False products are different from the compound versions of the drug, which have also grown in popularity in the United States.
The FDA allows compound versions that are “essentially a copy” of drugs commercially available in special circumstances, such as shortage.
In February, the agency said that a shortage of Ozempic and Wegovy had been resolved in the United States, effectively ending the sale of the less expensive compound versions of drugs.
