The U.S. Food and Drug Administration (FDA) has issued an alert regarding counterfeit versions of Ozempic, a medication primarily prescribed for type 2 diabetes but increasingly utilized off-label for weight loss. This warning follows the detection of several counterfeit drug units that have entered the market beyond the approved distribution channels of Novo Nordisk, the manufacturer of Ozempic.

Details of the Counterfeit Products

According to reports from both the FDA and Novo Nordisk, “several hundred units” of Ozempic were found to be counterfeit. The FDA learned about these fraudulent products on April 3 and quickly took action, seizing the identified units by April 9.

Patients, healthcare providers, and pharmacies are advised to carefully inspect their Ozempic stock. The counterfeit products can be identified by their lot number, PAR0362, and serial numbers beginning with 51746517. While the lot number matches the authentic product, the serial numbers do not.

Adverse Events Linked to Counterfeit Ozempic

Novo Nordisk has reported six adverse events associated with this batch of medication, which included both authentic and counterfeit doses. Although the side effects mirror those expected from legitimate Ozempic use, specifics regarding the adverse effects have not been disclosed.

Previous Alerts and Ongoing Investigation

This recent warning is not the first concerning counterfeit Ozempic. Earlier in 2023, the FDA alerted the public about thousands of counterfeit doses that were discovered in circulation. A spokesperson from Novo Nordisk refrained from commenting on the origins of the current counterfeit products or their connection to previous alerts.

Dave Moore, Executive Vice President of Novo Nordisk’s U.S. Operations, emphasized the company’s commitment to addressing the rise of counterfeit Ozempic. “It is gravely concerning, and we do all we can to alert patients, healthcare professionals, wholesalers, and retail pharmacies, about counterfeit incidents when they arise,” said Moore.

Safety Precautions and Advice for Consumers

Novo Nordisk is currently conducting an investigation which includes chemical testing of the counterfeit units. The company warns that neither it nor the FDA can confirm the safety or quality of the counterfeit products, which may pose significant health risks to individuals using them.

Both Novo Nordisk and the FDA advise against using any Ozempic that carries the aforementioned lot and serial numbers. Retail pharmacies are urged to procure the drug only from authorized distributors to ensure the authenticity of the product.

Conclusion

This development highlights ongoing concerns regarding drug safety and authenticity in the pharmaceutical market. Patients and healthcare professionals are encouraged to remain vigilant and report any suspicious products to the relevant authorities.