Health Canada recalls compounded medications containing semaglutidewhich is a key component of popular medications like Ozempic And Wegovy.
The drugs were compounded by Alberta-based Create Compounding Pharmacy and included semaglutide, which belongs to the GLP-1 class of drugs, and pyridoxine, which is a form of vitamin B6.
“The product was manufactured with an unauthorized active pharmaceutical ingredient” » Health Canada said in the recall released Tuesday.
Medicines were sold in the form of syringes or vials.
Compounding occurs when pharmacies or other practitioners have and do the substances necessary to mix and prepare specialty medications. It was used frequently in Canada by pharmacies during the COVID-19 pandemic, when manufactured supplies of children’s painkillers were in short supply, but the pharmaceutical components for mixing these medications were still available in some pharmacies.
This is only intended in cases where the supply of medicines is limited “and should not be done solely for economic reasons for healthcare professionals”. according to Health Canada preparation guidelines.
Ozempic’s manufacturer, Novo Nordisk, says it is the only company in Canada with products containing semaglutide approved by Health Canada.
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Novo Nordisk told Global News last summer that she 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 claim to sell or offer unapproved compounded semaglutide products in Canada and the United States,” a Novo Nordisk Canada spokesperson said in a statement. press release sent by email in July 2024.
Health Canada advises patients to consult their doctor before stopping use of recalled medications 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 warn physicians and patients of dosing errors involving injectable semaglutide products dispensed in multiple-dose vials.
The health regulator said it had received reports of adverse reactions, some requiring hospitalization, which could be linked to overdoses due to patients incorrectly self-administering the compounded medicine and to healthcare providers who miscalculate doses.
Due to dosing errors, patients mistakenly took five to 20 times more than the intended dose, the FDA said.
Novo Nordisk’s spokesperson told Global News at the time that the FDA alert did not concern the company’s products, Ozempic or Wegovy, but concerned products containing semaglutide, which are not approved in either Canada or the United States.
Among adverse events reported in the United States, 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 high demand for drugs like Ozempic, which is primarily approved for the treatment of type 2 diabetes but has been used off-label for weight loss.
Wegovy, a weight loss drug on the label containing the same drug as Ozempic but in a higher formulation and made by the same manufacturer, also became available to Canadians last year.
–with files from Reuters
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