FDA Alerts Public to Counterfeit Ozempic and Associated Risks

FDA Alerts Public to Counterfeit Ozempic and Associated Risks

The U.S. Food and Drug Administration (FDA) has warned that there are fake versions of the diabetes drug Ozempic circulating. This warning follows their receipt of six reports of serious adverse events associated with one lot. The company’s reports consistently describe symptoms that align with common digestive problems associated with semaglutide, the active ingredient in Ozempic. This in particular has caused huge concern for public health officials. Crucially, none of these adverse events seem clearly linked to the counterfeit product per se.

On April 3, Novo Nordisk, the company that makes Ozempic, notified the FDA of a worrisome development. Their announcement provided details of how hundreds of units of counterfeit products had escaped the company’s legitimate supply chain. The disputed lot number PAR0362 is valid. So far, we have determined that any product with an SN beginning with 51746517 is a fake. Because these products are unlawful and unsafe for use, distribution, sale, or resale. This fake counterpart comes with substantial dangers. Because the sterility of the needles cannot be guaranteed, there is an increased risk of introducing infections.

To protect consumers, the FDA acted quickly by seizing the five counterfeit products on April 9. Additionally, they are partnering closely with Novo Nordisk to conduct tests on these seized products. Their aim is to authenticate, ensure quality and safety of the goods. Health care professionals, medical wholesalers, retail pharmacies and patients should check Ozempic boxes closely for lot number PAR0362. On top of this they need to be constantly on the lookout for the serial numbers.

Patients are urged to fill Ozempic only at state-licensed pharmacies and with a legitimate prescription. Before using the medication, they should verify the authenticity of the product to avoid potential health risks associated with counterfeit items. Those in possession of a counterfeit product should report it immediately to Novo Nordisk’s customer care at 800-727-6500, available Monday through Friday from 8:30 a.m. to 6:00 p.m. EST.

We applaud the FDA for taking this cautionary step. Specifically, it’s meant to protect patients from the threats posed by counterfeit medications. So the agency is watching the situation very closely. They are in daily contact with Novo Nordisk to address any new challenges that arise on this issue.

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Alex Lorel

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