The FDA and Novo Nordisk are warning of counterfeit versions of popular weight-loss treatment Ozempic that have been discovered in the “legitimate” United States supply chain.
The U.S. regulator has notified distributors, pharmacies, healthcare professionals and patients not to use products labeled with the Lot number NAR0074 or the serial number 430834149057. These knockoffs come in a 1 mg injected dose. Thousands of units have been seized but some may still be in circulation, the FDA said.
Five users of products from the lot have reported adverse effects, though none are different from the widely known side effects of Ozempic, including nausea, diarrhea and vomiting. It's uncertain if all the products from the lot are counterfeit, Novo said in a statement.
“Novo Nordisk cannot guarantee the quality or safety of the counterfeit Ozempic product,” Novo added. “Visual analysis shows that needles and cartons appear to be counterfeit. Product composition has not been conclusively determined.”
The FDA and the company warned that counterfeit needles could present an increased risk of infection.
With the popularity of Novo’s semaglutide products and Eli Lilly’s tirzeptide—and the companies’ inability to satisfy the demand—fake versions of their treatments have been uncovered as well as authorized compounded versions of the drugs which contain unauthorized ingredients.
Last month, Novo sued two compounders in Florida. In October, health officials in the U.K. and Europe warned of falsified Ozempic pens. In September, Lilly sued 10 medical spas, wellness centers and compounding pharmacies for selling products they claimed were diabetes drug Mounjaro.
As demand has increased for the weight-loss drugs, sales have skyrocketed. In the third quarter, Lilly (38%) and Novo (29%) posted the largest year-over-year revenue increases in the industry. During the period, Ozempic and Wegovy combined for $4.7 billion in sales, which accounted for 57% of Novo’s revenue. Meanwhile, sales of Lilly’s Mounjaro’s reached $1.4 billion in the quarter.