Ozempic maker says unapproved compounded drugs being sold in Canada

Unapproved, compounded versions of a celebrated glucosuria and weight-loss supplier are being sold successful Canada, nan Ozempic shaper said, amid a informing astir dosing errors that person resulted successful immoderate group being hospitalized successful nan United States.

Novo Nordisk told Global News connected Monday that it has revenge a title pinch Health Canada regarding nan promotion and waste of compounded semaglutide – which is simply a cardinal constituent successful some Ozempic and Wegovy – successful Canada.

“We are alert that respective compounding pharmacies, weight nonaccomplishment clinics, and aesculapian spas are purporting to waste aliases connection unapproved compounded semaglutide products some successful Canada and nan U.S.,” a spokesperson for Novo Nordisk Canada said successful an emailed statement.

“Patients should beryllium alert that Novo Nordisk is nan only institution successful Canada pinch Health Canada-approved products containing semaglutide and nan only institution successful nan U.S. pinch FDA-approved products containing semaglutide, identified nether nan waste and acquisition names Ozempic, Rybelsus and Wegovy.”

Compounding is erstwhile pharmacies aliases different practitioners person nan substances needed to operation and hole specialty medications, and do so. It was often utilized successful Canada by pharmacies during nan COVID-19 pandemic erstwhile manufactured supplies of children’s symptom medications were successful short supply, but nan pharmaceutical components to operation those medications were still disposable successful immoderate pharmacies.

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

On Friday, nan 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.

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

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

The Novo Nordisk spokesperson said nan FDA alert does not subordinate to nan company’s products, Ozempic aliases Wegovy, but pertains to compounded semaglutide products, which are not approved successful Canada nor successful nan U.S.

Novo Nordisk has revenge 21 lawsuits successful nan U.S. against aesculapian spas, weight-loss clinics and compounding pharmacies engaging successful “unlawful” trading and income of compounded narcotics claiming to incorporate semaglutide, nan spokesperson said.

Global News reached retired to Health Canada astir nan FDA informing and nan dosing errors, but did not person a consequence by nan clip of publication.

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

Semaglutide, nan cardinal constituent successful Wegovy and Ozempic, belongs to nan GLP-1 people of drugs, which activity by helping power humor sweetener levels and triggering a emotion of fullness.

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The FDA flagged nan higher consequence to patients from nan usage of compounded drugs, which whitethorn incorporate further ingredients, and whitethorn lend to imaginable medicine errors. Compounded narcotics are not assessed by nan FDA for safety, effectiveness aliases quality, nan regulator said.

“Compounded narcotics should only beryllium utilized to meet a patient’s needs if nan patient’s aesculapian needs cannot beryllium met by an disposable FDA-approved drug,” nan FDA said.

It urged health-care providers and compounders to supply nan due syringe size and counsel patients connected really to measurement nan dose.

Novo Nordisk’s Wegovy is disposable arsenic single-dose pre-filled pens that present a preset dose for once-weekly dosing, while Ozempic is disposable arsenic multiple-dose pre-filled pens for single-patient use, designed for once-weekly dosing.

In caller years, Canada, for illustration different countries, has seen a precocious request for medications for illustration Ozempic, which is chiefly approved for nan curen of Type 2 glucosuria but has been utilized off-label for weight loss.

Wegovy, an on-label weight nonaccomplishment medicine containing nan aforesaid supplier arsenic Ozempic but astatine a higher formulation and made by nan aforesaid manufacturer, also precocious became disposable to Canadians.

The World Health Organization (WHO) warned past month astir clone batches of Ozempic detected successful immoderate countries.

Health Canada told Global News successful June that location had been nary reports aliases complaints of counterfeit Ozempic successful nan country.

— pinch files from Reuters.