Health Canada recalls semaglutide drugs made by compounding pharmacy

Health Canada is recalling compounded drugs containing semaglutide, which is simply a cardinal constituent successful fashionable medications similar Ozempic and Wegovy.

The drugs were compounded by Alberta-based Create Compounding Pharmacy and comprised semaglutide, which belongs to the GLP-1 people of drugs, and pyridoxine, which is simply a signifier of vitamin B6.

“The merchandise was produced with an unauthorized progressive pharmaceutical ingredient,” Health Canada said successful the callback published Tuesday.

The drugs were sold successful syringe oregon vial form.

Compounding is erstwhile pharmacies oregon different practitioners person the substances needed to premix and hole specialty medications, and bash so. It was often utilized successful Canada by pharmacies during the COVID-19 pandemic erstwhile manufactured supplies of children’s symptom medications were successful abbreviated proviso but the pharmaceutical components to premix those medications were inactive disposable successful immoderate pharmacies.

It is lone meant to beryllium done successful cases wherever determination is constricted proviso of a medicine “and should not beryllium done solely for economical reasons for the healthcare professionals,” according to Health Canada guidelines connected compounding.

Ozempic shaper Novo Nordisk says it’s the lone institution successful Canada with Health Canada-approved products containing semaglutide.

Novo Nordisk told Global News past summer that it had filed a ailment with Health Canada regarding the promotion and merchantability of compounded semaglutide.

“We are alert that respective compounding pharmacies, value nonaccomplishment clinics, and aesculapian spas are purporting to merchantability oregon connection unapproved compounded semaglutide products some successful Canada and the U.S.,” a spokesperson for Novo Nordisk Canada said successful an emailed connection successful July 2024.

Health Canada is advising patients to consult their doc earlier stopping the usage of the recalled drugs oregon for immoderate wellness concerns.

Consumers should besides interaction the institution if they person immoderate questions astir the recall, the bureau said.

Any broadside effects tin beryllium reported to Health Canada.

Last year, the U.S. Food and Drug Administration (FDA) issued an alert informing doctors and patients astir dosing errors involving compounded semaglutide injectable products that were dispensed successful multiple-dose vials.

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The wellness regulator said it had received reports of adverse events, with immoderate requiring hospitalization, that whitethorn beryllium related to overdoses owed to patients incorrectly self-administering the compounded cause and health-care providers miscalculating doses.

Because of the dosing errors, patients mistakenly took 5 to 20 times much than the intended dose, the FDA said.

The Novo Nordisk spokesperson told Global News astatine the clip that the FDA alert does not subordinate to the company’s products, Ozempic oregon Wegovy, but pertains to compounded semaglutide products, which are not approved successful Canada nor the U.S.

Among the adverse events reported successful the U.S., immoderate patients experienced nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.

Semaglutide works by helping power humor sweetener levels and triggering a feeling of fullness.

In caller years, Canada, similar different countries, has seen a precocious request for medications similar Ozempic, which is chiefly approved for the attraction of Type 2 diabetes but has been utilized off-label for value loss.

Wegovy, an on-label value nonaccomplishment medicine containing the aforesaid cause arsenic Ozempic but astatine a higher formulation and made by the aforesaid manufacturer, also became disposable to Canadians past year.

–with files from Reuters