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FDA Issues Alert on Fake Ozempic Diabetes Medication by Novo Nordisk

FDA Warning Against Counterfeit Ozempic

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The U.S. Food and Drug Administration issued a warning to consumers about counterfeit versions of Novo Nordisk’s diabetes drug, Ozempic. These fake drugs have been found in the U.S. drug supply chain.

Ongoing Investigation and Seizures

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The FDA is investigating counterfeit Ozempic 1-milligram injections and has already seized thousands of units. However, there are concerns that some counterfeit products may still be available for purchase.

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Collaboration Between Novo Nordisk and FDA

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Novo Nordisk, the Danish drugmaker, is working with the FDA to test the seized counterfeit products. Details about the drugs’ identity, quality, or safety are not yet available.

Counterfeit Products Found Outside Authorized Supply Chain

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Novo Nordisk confirmed that the counterfeit drug seizures occurred in warehouses outside their authorized supply chain. This raises concerns about the distribution of these fake drugs.

Health Risks from Counterfeit Needles

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The FDA highlighted that the needles from the seized counterfeit injections are also fake and their sterility is unconfirmed. This poses additional infection risks for patients using them.

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Identifying Counterfeit Components

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Confirmed counterfeit components from the seized products include the pen label, information for healthcare professionals and patients. Additionally, there are discrepancies in the packaging carton.

FDA’s Guidance to Check Drug Units

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The FDA has advised drug distributors, retail pharmacies, healthcare practitioners, and patients to check for specific lot and serial numbers. They should not distribute, use, or sell units labelled with lot number NAR0074 and serial number 430834149057.

Adverse Events Linked to Counterfeit Lot

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The regulator reported five adverse events associated with the use of the drug from this particular lot. However, these events were consistent with side effects known from authentic Ozempic.

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High Demand for Wegovy and Ozempic

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Demand for Wegovy and Ozempic has exceeded Novo Nordisk’s supply capabilities in the U.S., Germany, and Britain. This has led to supply restrictions for certain doses of Wegovy in the U.S. market.

Off-Label Use of Ozempic for Weight Loss

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Though Wegovy is the only drug approved for obesity, Ozempic, primarily a diabetes drug, has also been found to cause significant weight loss. This has resulted in its off-label use in the U.S. and Europe.

Risks of Off-Label Drug Use

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The off-label use of Ozempic underscores the risks associated with using medications beyond their approved purposes. Consumers are advised to be cautious and consult healthcare professionals.

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Conclusion and Public Health Advisory

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The FDA’s warning is a critical reminder of the dangers of counterfeit drugs in the healthcare system. Consumers and healthcare providers are urged to remain vigilant to ensure patient safety.

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