Health Canada has issued a recall for compounded drugs containing semaglutide, a key ingredient in popular medications like Ozempic and Wegovy, due to safety concerns. These drugs, produced by Alberta-based Create Compounding Pharmacy, also contained pyridoxine (vitamin B6) and were sold in syringe or vial form.
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This move comes amid rising demand for semaglutide-based medications and concerns over unauthorized compounding practices.
Why the Recall Was Issued
The recall stems from the use of unauthorized active pharmaceutical ingredients in the compounding process. Compounding involves mixing pharmaceutical components to create custom medications, often in response to supply shortages.
Health Canada guidelines emphasize that compounding should only occur when there is limited availability of approved medications, not for economic gain by healthcare providers.
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Novo Nordisk’s Complaint Against Compounded Semaglutide
Semaglutide is a GLP-1 drug that helps regulate blood sugar levels and promotes feelings of fullness. It is the active ingredient in Ozempic and Wegovy, both manufactured by Novo Nordisk, the only company in Canada with Health Canada-approved semaglutide products.
Last year, Novo Nordisk raised concerns about unapproved compounded versions of semaglutide being sold by compounding pharmacies, weight loss clinics, and medical spas in Canada and the U.S.
What Patients Should Do
Health Canada advises patients using the recalled products to:
- Consult their doctor before discontinuing use.
- Reach out to Create Compounding Pharmacy for questions about the recall.
- Report any adverse side effects to Health Canada.
Compounded Semaglutide: Risks and Adverse Events
The U.S. Food and Drug Administration (FDA) has also warned about risks associated with compounded semaglutide products. Reports include dosing errors that caused some patients to take 5 to 20 times the intended dose, leading to severe health issues such as:
- Nausea, vomiting, and dehydration
- Acute pancreatitis
- Abdominal pain and gallstones
- Fainting and migraines
These compounded products are not approved by Health Canada or the FDA.
The Rising Demand for Semaglutide
Medications like Ozempic and Wegovy have grown increasingly popular, with Ozempic primarily approved for Type 2 diabetes and Wegovy for weight loss. Both have seen high demand in Canada, prompting some pharmacies to compound semaglutide to meet this need.
However, compounded versions are not subject to the same rigorous testing and approval processes, raising concerns about their safety and efficacy.
Looking Ahead: A Focus on Safety
The recall underscores the importance of using Health Canada-approved medications and highlights the risks of compounded drugs. Patients should remain cautious and consult healthcare providers for guidance on their medication choices.
This situation also raises broader questions about how to address rising demand for breakthrough medications like Ozempic and Wegovy while ensuring safety and compliance with regulatory standards.
Stay informed, stay safe, and prioritize approved treatments to protect your health.