Pub. no 160256
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Pharmaceuticals and Biologics
This safety review evaluated the risk of hepatitis B virus (HBV) reactivation associated with direct-acting antivirals (DAAs): Daklinza (daclatasvir), Epclusa (sofosbuvir, velpatasvir), Galexos (simeprevir), Harvoni (sofosbuvir, ledipasvir), Holkira Pak (dasabuvir, paritaprevir, ombitasvir, ritonavir), Sovaldi (sofosbuvir), Sunvepra (asunaprevir), Technivie (paritaprevir, ombitasvir, ritonavir), and Zepatier (grazoprevir, elbasvir). Health Canada's review concluded that there may be a link between the risk of HBV reactivation in patients infected with both HBV and hepatitis C virus that have been treated with certain DAAs. Health Canada has recommended that the Canadian product monographs for all DAAs be updated to inform about this risk, as a precaution. Health Canada has also communicated this information to Canadians.
These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. The products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.
Health Canada is reviewing the safety of certain drugs used for general anesthesia and sedation in children under the age of three, or in pregnant women during their third trimester. This follows a recent communication by the U.S. Food and Drug Administration warning the public that repeated or lengthy use of general anesthetics and sedatives in these groups may have potential negative effects on the development of children’s brains. Health Canada will continue to update Canadians as the review is completed.
Health Canada advised Canadians that the unauthorized product “Control-Max” may pose serious health risks as it is labelled to contain yohimbine. The product was being sold online by the company RGR Canada Inc.
Health Canada advised Canadians that 3 unauthorized products, “Lithium Plus, Serotonin Support, and Brain Support,” may pose serious health risks because they may contain lithium orotate. The products were offered for sale online by the company Cutting Edge Naturals and were marketed to contain lithium orotate.