There have been recent reports of unapproved, compounded versions of the popular diabetes and weight-loss drug, Ozempic, being sold in Canada. Novo Nordisk, the maker of Ozempic, has filed a complaint with Health Canada regarding the promotion and sale of compounded semaglutide, which is a key ingredient in both Ozempic and Wegovy. Compounding involves mixing and preparing specialty medications when the manufactured supply is limited. The company has stated that patients should be aware that Novo Nordisk is the only company in Canada with Health Canada-approved products containing semaglutide.
Recently, the U.S. Food and Drug Administration (FDA) issued an alert warning about dosing errors involving compounded semaglutide injectable products that were dispensed in multiple-dose vials. Some patients incorrectly self-administered the compounded drug, resulting in dosing errors where patients took five to 20 times more than the intended dose. Novo Nordisk clarified that the FDA alert does not pertain to their products, Ozempic or Wegovy, but rather to compounded semaglutide products that are not approved in Canada or the U.S. The company has taken legal action against entities engaging in the unlawful marketing and sales of compounded drugs claiming to contain semaglutide.
The FDA warned about the higher risk associated with compounded drugs, as they may contain additional ingredients and contribute to potential medication errors. Compounded drugs are not assessed by the FDA for safety, effectiveness, or quality. Health-care providers and compounders are urged to provide the appropriate syringe size and educate patients on how to measure the dose. Novo Nordisk’s Wegovy is available as a single-dose pre-filled pen for once-weekly dosing, while Ozempic is available as a multiple-dose pre-filled pen for single-patient use.
In recent years, there has been a high demand for medications like Ozempic in Canada, primarily approved for Type 2 diabetes but used off-label for weight loss. Wegovy, a weight loss medication made by the same manufacturer as Ozempic, has also become available to Canadians. The World Health Organization (WHO) issued a warning about fake batches of Ozempic detected in some countries. Health Canada has stated that there have been no reports or complaints of counterfeit Ozempic in the country.
Overall, patients should be cautious of unapproved, compounded versions of medications like Ozempic and Wegovy being sold in Canada. Compounding can lead to dosing errors and risks associated with additional ingredients. It is essential to use FDA-approved medications from reputable sources to ensure safety, effectiveness, and quality. Patients should consult their healthcare providers before using any compounded drugs to ensure they meet their medical needs.
