Fake Ozempic Floods Market as FDA Warns Patients to Check Authenticity of Prescriptions

The Food and Drug Administration (FDA) advised patients and healthcare providers to verify the authenticity of their Ozempic prescriptions after the agency confiscated several hundred counterfeit units of the diabetes medication in the United States. According to an FDA news release, Novo Nordisk, the manufacturer of Ozempic and the weight loss drug Wegovy, notified the agency that counterfeit 1-milligram injections were circulating outside its authorized supply chain in the U.S. This suggests the products likely entered the market through unauthorized distributors or resellers.

Counterfeit Lot Under Investigation as FDA and Novo Nordisk Assess Safety Risks

The FDA reported seizing counterfeit Ozempic products labeled with lot number PAR0362 and serial numbers beginning with the first eight digits 51746517. The agency received six adverse event reports linked to this lot, but it found no direct connection to the counterfeit versions. The FDA and Novo Nordisk are currently testing the fake products to determine their safety. 

In return, the FDA advises wholesalers, pharmacies, healthcare providers, and patients to inspect their products and refrain from distributing, using, or selling any items labeled with lot number NAR0074 and serial number 430834149057. Some counterfeit products may still be available for purchase.

Analysis also confirmed that the needles in the seized samples are counterfeit, raising concerns about sterility and increasing the risk of infection for patients who use these products. Additional counterfeit components identified include the pen label, the healthcare professional and patient information, and the carton.

Reports link five adverse events to this lot. Health officials do not consider any of the adverse events serious, and they identify all as consistent with common side effects of authentic Ozempic, including nausea, vomiting, diarrhea, abdominal pain, and constipation.

Image source: FDA

Agency Resolves Ozempic and Wegovy Shortages

In December 2023, the agency announced the seizure of thousands of counterfeit Ozempic units and cautioned that some may still be on the market. These counterfeit products differ from compounded versions, which have become more common in the U.S. The FDA permits compounded versions of drugs that closely resemble commercially available medications in certain situations, such as when there is a shortage. However, in February, the agency stated that the Ozempic and Wegovy shortages in the U.S. had been resolved, effectively discontinuing the sale of less expensive compounded alternatives.

“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand. No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients,” said Dave Moore, Executive Vice President, U.S. Operations and Global Business Development and President of Novo Nordisk Inc.

Federal law requires the FDA to maintain an updated list of drugs in shortage, defined as situations where demand exceeds supply. To keep this list current, the agency reviewed data from Novo Nordisk, including information on production, inventory, projected supply and demand, and wholesaler stock levels. The agency also considered input from other sources, such as telehealth companies, pharmacy compounders, and outsourcing facilities. Based on this review, the FDA determined that Novo Nordisk’s supply of semaglutide is currently meeting or exceeding demand, with reserves in both finished and semi-finished products to meet future demand. While the FDA evaluated additional information from other sources, it concluded that this did not outweigh the evidence that Novo Nordisk can meet both current and projected demand.

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Denisse Sandoval