The U.S. Food and Drug Administration (FDA) has issued a stark warning to consumers, cautioning against the use of counterfeit versions of Novo Nordisk’s diabetes drug, Ozempic.
The FDA disclosed that these counterfeit drugs, particularly the Ozempic 1 milligram injections, have infiltrated the country’s drug supply chain. While the regulatory body has seized thousands of units, it raised concerns that some may still be available for purchase.
• Investigation in Progress: The FDA is actively investigating the counterfeit Ozempic injections and has seized numerous units. However, the agency noted that it is an ongoing process, and consumers should remain vigilant.
• Identity, Quality, and Safety Concerns: Novo Nordisk and the FDA are currently testing the seized products, but as of now, there is no information about the identity, quality, or safety of these counterfeit drugs. The seizures reportedly occurred outside Novo Nordisk’s authorized supply chain.
• Risk of Infection: The needles from the seized injections have been confirmed as counterfeit, raising concerns about their sterility. The FDA highlighted the additional risk of infection for patients using these counterfeit drugs.
• Confirmed Counterfeit Components: Apart from counterfeit needles, other confirmed counterfeit components include the pen label, accompanying information about the healthcare professional and patient, as well as the carton.
• Specific Lot Warning: The FDA specifically urged drug distributors, retail pharmacies, healthcare practitioners, and patients to check for units labeled with lot number NAR0074 and serial number 430834149057. The agency is aware of five adverse events related to this specific lot, but they align with known side-effects of authentic Ozempic.
• Supply Constraints: Novo Nordisk is facing high demand for both Wegovy and Ozempic, with supply shortages in the United States, Germany, and Britain. To manage this, the company has restricted supplies of certain doses of Wegovy to the U.S. market.
• Off-Label Use: While Wegovy is approved for obesity, Ozempic is also known to lead to significant weight loss. This has resulted in off-label use, with individuals in the United States and Europe leveraging the drug for its weight loss effects.
The FDA’s warning underscores the critical need for consumers and healthcare professionals to exercise caution and verify the authenticity of Ozempic units in the wake of these counterfeit drugs infiltrating the market.