The U.S. Food and Drug Administration (FDA) issues a new warning about the rise of counterfeit Ozempic in the American supply chain. This diabetes drug, manufactured by Novo Nordisk, has been facing shortages throughout most of 2023 due to its popularity as a weight loss aid. With the shortage, the FDA cautions that counterfeiters have seized the opportunity to introduce imitation products that may pose risks to consumers.
The FDA has taken action by confiscating thousands of units of the counterfeit Ozempic. The agency urges wholesalers, retail pharmacies, healthcare practitioners, and patients to thoroughly inspect the products they have received. It advises against distributing, using, or selling any products labeled with lot number NAR0074 and serial number 430834149057. Despite these efforts, the FDA warns that some counterfeit products may still be present in the market.
Apart from potential dangers arising from the imitation drugs, there is an additional risk associated with the needles used in these counterfeit products. As the needles themselves are counterfeit, their sterility cannot be confirmed, thus increasing the chances of infection for individuals who use these fraudulent Ozempic products.
Upon analysis, the FDA has found several confirmed counterfeit components within the seized items, including the pen label, accompanying health care professional and patient information, and carton. To address the issue of counterfeit products effectively, Novo Nordisk released guidelines on how to differentiate between authentic and fake Ozempic.
Authentic Ozempic pens do not extend or increase in length when the dose is being set. Additionally, the genuine dose dial window only displays the intended doses:
– The pen for 0.25/0.5 mg doses shows -0-, 0.25, and 0.5 when dialed up to the appropriate doses.
– The pen for 1 mg doses shows -0- and 1 mg once dialed up to the intended dose.
– The pen for 2 mg doses shows -0- and 2 mg once dialed up to the desired dose.
Currently, authentic Ozempic pens are available in three configurations: 0.25/0.5 mg pen, 1 mg pen, and 2 mg pen. The authentic Ozempic box includes four needles that directly attach to the pen, except for the 0.25/0.5 mg dose carton, which contains six needles.
To identify a counterfeit pen, individuals should note if the scale extends outward from the pen when setting the dose. Counterfeit pens may also possess labels of poor quality that do not adhere well to the pen. Additionally, counterfeit cartons may display spelling errors on the front (e.g., ‘1 pen and 4 doses’ without space between ‘1’ and ‘pen’) and could lack tamper-resistant measures. The batch number printed on counterfeit boxes may not correspond to the stated product strength on the same box and pen.
Novo Nordisk had previously alerted the public to fake Ozempic in August. The counterfeit product was found to contain a different type of diabetes medication, resulting in adverse reactions among those who unknowingly consumed it.
While the FDA has noted five adverse events from the counterfeit Ozempic lot, these incidents have not been severe and align with common reactions to genuine Ozempic, including nausea, vomiting, diarrhea, abdominal pain, and constipation.
With the FDA’s recent warning and Novo Nordisk’s guidance, it is crucial for individuals and entities within the healthcare system to exercise caution and remain vigilant about the authenticity of Ozempic products. By following these measures, the risks associated with counterfeit drugs can be mitigated, ensuring the safety and well-being of consumers nationwide.
