Health Canada warns Canadians of potential cancer risk associated with gentian violet

Health Canada has completed a safety review of human health products and veterinary drugs containing gentian violet and has found that exposure to these products may increase the risk of cancer. Given the seriousness of this risk, Health Canada is advising Canadians to stop using all human and veterinary drug products containing gentian violet.

Gentian violet is an antiseptic dye used to treat fungal infections. Products containing gentian violet have been used on the skin, on mucous membranes (inside the nose, mouth or vagina), on open wounds, or on the nipple of a nursing mother to treat oral thrush in infants.   

Health Canada's review was triggered by the World Health Organization's Codex Alimentarius Commission's recommendation on the potential risk of cancer associated with veterinary drug residues in foods, including gentian violet. Although the Commission's recommendations were specific to food residues, Health Canada reviewed the safety of human non-prescription drugs, veterinary drugs and medical devices containing gentian violet.

After completing two safety assessments, the Department concluded that, as with other known cancer causing substances, there is no safe level of these products, and therefore any exposure to these products is a potential cause for concern.

What Health Canada is doing

Health Canada worked with all manufacturers with licensed drug products containing gentian violet to remove them from the market. 

Veterinary Drugs:
In Canada, there were nine registered veterinary drug products containing gentian violet, four of which were available as of April 2019: Blu Kote Dr Naylors, Cristisol, Guard and Wound Spray, and Wound Clear Spray. These products were used to treat surface wounds and eye infections in food-producing and companion animals (e.g., cattle, poultry, horses, dogs, cats). All manufacturers have voluntarily stopped marketing these products, their product licenses have been cancelled, and any products that were on the Canadian market have been recalled.

Should the Department identify unauthorized health products containing gentian violet being sold in Canada, it will take appropriate and timely action to protect the health and safety of Canadians.