Black salve, red salve and cansema

Adverse reaction reports

Action taken by the TGA

About the TGA

What are black salve, red salve and cansema?

Black salve, red salve and cansema are products containing an active ingredient called sanguinarine, which comes from Bloodroot (Sanguinaria canadensis). Sometimes zinc chloride is also present.

These products have been sold in Australia as an alternative treatment for cancer, including skin cancer.

The TGA is advising consumers against purchasing or using black salve, red salve or cansema products.

Can these products treat cancer?

The TGA is not aware of any credible, scientific evidence that black salve, red salve or cansema can cure or treat cancer. In addition there is no evidence that these products can be used to diagnose cancers. In fact, the evidence shows that they will cause skin irritation regardless of whether any malignancy is present.

While some Internet sites contain testimonials supporting the use of these products, the TGA does not consider this to be adequate evidence to support their efficacy.

What do these products do?

Black and red salves and cansema are corrosive salves. They essentially burn off layers of the skin and surrounding normal tissue. They can destroy large parts of the skin and underlying tissue, and leave significant scarring.

What if I am seeking a new treatment?

If you are considering starting a new or alternative treatment for a serious condition or disease, such as cancer, the TGA strongly advises that you consult a medical practitioner first.

What if I have had an adverse reaction?

If you have used any black salve, red salve or cansema products and you are concerned about a possible adverse reaction, speak to a health professional.

Consumers and health professionals should report any adverse reactions associated with the use of any of these products to the TGA.

What adverse reactions have been notified to the TGA?

As at June 2012, the TGA has received four notifications of adverse events involving the use of products described as black salve, red salve or cansema.

Each of these reports describes damage to the skin, subcutaneous tissue and, in one case, muscle following the application of these products. Three of the reported cases required medical intervention or follow up and in two of the cases significant scarring resulted.

Has the TGA banned black salve, red salve and cansema?

The TGA has not banned these products because products with these names are not, and have never been, on the Australian Register of Therapeutic Goods (ARTG). All therapeutic goods supplied in Australia must be included in the Register unless exempted; these products have not been exempted. Inclusion in the ARTG is indicated on the product label by a number preceded by AUST R or AUST L.

It is part of the TGA's role to warn the Australian public of potentially harmful or ineffective therapeutic goods whether or not they are on the ARTG. The TGA released a safety alert via its Internet site on 19 March 2012 strongly advising consumers against purchasing or using any black salve, red salve or cansema products.

The TGA is investigating whether or not these products have been supplied unlawfully.

How does the TGA regulate therapeutic goods?

The role of the TGA is to apply the therapeutic goods legislation, primarily the Therapeutic Goods Act 1989.

All therapeutic products must be listed, registered or included in the ARTG before they can be supplied in Australia, unless otherwise approved under the therapeutic goods legislation.

What if a therapeutic good is not on the ARTG?

Therapeutic goods not on the ARTG have not been formally assessed to ensure that they meet the quality, safety and efficacy standards required under the legislation.

Unlawful importation or supply of therapeutic goods that are not entered on the ARTG or do not meet applicable standards carries penalties of up to $5.5 million.

How does the TGA regulate advertising of therapeutic products?

The Therapeutic Goods Advertising Code 2007 prohibits the use of representations regarding the treatment, cure or prevention of serious diseases - including cancer. The only exceptions to this are sunscreens and devices used in contraception or the prevention of transmission of disease between persons.

It is an offence under the Therapeutic Goods Act 1989 to include a prohibited representation in any advertising material.

Can I use black salve, red salve or cansema on animals?

The TGA does not regulate veterinary medicines.

The Australian Pesticides and Veterinary Medicines Authority issued a statement advising Australian consumers against purchasing the unregistered veterinary chemical product called 'Black Salve'.

Disclaimer

The TGA cannot give personal advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse reaction to a medicine.