Health Canada is recalling compounded drugs containing semaglutide, which is a key component in popular medications like Ozempic and Wegovy.
The drugs were compounded by Alberta-based Create Compounding Pharmacy and comprised semaglutide, which belongs to the GLP-1 class of drugs, and pyridoxine, which is a form of vitamin B6.
“The product was produced with an unauthorized active pharmaceutical ingredient,” Health Canada said in the recall published Tuesday.
The drugs were sold in syringe or vial form.
Compounding is when pharmacies or other practitioners have the substances needed to mix and prepare specialty medications, and do so. It was frequently used in Canada by pharmacies during the COVID-19 pandemic when manufactured supplies of children’s pain medications were in short supply but the pharmaceutical components to mix those medications were still available in some pharmacies.
It is only meant to be done in cases where there is limited supply of a medication “and should not be done solely for economic reasons for the healthcare professionals,” according to Health Canada guidelines on compounding.
Ozempic maker Novo Nordisk says it’s the only company in Canada with Health Canada-approved products containing semaglutide.
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Novo Nordisk told Global News last summer that it had filed a complaint with Health Canada regarding the promotion and sale of compounded semaglutide.
“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.,” a spokesperson for Novo Nordisk Canada said in an emailed statement in July 2024.
Health Canada is advising patients to consult their doctor before stopping the use of the recalled drugs or for any health concerns.
Consumers should also contact the company if they have any questions about the recall, the agency said.
Any side effects can be reported to Health Canada.
Last year, the U.S. Food and Drug Administration (FDA) issued an alert warning doctors and patients about dosing errors involving compounded semaglutide injectable products that were dispensed in multiple-dose vials.
The health regulator said it had received reports of adverse events, with some requiring hospitalization, that may be related to overdoses due to patients incorrectly self-administering the compounded drug and health-care providers miscalculating doses.
Because of the dosing errors, patients mistakenly took five to 20 times more than the intended dose, the FDA said.
The Novo Nordisk spokesperson told Global News at the time that the FDA alert does not relate to the company’s products, Ozempic or Wegovy, but pertains to compounded semaglutide products, which are not approved in Canada nor the U.S.
Among the adverse events reported in the U.S., some patients experienced nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
Semaglutide works by helping control blood sugar levels and triggering a feeling of fullness.
In recent years, Canada, like other countries, has seen a high demand for medications like Ozempic, which is primarily approved for the treatment of Type 2 diabetes but has been used off-label for weight loss.
Wegovy, an on-label weight loss medication containing the same drug as Ozempic but at a higher formulation and made by the same manufacturer, also became available to Canadians last year.
–with files from Reuters
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