FDA seizes thousands of units of counterfeit Ozempic
The Food and Consumer Product Safety Authority said Thursday that it had seized thousands of units of counterfeit Ozempic, the diabetes drug also widely used for weight loss. According to the agency, fraudulent Ozempic products may still be on the market.
The FDA and Novo Nordisk, the company that makes Ozempic, are now testing the seized drugs to determine what is in them. So far, the agency has confirmed that the needles supplied with these injectable medications are counterfeit and may not be sterile. The labels, packaging and associated information for patients and healthcare providers are also fraudulent.
The agency has linked five adverse events to one batch of Ozempic that contained counterfeit medications. However, regulators did not determine whether these problems were directly caused by the fake drugs; the symptoms were similar to the common side effects of Ozempic, such as nausea and stomach pain.
The FDA shared photos of the fake injectors and encouraged patients to check their medication for signs that it could be counterfeit. For example, a genuine Ozempic needle must be covered by a paper tab that says ‘NovoFine Plus’, while counterfeit needles found so far simply say ‘NovoFine’. Consumers can do that too compare the lot and serial numbers of the medication with that of the counterfeit drugs, or ask a pharmacist for help identifying that information.
It’s rare for a counterfeit drug to make it past pharmacists or other safeguards and into a patient’s hands, said Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, a nonprofit coalition that advocates for consumer protection against counterfeit and unsafe medications.
But shortages can prompt pharmacies to buy from distributors they may not be familiar with, he said, putting them at risk of buying counterfeits. Ozempic and similar drugs have faced supply issues; some doses of Ozempic and Wegovy, which contain the same substance, are shortages. And while the FDA has strengthened its systems track and verify Throughout the drug supply chain, criminal distributors have become increasingly adept at creating fake drugs that can bypass these barriers, he added.
A Novo Nordisk representative wrote in a statement that the counterfeit Ozempic products were seized “in warehouses outside Novo Nordisk’s authorized supply chain.” The FDA said the counterfeit drugs were found in the legitimate drug supply chain.
There are also concerns about the risk of counterfeit Ozempic coming from sources outside that supply chain. As Ozempic and similar medications have become increasingly popular, there’s been “an explosion of these different online vendors where you can bypass a prescription altogether,” says Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who researches obesity.
Medicines from some of these direct-to-consumer websites may come from the “gray market,” or unlicensed sellers operating outside authorized networks, said Timothy Mackey, a professor at the University of California, San Diego, who investigates counterfeit drugs. “Essentially what’s happening is a gray market manufacturer is simply meeting a market demand,” he said. “And sometimes that product will be counterfeit or substandard.”
Counterfeit Ozempic is also a problem abroad: several people in Austria have been hospitalized after taking counterfeit Ozempic, and 11 people in Lebanon developed dangerously low blood sugar levels after taking drugs believed to be fake, according to Reuters.
The FDA has also received reports of side effects in patients taking compounded versions of semaglutide, the substance in Ozempic. Health officials have done just that which has been warned against use of these compounded medications.
The agency has urged people to buy their medications state-licensed pharmacies. In general, experts say it is wise to always obtain Ozempic with a prescription and to be wary of drugs claiming to be Ozempic that can be purchased at a much lower cost than the approximately $900 list price of the brand-name version.
“There is no bargain to be had on medicines, including Ozempic,” Mr Safdar said. “The deal is danger.”