FDA seizes thousands of units of counterfeit Ozempic

The Food and Drug Administration said Thursday that it had seized thousands of units of counterfeit Ozempic, the diabetes drug also widely used for weight loss. Some fraudulent Ozempic products may still be on the market, according to the agency.

The FDA and Novo Nordisk, the company that makes Ozempic, are now testing the seized medications to determine what is in them. So far, the agency has confirmed that the needles accompanying these injectable medications are counterfeit and may not be sterile. The labels, the packaging and the accompanying information for patients and health care providers are also all fraudulent.

The agency has linked five adverse events to a single lot of Ozempic that contained counterfeit medication. However, regulators have not determined if those issues were directly caused by the fake drugs; the symptoms were similar to common side effects of Ozempic, like 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 real Ozempic needle should be covered by a paper tab that reads “NovoFine Plus,” while the counterfeit needles found so far simply say “NovoFine.”

Consumers can also compare the lot and serial number of the medication with those of the counterfeit drugs or ask a pharmacist for help identifying that information.

It is rare for a counterfeit drug to make it past pharmacists or other safeguards and into a patient’s hands, said Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, a nonprofit coalition that advocates protecting consumers against counterfeit and unsafe medicines.

But shortages can drive 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 challenges; some doses of Ozempic and Wegovy, which contain the same compound, are in short supply. And while the FDA has strengthened its systems to trace and verify drugs across the supply chain, criminal distributors have become increasingly skilled at making fake medications that can bypass those barriers, he added.

A representative from Novo Nordisk wrote in a statement that the counterfeit Ozempic products were seized “in warehouses outside the Novo Nordisk authorized supply chain.” The FDA said that the counterfeit medications had been 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 drugs have grown increasingly popular, there has “been an explosion of these different online vendors where you can bypass a prescription altogether,” said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who studies obesity.

Drugs from some of these direct-to-consumer websites may come from the “gray market,” or unlicensed sellers that operate outside authorized networks, said Timothy Mackey, a professor at the University of California, San Diego, who studies counterfeit medications. “Essentially, what’s happening is, a gray market manufacturer is simply meeting a market demand,” he said. “And sometimes that product is going to be counterfeit or substandard.”

Counterfeit Ozempic has been an issue abroad as well: Several people in Austria were hospitalized after using counterfeit Ozempic, and 11 people in Lebanon developed dangerously low blood sugar after taking medication that was believed to be fake, according to Reuters.

The FDA has also received reports of adverse events among patients taking compounded versions of semaglutide, the substance in Ozempic. Health officials have warned against using these compounded medications.

The agency has urged people to acquire their medication from 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 for sale at a far lower cost than the roughly $900 list price of the brand-name version.

“There is no bargain to be had for medicine, including Ozempic,” Safdar said. “The bargain is danger.”

This article originally appeared in The New York Times.