Health Canada has issued a national recall for compounded medications that include semaglutide, an essential ingredient found in well-known weight-loss drugs such as Ozempic and Wegovy.
Semaglutide and pyridoxine were compounded by Create Compounding Pharmacy in Calgary and contain “an unauthorized active pharmaceutical ingredient,” Health Canada said in a Jan. 21 recall notice.
Pyridoxine is a variant of vitamin B6 while semaglutide mimics the GLP-1 hormone that is naturally produced in the human body. The hormone interacts with the brain to indicate feelings of fullness and is commonly used for the management of type 2 diabetes or as an anti-obesity treatment for long-term weight control.
The affected drugs were sold in both syringe and vial form.
Patients are advised by Health Canada to verify if their product is affected by the recall and to consult with their health-care provider prior to discontinuing the use of the recalled drugs.
The health agency is also encouraging consumers to contact the company if they have any questions or concerns about the recall and to contact Health Canada to report related side effects.
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Create Compounding Pharmacy has been operating in Calgary since 2018 and has expanded to other locations in Canada beginning with Toronto in 2021, followed by Vancouver in 2022, and Moncton, N.B., last year.
The chain of compounding pharmacies creates custom medications for both humans and animals, according to the company website. It compounds drugs for patients who need products that are not available commercially, when a product contains inactive ingredients a patient is sensitive to, or when a product is discontinued or on back-order.
Compounded drugs are custom-made medications that consist of a combination of two or more ingredients, resulting in a final formulation that is appropriate for dosing, according to Health Canada.
This practice is predominantly carried out by pharmacists or other health-care professionals who hold the necessary licences issued by the province or territory in which they operate.
Compounding is intended solely for situations where there is limited supply of a medication “and should not be done solely for economic reasons for the healthcare professionals,” Health Canada’s guidelines on compounding say.
US Warning on Compounded Semaglutide
The U.S. Food and Drug Administration (FDA) issued a warning last year directed at both doctors and patients about dosing inaccuracies associated with compounded semaglutide injectable products that were provided in multi-dose vials.
The U.S. health agency said patients requiring hospitalization had potentially been linked to overdoses resulting from improper self-administration of the compounded medication or errors in dosage calculations by health-care providers.
“The majority of the reports described patients mistakenly drawing up more than the prescribed dose from a multiple-dose vial during self-administration. In these instances, patients administered five to 20 times more than the intended dose of semaglutide,” the FDA said. “Most of the reports indicated that patients were unfamiliar with how to measure the intended dose using a syringe.”
Patients symptoms included nausea, vomiting, abdominal pain, dehydration, fainting, headache, migraine, acute pancreatitis, and gallstones.
There has been a marked increase in the demand in Canada and other countries in recent years for weight-loss drugs like Ozempic, which is the brand name for the drug semaglutide.
Novo Nordisk, the makers of Ozempic, introduced another weight-loss drug in Canada last May.
Wegovy arrived on the scene after extensive marketing of Ozempic and a social media-driven surge in demand for off-label use of that drug for weight loss. The weekly injection contains semaglutide at a higher dose and is approved for weight loss among patients diagnosed with obesity.
Experts say it’s critical that prescribers, including family doctors, ensure Wegovy is only given to patients who meet specific criteria such as having a body mass index that exceeds 30 kilograms per square metre or being overweight with a related medical condition like high blood pressure.
