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, the company that makes Ozempic, are now testing the seized drugs to find out what they contain. So far, the agency has confirmed that the needles that come with these injectable drugs are counterfeit and may not be sterile. Labels, packaging and associated information for patients and health care providers are also fraudulent.

The agency has linked five adverse events to the same lot of Ozempic that contained the counterfeit drug. However, regulators have not determined whether these problems were directly caused by the counterfeit drugs; Symptoms were similar to common side effects of Ozempic, such as nausea and stomach pain.

The FDA shared photos of counterfeit injectors and encouraged patients to check their medication for signs that it may be counterfeit. For example, a genuine Ozempic needle should be covered with a paper tab that says Novofine Plus, whereas the counterfeit needles found so far only have Novofine written on it. Consumers can also compare a drug’s lot and serial number with counterfeit drugs, or ask a pharmacist for help identifying that information.

It’s rare for counterfeit drugs to get past pharmacists or other safeguards and into the hands of patients, said Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, a nonprofit coalition that advocates to protect consumers against counterfeit and unsafe medicines. Is.

But shortages could force 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 Vegovy, which contain the same compound, are in short supply. He said that while the FDA has strengthened its systems to trace and verify drugs in the supply chain, criminal distributors have become increasingly adept at creating counterfeit drugs that can bypass those barriers.

A representative for 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 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 drugs have become increasingly popular, there’s been an explosion of these different online vendors where you can get prescription drugs at your doctor’s office, said Dr. Scott Hagen, an assistant professor of medicine at the University of Washington who studies obesity. The prescription can be completely ignored.

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

Counterfeit Ozempic has also been an issue abroad: According to Reuters, several people in Austria were hospitalized after using counterfeit Ozempic, and 11 people in Lebanon died after taking a drug believed to be counterfeit. Had developed low blood sugar.

The FDA has also received reports of adverse events in patients taking mixed versions of semaglutide, the substance in Ozempic. Health officials have warned against the use of these mixed medicines.

The agency has urged people to buy their medications from state-licensed pharmacies. In general, experts say, it is wise to always get Ozempic with a prescription and to be wary of drugs claiming to be Ozempic for sale at a price far lower than the nearly $900 list price of the brand-name version. .

There is no bargaining for drugs including Ozempic, Mr Safdar said. The deal is in danger.

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