FDA issues fake Ozempic warning as ‘thousands of units’ already seized

The US Food and Drug Administration has said counterfeits of the popular drug Ozempic may still be in the drug supply chain and warned wholesalers, retail pharmacies, healthcare workers and patients to be aware of the products.

The FDA said Americans should check the products and if they find those with lot number NAR0074 and serial number 430834149057, they should stop distributing or using them. The agency said it is continuing to investigate the matter and has succeeded in seizing thousands of counterfeit units, but there may still be more in the drug supply chain.

“Some counterfeit products may still be available for purchase,” the FDA said in a statement last week.

Newsweek reached out to the FDA via email for comment on Monday.

This photo taken on Feb. 23, 2023 in Paris shows the diabetes medicine ‘Ozempic’ (semaglutide) manufactured by the Danish pharmaceutical company ‘Novo Nordisk’. The US Food and Drug Administration warned consumers that there are counterfeit drugs in the US drug supply chain. (Photo by JOEL SAGET/AFP via Getty Images)

Ozempic and other similar drugs have gained significant popularity among people who use it for weight loss. The drug has not yet been approved by the FDA for the treatment of obesity and was only approved in 2017 for the treatment of diabetes. But another drug containing semaglutide, such as Ozempic, Wegovy, has received approval to treat obesity. Both products are manufactured by the Danish company Novo Nordisk.

The FDA said it is working with Novo Nordisk to test the seized counterfeit drugs, but has yet to reach a conclusion on the nature and safety of the drugs.

However, the agency said it was aware of five adverse drug reactions.

“None of them are serious and correspond to the known common side effects of genuine Ozempic, which include nausea, vomiting, diarrhea, abdominal pain, and constipation,” the FDA said in a statement.

The fake products contained needles that were also not genuine and could pose a risk of infection, the agency warned.

“Based on analysis to date, other confirmed counterfeit parts of the seized products include the pen label, accompanying healthcare professional and patient information, and the box,” the FDA said.

The Medicines Authority urged pharmacies to obtain Ozempic directly from authorized Novo Nordisk distributors and to take all precautions to ensure that the products they receive are genuine.

“Patients should obtain Ozempic only with a valid prescription from state-licensed pharmacies and check the product for counterfeits before use,” the FDA said.

The agency also encouraged Americans to report any adverse drug effects to the regulator.

“Companies, including online sellers, that sell fake and/or counterfeit drugs should be reported to the FDA,” they said.

Ozempic and Wegovy have become quite popular among celebrities and consumers, which has significantly increased Novo Nordisk’s business. In November, the company reported that the operating profit improved by about a third, and the sales of the North American operations increased by almost 50 percent from September 2023.

“We are very pleased with the sales growth in the first nine months of 2023, which shows that more people than ever are benefiting from our innovative diabetes and obesity treatments,” company CEO Lars Fruergaard Jørgensen said at the time. opinion.