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Health Canada Issues Recall for Compounded Drugs Containing Semaglutide
Health Canada has announced a recall of compounded medications that include semaglutide, an essential ingredient found in well-known products such as Ozempic and Wegovy.
These compounded drugs were prepared by Create Compounding Pharmacy from Alberta and consist of semaglutide—part of the GLP-1 drug class—and pyridoxine, a form of vitamin B6.
According to the recall notice released by Health Canada on Tuesday, “The product was produced with an unauthorized active pharmaceutical ingredient.”
These medications were available in both syringe and vial formats.
Compounding involves pharmacies mixing and preparing specialized drugs when there is a need. This practice became notably common in Canada amid the COVID-19 pandemic when there was a shortage of commercially manufactured medications for children, although some pharmaceutical components remained accessible in pharmacies.
As stated in the guidelines provided by Health Canada, compounding should be conducted only under circumstances where medication supply is limited and not merely for financial gain by healthcare professionals .
Novo Nordisk, the manufacturer of Ozempic, maintains that it is the sole provider in Canada of products containing Health Canada-approved semaglutide.
Health Concerns and Reporting
Novo Nordisk contacted Health Canada last summer to express concerns about the promotion and sale of compounded semaglutide products. A representative from the company stated, “We are aware that several compounding pharmacies, weight loss clinics, and medical spas are purporting to sell or offer unapproved compounded semaglutide products both in Canada and the U.S.”
Health Canada is urging patients to speak with their healthcare provider before discontinuing any use of the recalled medications or addressing any health concerns.
The agency also advises consumers to reach out to the manufacturer for further inquiries regarding the recall, and any adverse effects experienced should be reported to Health Canada.
In a similar vein, last year, the U.S. Food and Drug Administration (FDA) issued warnings to healthcare professionals and patients about risks associated with compounded semaglutide, highlighting concerns over dosing errors involving injectable products dispensed in multi-dose vials.
The FDA reported instances where some patients consumed five to twenty times their intended dose due to miscalculations by both medical providers and self-administration errors.
In the past, numerous adverse events related to compounded semaglutide were noted in the U.S., which included symptoms like nausea, vomiting, abdominal pain, fainting, headaches, migraine, dehydration, and more severe conditions like acute pancreatitis and gallstones.
Semaglutide is primarily used for managing blood sugar levels and helping patients feel satisfied after eating. The surge in demand for medications such as Ozempic in Canada mirrors trends seen in other countries, particularly as Ozempic has gained popularity for off-label use in weight loss, despite being officially approved for Type 2 diabetes treatment. Wegovy, another weight-loss drug containing semaglutide at a higher dose, also became accessible to Canadian consumers last year.
–with files from Reuters
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globalnews.ca