FDA seizes thousands of units of counterfeit Ozempic

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

The FDA and Novo Nordisk, which makes Ozempic, are now testing the seized drugs to find out what’s in them. So far, the agency has confirmed that the needles that come with these injectable drugs are counterfeit and may not be sterile. Also, labeling, packaging, and accompanying information to patients and healthcare providers are all deceptive.

The agency has linked five adverse events to a single batch of Ozempic that contained counterfeit drugs. However, regulators have not determined whether these problems were directly caused by counterfeit drugs; the symptoms were similar to the common side effects of Ozempic, such as nausea and abdominal pain.

The FDA shared photos of the counterfeit injections and encouraged patients to check their medications for possible fakes. For example, a real Ozempic needle should be covered with a strip of paper that says NovoFine Plus, while the fake ones found so far only say NovoFine. Consumers can also compare the batch and serial number of the drug with counterfeit drugs or ask the pharmacy for help in identifying this information.

It’s rare for a counterfeit drug to get past pharmacies or other security measures and into the hands of patients, said Shabbir Imber Safdar of the Partnership for Safe Medicines, a nonprofit coalition that advocates to protect consumers from counterfeit and dangerous drugs.

But the shortage could prompt pharmacies to buy from distributors they may not know, he said, potentially 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 track and authenticate drugs throughout the supply chain, criminal distributors have become increasingly adept at making counterfeit drugs that can bypass those barriers, he added.

A Novo Nordisk representative wrote in a statement that the counterfeit Ozempic products were seized from warehouses outside Novo Nordisk’s authorized supply chain. The FDA said the counterfeit drugs had been found in the legitimate drug supply chain.

There is also concern that counterfeit Ozempic comes from sources outside the supply chain. As Ozempic and similar drugs have grown in popularity, there has been an explosion in the number of these various online sellers where you can skip the prescription altogether, said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who studies obesity.

Medicines on some direct-to-consumer websites may come from the gray market or from unlicensed sellers who operate outside authorized networks, said Timothy Mackey of the University of California, San Diego, who studies counterfeit drugs. Essentially, the gray market manufacturer is simply responding to market demand, he said. And sometimes the product is fake or worse.

Counterfeit Ozempic has also been a problem abroad: In Austria, several people were hospitalized after using fake Ozempic, and in Lebanon, 11 people developed dangerously low blood sugar after taking drugs deemed to be fake, reports Reuters.

The FDA has also received reports of adverse events in patients taking combinations of semaglutide, an ingredient in Ozempic. Health authorities have warned against the use of medicines containing these compounds.

The agency has urged people to get their medicine from state-approved pharmacies. In general, experts say it’s wise to always get Ozempic with a prescription and beware of drugs that claim to be Ozempic, which sell for much less than the brand-name version’s list price of about $900.

There is no trade in the drugs, including Ozempic, Mr. Safdar said. Trade is dangerous.

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