Health Canada pulls all Gentiane Violet Liquid Topical from the market, warns Canadians of potential cancer risk associated with it

    Gentiane Violet Liquid Topical (gentian violet) is a non-prescription drug that has been used to treat infections of the skin (cutaneous) and inside the nose, mouth, and vagina (mucocutaneous). Gentian violet can also be found in Hydrofera Antibacterial Foam Dressings, which are used as external dressings for wounds.
    Health Canada conducted two health risk assessments on gentian violet-containing human therapeutic products: one on the non-prescription drug product and one on the medical devices (foam dressings). These assessments were 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.1
    Health Canada's risk assessment of the non-prescription drug product concluded that there is evidence based on animal studies in the scientific literature of a potential for a link between gentian violet and cancer. In studies, cases of cancer in animals following oral exposure of gentian violet were noted. There have been no reported cases of cancer in humans associated with the use of topical gentian violet in Canada or internationally.
    Health Canada notified the manufacturer of Gentiane Violet Liquid Topical of the results of the assessment. The manufacturer agreed to voluntarily discontinue marketing of their product in Canada and their health product drug licence has been cancelled.
    Health Canada's risk assessment of medical devices containing gentian violet concluded, based on the limited exposure to gentian violet, that the risk of cancer is unlikely. However, no clinical data to support the safety and effectiveness of the device for pregnant and nursing women has been provided, and as a precaution, Health Canada will work with the manufacturers to update the Instructions for Use to strengthen existing warnings.
    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.
    Following a separate risk assessment for veterinary drugs, manufacturers of these products also agreed to voluntarily discontinue marketing their products in Canada and their drug licence has been cancelled.

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

Starting date:

June 12, 2019

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-70179

Last updated: 2019-06-12

 

Issue

OTTAWA - 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 you should do

• Stop using all drug products that contain gentian violet, including on animals. Products for humans should be returned to a pharmacy for proper disposal. Animal owners can discuss options for the safe disposal of their products with their veterinarians or local pharmacies.
• Do not use dressings containing gentian violet for longer than six months or if you are pregnant or nursing.
• Consult your health care professional if you have used any health products containing gentian violet and have health concerns.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching the Drug Product Database, Medical Devices Active Licence Listing (MDALL) and Licensed Natural Health Product Database.
• Report any health product-related adverse reactions or complaints to Health Canada.
• Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a drug product that contains gentian violet in the Canadian marketplace.

Media enquiries

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

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

Human Non-prescription Drugs:

There was only one non-prescription drug product containing gentian violet marketed in Canada. Gentiane Violet Liquid Topical is an antiseptic used to treat infections of the skin and mucous membranes. This product is also known to be used by some nursing mothers to treat oral thrush in infants. The manufacturer has voluntarily stopped marketing this product in Canada and its product licence has been cancelled. The manufacturer indicated that the product was no longer available on the market, so no recall was required.

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 licences have been cancelled, and any products that were on the Canadian market have been recalled.

Medical Devices:

There are currently three licensed medical devices on the market that contain gentian violet. They are all sterile dressings made of polyurethane foam, and are used for wounds such as sores, skin graft sites, abrasions and cuts. They are all made by one manufacturer (Hydrofera). The risk assessment for these devices found that the gentian violet is unlikely to come into direct contact with the skin, therefore these products do not posean increased risk of cancer when used for a short time and in most people. The Department has requested that the manufacturer update the product labels to state that these products should not be used for longer than six months and should not be used by pregnant or nursing women as a precaution because of the lack of information available to support these uses.

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.