引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Canada: Summary Safety Review - Gentian violet-containing human health products - Assessing the potential risk of cancer (English only) |
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Health Canada announces that it conducted a health risk assessment on gentian violet-containing products focused on a non-prescription drug product (Gentiane Violet Liquid Topical). The assessment was triggered by the World Health Organization's Codex Alimentarius Commission recommending that regulatory authorities prevent exposure to gentian violet in food because of its potential to cause cancer.
Gentian violet has been used in health products for both humans and animals. In humans, gentian violet has been used to treat infections of the skin. In animals, gentian violet has been used topically for the treatment of surface wounds and eye infections.
Health Canada received 4 Canadian reports of adverse events associated with the use of gentian violet-containing drug products. The reported adverse events include localized skin reactions, pain, discomfort, and local discoloration. Of these 4 reports, 2 involve infants (2 months and 5 months of age). These reports confirm the use of gentian violet to treat oral thrush in infants. Health Canada also identified 50 international reports involving the use of a gentian violet-containing drug product from VigiBase, 4 of which were considered serious. While there have been no Canadian nor international reports of cancer associated with the human use of gentian violet, animal studies show a link between gentian violet and cancer when ingested. It is unknown if applying gentian violet to the skin (topical application) has the same cancer causing effect. Some evidence suggests health products containing gentian violet are being used in infants and breastfeeding mothers. As such, it is possible that when gentian violet is applied to the nipple of the breast and/or used to treat thrush, it may be ingested by infants.
Health Canada's risk assessment of the non-prescription drug product concluded that there is evidence in the scientific literature, based on animal studies, that there is a potential for gentian violet to cause cancer. Although no cases of cancer associated with the use of topical gentian violet were found, oral exposure of gentian violet has been shown in animal studies to cause cancer. Health Canada contacted the manufacturer and notified them of the results of the assessment noting the potential risk of cancer with the use of gentian violet-containing drug products. The manufacturer of Gentiane Violet Liquid Topical voluntarily discontinued the sale of the product in Canada in May 2019, and their heath product drug licence has been cancelled. Consumers are advised to stop using the product and return it to their local pharmacy for proper disposal.
Health Canada has also looked at veterinary drugs that contain gentian violet and manufacturers of the 9 impacted veterinary drug products have agreed to voluntarily discontinue marketing their products in Canada and their drug licence have been cancelled.
An information update will be published to give Canadians more details about this risk, what consumers should do, and further actions taken by Health Canada.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00224
In Hong Kong, there are 5 registered pharmaceutical products containing gentian violet (also known as methylrosanilinium chloride), namely Gentian Violet Soln 1% (HK-11284), Lai Pou Gentian Violet Soln 1% (HK-47229) and E Ho Gentian Violet Solution 1% (HK-49083) which are registered by Jean-Marie Pharmacal Co Ltd, Banitore Gentian Violet Solution 1% (HK-46371) which is registered by Hengan Pharmacare Co Ltd, and Onetar Gentian Violet Solution 1% (HK-58334) which is registered by Unifort (Asia Pacific) Co Limited. All products are for topical use in human. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to gentian violet. 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/Thursday, Jun 13, 2019
Issued at HKT 16:00
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