FDA Warns of Fake Ozempic and Confiscates ‘Thousands’ of Units

The US Food and Drug Administration (FDA) has taken swift action after seizing numerous counterfeit units of weight-loss and diabetes drug Ozempic. The agency issued a warning to consumers in light of the recent discovery of fake versions of the medication. The counterfeit drugs pose significant risks to public health and safety.

According to a news release by FDA, “thousands of units of the product” containing semaglutide were seized from the legitimate US drug supply chain. The agency urged wholesalers, retail pharmacies, healthcare practitioners, and patients to check the product they have received and avoid distributing, using, or selling products with the lot number NAR0074 and serial number 430834149057. The FDA highlighted that some counterfeit drugs may still be available on the market.

Additionally, the needles provided with the counterfeit drugs appear to be fake, posing an increased risk of infection for patients. Although the FDA listed some “adverse events” connected to the counterfeit lot, it did not classify any of them as serious. The reactions were described as consistent with known common adverse reactions to authentic Ozempic.

The FDA emphasized that the investigation into the counterfeit drugs is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US. Patients and individuals seeking weight-loss treatment are advised to obtain the drug with a valid prescription through a state-licensed pharmacist or pharmacy. It was also recommended to check the product to identify signs of counterfeiting.

The FDA notified that entities selling counterfeit and/or tampered medicines should be reported to the agency. Demand for Wegovy and Ozempic is exceeding Novo’s supply, leading the company to limit supplies of certain doses of Wegovy to the US market. The FDA had also previously warned about potential adverse reactions to Ozempic and Wegovy, updating the products’ labels to make note of reports that the drugs can interrupt the normal function of the intestines in some people.

The label update noted a significant number of reports of gastrointestinal problems in those taking the drugs. The warnings came after a woman in Louisiana filed a lawsuit accusing the manufacturer of Ozempic of failing to disclose the risk of causing inflammation of the stomach lining as well as stomach paralysis after using the drug.

The FDA is seriously considering reports of potential counterfeit products and collaborating with federal agencies and the private sector to protect the nation’s drug supply.

In conclusion, the public is urged to remain vigilant and report any suspected counterfeit products to the FDA. The health and safety of consumers are of paramount importance, and the FDA is committed to ensuring the integrity of the drug supply chain. The agency’s investigation into counterfeit drugs is ongoing, and further updates and advisories will be provided as the situation develops.

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