Canadians are being advised to stop using health products and veterinary drugs containing gentian violet, an antiseptic dye used to treat fungal infections.
Following a safety review, Health Canada concluded that exposure to these products could increase a person’s risk of cancer. It said there’s no safe amount of these products, and therefore any exposure is a potential risk.
Products with gentian violet are used on the skin, mucous membranes, open wounds, as well as the nipple of nursing mothers in order to treat oral thrush in babies.
Licensed drug products with gentian violet have been taken from the market.
Health Canada confirmed that all product licences for non-prescription and veterinary drugs that contain gentian violet have been cancelled. It said the only non-prescription drug on the Canadian market that contained gentian violet was not expected to be on the market when the licence was cancelled, so a recall wasn't required. All veterinary drug products that contain gentian violet on the market have been recalled.
Health Canada said there are three licensed medical devices on the market that contain gentian violet, which are all sterile dressings made of polyurethane foam manufactured by Hydrofera. A risk assessment found that with these dressings it’s unlikely gentian violet will come into direct contact with the skin, so for most people it doesn’t pose an increased risk of cancer when used according to the manufacturer's instructions. Health Canada has requested that Hydrofera update the product labels to say that it should not be used for longer than six months, and it shouldn’t be used by pregnant or nursing women.
All human health products containing gentian violet should be returned to the pharmacy. Health Canada recommends animal owners discuss with veterinarians or pharmacies about how to safely dispose of any of the veterinary drugs.
Health Canada also says pregnant or nursing woman should not use any dressings containing gentian violet, and others should not use them longer than six months. Canadians are advised to speak to health-care professionals if they have any concerns, read product labels to verify they’ve been authorized for sale, report any issues to Health Canada, and to contact 1-800-267-9675 or complete an online complaint form if a drug with gentian violet is found in the marketplace.