The U.S. Food and Drug Administration has said that counterfeit of the popular drug Ozempic may still be in the drug supply chain and warned wholesalers, retail pharmacies, healthcare workers and patients to be mindful of the products.
The FDA said that Americans should check the products and if they find them labeled with a lot number NAR0074 and serial number 430834149057 they should cease their distribution or use. The agency said it is continuing to investigate the issue and has managed to seize thousands of the counterfeit units but that 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.
Ozempic, and other similar drugs, have gained significant popularity with people using it for weight loss. The FDA has yet to sanction the use of the drug for anti-obesity treatment and it only gained approval in 2017 for the treatment of diabetes. But another drug with semaglutide like Ozempic, Wegovy, has received approval to treat obesity. Both products are produced by the Danish company Novo Nordisk.
The FDA said that it was working with Novo Nordisk to test the seized counterfeit drugs but has yet to come to a conclusion about the nature of the drugs and their safety.
The agency said, however, that it was aware of five adverse effects of the drugs.
“None of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation,” the FDA said in its statement.
The counterfeit products had needles that were also not authentic and could present a risk of infection, the agency warned.
“Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton,” the FDA said.
The drugs regulator implored pharmacies to procure Ozempic directly from approved Novo Nordisk distributors and take all precautions to ensure that the products they receive are authentic.
“Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using it for any signs of counterfeiting,” the FDA said.
The agency also encouraged Americans to report to the regulator any negative effects from the drugs.
“Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA,” they said.
Ozempic and Wegovy has become quite popular with celebrities and the general consumer alike which has substantially boosted Novo Nordisk’s business. In November, the company reported that its operating profit improved by about a third and sales in its North America operations jumped by nearly 50 percent as of September of 2023.
“We are very satisfied with the sales growth in the first nine months of 2023, which is reflecting that more people than ever are benefiting from our innovative diabetes and obesity treatments,” Lars Fruergaard Jørgensen, president and CEO, of the company said then in a statement.
Tags: Counterfeit New Drug Trends Ozempic Safety Alert Semaglutide Supply Chain
