Other safety alerts
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| Canada: Summary Safety Review: Valacyclovir-containing products: Assessing the potential risk of drug reaction with eosinophilia and systemic symptoms (DRESS) |
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Health Canada announces that it reviewed the potential risk of drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of valacyclovir-containing products. This safety review was triggered by updates made by the European Medicines Agency to the product safety information for valacyclovir-containing products to include the risk of DRESS.
DRESS is a rare, but serious, and potentially life-threatening drug reaction that includes fever, severe skin rash or peeling of the skin over large areas of the body, swollen face and high white blood cell count, affecting one or more organs. The symptoms of DRESS typically appear within 2 weeks to 2 months after starting a medication. DRESS is also known as drug rash with eosinophilia and systemic symptoms, drug induced hypersensitivity syndrome or DRESS syndrome.
Health Canada reviewed information provided by the manufacturer of the brand name product, and from searches of the Canada Vigilance database and the published literature. Health Canada reviewed 115 cases (3 Canadian, 112 international) of DRESS in patients taking valacyclovir. Of the 115 cases, 26 (international) met the criteria for further assessment to determine if there was a link between the use of valacyclovir and DRESS. Of the 26 case reports, 4 cases, including 3 published in the scientific literature, were found to be probably linked to the use of valacyclovir. Twenty-one cases, including 1 death, were found to be possibly linked, and 1 case was unlikely to be linked to the use of valacyclovir. In 25 of the 26 cases, patients were also taking other medications known to cause DRESS.
Health Canada's review of the available information concluded that there may be a link between the use of valacyclovir-containing products and the potential risk of DRESS. Health Canada will work with the manufacturers to update the Canadian product safety information for valacyclovir-containing products to include the risk of DRESS.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00284
In Hong Kong, there are 12 registered pharmaceutical products containing valacyclovir. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to valacyclovir. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, May 25, 2022
Issued at HKT 15:00
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