Last Updated on December 28, 2023 by admin
Counterfeit versions of Ozempic, a widely used diabetes medication often prescribed for weight loss, have raised concerns among health regulators globally. This fraudulent drug has surfaced in more than a dozen countries, sparking alarm not only in the United States but also drawing attention from the World Health Organization (WHO).
Timothy Mackey, a global health professor at the University of California, San Diego, specializing in counterfeit drugs, emphasized the popularity of Ozempic and the consequent risk it poses. Regulatory bodies worldwide are actively working to curb the circulation of these counterfeit medications due to the vulnerability of people worldwide to such fakes.
The WHO’s Member State Mechanism on Substandard and Falsified Medical Products recently discussed the issue of counterfeit semaglutide products, the active ingredient in Ozempic. According to WHO spokesperson Daniel Epstein, member countries were urged to take necessary measures in response to this recognized threat.
In the United States, the Food and Drug Administration (FDA) reported seizing thousands of counterfeit units of the drug. Collaborating with Novo Nordisk, the drug’s patent holder, the FDA initiated testing on the seized counterfeit drugs to ascertain their composition. Investigations revealed that the accompanying needles in the counterfeit injectable medication were not sterile. Additionally, the labeling, packaging, and prescription information were falsified.
Although no serious injuries related to counterfeit medications have been reported to date, the FDA acknowledged five adverse events, all aligning with known side effects of authentic Ozempic, such as nausea, vomiting, and diarrhea.
In Europe, the European Medicines Agency (EMA) disclosed the discovery of fake Ozempic at wholesalers in the European Union and the United Kingdom. The counterfeit pens, labeled in German, were identified through inactive serial numbers on the packages. Austrian regulatory authorities revealed instances where individuals were hospitalized due to serious side effects, hinting that the fake products contained insulin instead of semaglutide.
The connection between the counterfeit Ozempic in the U.S. supply chain and those found in other countries remains unclear, raising questions regarding their origins and distribution pathways.
Both the FDA and Novo Nordisk declined to provide further comments beyond their previous statements, citing ongoing investigations into the matter.
Novo Nordisk stated that the seizure of counterfeit drugs occurred outside their authorized supply chain. Meanwhile, the Partnership for Safe Medicines, a nonprofit coalition overseeing supply chain producers and distributors, has been actively monitoring cases involving counterfeit Ozempic and similar weight-loss drugs across multiple nations.
Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, highlighted that while these fake products may not be exact replicas, they closely resemble the authentic drug, making it challenging to discern their fraudulent nature. This resemblance complicates efforts to detect and prevent the circulation of these counterfeit medications.
This article was originally published on NBCNews.com