The U.S. Food and Drug Administration (FDA) has issued an alert warning healthcare providers and patients about significant dosing errors involving compounded semaglutide injectable products. These errors have resulted in patients receiving doses 5 to 20 times higher than intended. The alert affects multiple-dose vials of semaglutide, a key component in medications like Ozempic and Wegovy, popular for managing blood sugar levels and weight loss.
Following the FDA’s alert, Health Canada has initiated a recall of compounded drugs containing semaglutide, specifically those produced by Create Compounding Pharmacy in Alberta. These recalled drugs combined semaglutide with pyridoxine, a form of vitamin B6. Health Canada emphasized that these products were made using an unauthorized active pharmaceutical ingredient, which raises safety concerns.
"The product was produced with an unauthorized active pharmaceutical ingredient." – Health Canada
Semaglutide, belonging to the GLP-1 class of drugs, plays a crucial role in controlling blood sugar and promoting a feeling of fullness. While Novo Nordisk, the manufacturer of Ozempic, is the sole provider of Health Canada-approved semaglutide products in Canada, the FDA alert does not pertain to its products Ozempic or Wegovy. Wegovy, specifically used for weight management, became available to Canadians last year.
"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." – Novo Nordisk Canada
The compounded semaglutide products under recall have not received approval in either Canada or the United States. Health authorities are urging patients using these recalled drugs to consult their healthcare professionals before discontinuing use or if they have any health concerns related to the medication.
This incident underscores the critical importance of using authorized pharmaceutical ingredients and adhering to approved dosing guidelines to ensure patient safety. Health Canada and the FDA continue to monitor the situation closely and advise caution when dealing with unauthorized compounded medications.
