Three cases of severe hypoglycemia, which needed medical intervention, have been linked to suspected counterfeit versions of Novo Nordisk’s top-selling diabetes drug, Ozempic (semaglutide). This information comes from Reuters, who cited America’s Poison Centers, a representative body for 55 regional poison control centers in the U.S. They found that one regional poison control center detected all three incidences, and the FDA is now investigating these reports.
In 2023, America’s Poison Centers recorded 3,316 reports from patients taking Ozempic variants. This figure is more than twice the number of Ozempic-related reports in 2022, according to clinical managing director Kaitlyn Brown. Most complaints were mild, reporting known side effects of Ozempic such as vomiting. However, 66 people experienced hypoglycemia and most had taken brand-name Ozempic and sought hospital treatment.
Ozempic’s active ingredient, semaglutide, is a GLP-1 receptor agonist. It imitates the GLP-1 hormone, triggering the release of insulin to regulate blood glucose levels. Semaglutide was approved under the name Ozempic in December 2017 for type 1 diabetes treatment. The drug is also prescribed for chronic weight management, marketed as Wegovy.
Despite its approval in June 2021, Wegovy has been unable to satisfy the market demand due to supply and production issues. In response, Novo has promised to invest $6 billion to increase Wegovy’s production capacity. Nevertheless, the market’s demand has created opportunities for counterfeit and compounded Wegovy and Ozempic versions.
In June 2023, the FDA cautioned consumers about some clinics and pharmacies selling unofficial versions of Ozempic and Wegovy. These unofficial versions could contain altered ingredients affecting the drug’s effectiveness, quality, and safety. Counterfeit versions are unregulated, and their safety cannot be guaranteed. Consequently, Novo initiated multiple lawsuits against medical spas, wellness and weight loss clinics, and pharmacies accusing them of selling products containing semaglutide.
In December 2023, the FDA seized thousands of counterfeit Ozempic injections linked to at least five adverse events. These events were not severe. However, the FDA pointed out that the counterfeit injection needles’ sterility could not be ascertained, increasing potential risk to consumers.
