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Safety Information

Trans-Tasman Early Warning System - Alert Communication

Black Salve - Buyer Beware

3 December 2013

Products affected
Information for consumers and caregivers
Information for healthcare professionals
Data summary
What action is Medsafe taking?
How to report
Further information

Black salve and related products are promoted as an alternative to conventional medicine for treating skin problems including skin cancer. These products work by ‘burning away’ (destroying) the skin (both healthy and potentially diseased) to form a thick black scab which eventually falls off. There is no scientific evidence that black salve and similar products are effective at treating disease/skin conditions.

A case of a severe necrotic lesion caused by black salve has been reported to the Centre for Adverse Reactions Monitoring (CARM). Consumers should be aware of the risks if they are considering using these unregulated products.

Products affected

These products are not regulated medicines in New Zealand. There is no monitoring of the quality, content or safety of these products.

Black salves generally contain zinc chloride (a pharmacy medicine when used on the skin) and/or the benzylisoquinoline alkaloid sanguinarine obtained from the bloodroot plant (Sanguinaria Canadensis).

These products may also be known as: red salves, yellow salves, Cansema, Can-X, Curaderm, Hoxsey’s dark red paste, bloodroot paste and Mexican black salve.

Information for consumers and caregivers

  • Black salve is an unregulated product. The quality of the product is unknown. 
  • There have been no clinical trials, so it is not known if these products work.
  • Black salve is an escharotic which means that it destroys the skin, (both healthy and diseased) to form a thick black scab which eventually falls off. This can be very painful and can take several weeks. It may also cause a disfiguring injury.
  • If you have any concerns about your skin (eg, moles freckles or rashes), speak to your healthcare professional.
  • Only a biopsy can tell you if a mole is cancerous or if skin cancer treatment has been successful.
  • Delaying medical treatment of suspicious moles increases the risk of the cancer spreading.
  • Black salve causes more skin damage (scarring) than conventional treatment. Some consumers have required extensive plastic surgery afterwards.
  • Report any adverse effects from medicines, including alternative medicines such as black salve to the Centre for Adverse Reactions Monitoring (see below).

 

Information for healthcare professionals

  • Black salves are available in New Zealand but are not regulated. Many products contain two escharotic agents: zinc chloride and the alkaloid sanguinarine obtained from Sanguinaria Canadensis (Bloodroot).
  • Use of Sanguinarine leads to the indiscriminate death of normal and cancerous cells and results in extensive tissue necrosis with possible secondary necrotising vasculitis.
  • Case reports in the literature indicate that some patients have residual cancer after black salve use. The effect in some patients can be severe for example complete loss of nasal ala (the side of the nostril).
  • The scarring that results from initial black salve treatment can obscure the tumour and disrupt the lesion continuity that is essential for optimal surgical performance (eg, excision).
  • Please report all suspected adverse reactions to medicines and alternative products to the Centre for Adverse Reactions Monitoring (see below).

Data summary

Eastman et al. 2013 have provided a comparison of black salve and conventional surgery.

Factor Black Salve Conventional Standard of Care
Success (no skin cancer recurrence) Unknown Nonmelanoma skin cancer
M: 67-99%, SE: 80-100%, EDC 92-98%
Melanoma
M: 67-99.5%, SE: 80-100%
Efficiency Days to weeks Complete in 1 day
Precise anatomic control Difficult Easy
Conservation of normal tissue Fair to poor Good to fair
Repair Delayed secondary intension M and SE immediate, primary closure
EDC delayed secondary intention
Cosmetic appearance Good to poor Good to fair
Evidence-based trials No Yes

M = Mohs micrographic surgery
SE = Surgical excision
EDC = Electrodessication and curettage

Summary of published case reports of effects in consumers using black salves.

Reference Cancer Biopsy Proven Outcome Residual Cancer?
Eastman et al. 2011 Unknown neoplasm on nose No Complete loss of left nasal ala Unknown
Osswald et al. 2005 BCC on nose Yes Defect healed by secondary intention Unknown
Brown et al. 2001 BCC on left cheek Yes Underwent three scar revisions No
SCC on right lower leg Yes Defect healed by secondary intention without complication No
McDaniel et al. 2002 BCC on right temple Yes Defect healed by secondary intention subsequent Mohs surgery to excise residual tumour Yes
BCC on right neck Yes Defect healed with triangular keloid scar underwent revision surgery No
BCCs on nose lip and cheek Yes Underwent Mohs surgery, partial maxillectomy; BCC metastasised to lymph nodes and bony sites Yes
Saltzberg et al. 2009 BCC on left nasal ala Yes Complete loss of left nasal ala Unknown
Jellnek et al. 2005 BCC on nose and scalp Yes Defect healed with scar over which the BCCs recurred, patient underwent Mohs surgery Yes
Laub 2008 BCC on nose, lip, cheek Yes Underwent Mohs surgery, partial maxillectomy, radical neck lymphadenopathy, radiation and chemotherapy. Developed multiple bony metastases and died Yes
Cienki et al. 2010 Malignant melanoma on chest Yes Referred to surgical oncology team Yes
Unknown subcutaneous abdominal nodules No Developed enterocutaneous fistulae, given bowel rest and discharged without complications Unknown
Affleck et al. 2007 BCC on nose Yes Fair cosmetic outcomes with depressed irregular scar on nasal tip Unknown

 

What action is Medsafe taking?

Medsafe investigates products that make therapeutic claims or contain scheduled ingredients that appear to be marketed in breach of the Medicines Act 1981.

How to report

Phone (03) 479-7247 to speak to a Medical Advisor at CARM
From your iPhone using the ADR online app
Online Submit an online report
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail (address is on the card)
Email carmnz@otago.ac.nz
Fax (03) 479-7150

 

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Further information

Further information is available from DermNet.

The TGA has issued an alert about these products.

The TGA has also published information about these products for consumers.

References

Eastman KL, McFarland LV, Raugi GJ. 2013. A review of topical corrosive Black Salve. Journal of Alternative and Complementary Medicine 18: DOI: 10.1089/acm.2012.0377.
Eastman K, McFarland L, Raugi G. 2011. Buyer beware: a black salve caution. Journal of the American Academy of Dermatology 65: e154.
Osswald SS, Elston DM, Farley MF, et al. 2005. Self-treatment of a basal cell carcinoma with "black and yellow salve". Journal of the American Academy of Dermatology 53: 509-511.
Brown CW, Goldstein GD, Birkby CS. 2001. Auto-mohs.com. Dermatologic Surgery 27: 975-978.
McDaniel S, Goldman GD. 2002. Consequences of using escharotic agents as primary treatment for nonmelanoma skin cancer. Archives of Dermatology 138: 1593-1596.
Saltzberg F, Barron G, Fenske N. 2009. Deforming self-treatment with herbal "black salve". Dermatological Surgery 35: 1152-1154.
Jellnek N, Maloney ME. 2005. Escharotic and other  botanical agents for the treatment of skin cancer: a review. Journal of the American Academy of Dermatology 53: 487-495.
Laub DR. 2008. Death from metastatic basal cell carcinoma: a herbal remedy or just unlucky. Journal of Plastic Reconstructive and Aesthetic Surgery 61: 846-848.
Cienki JJ, Zaret L. 2010. An internet misadventure: bloodroot salve toxicity. Journal of Alternative and Complemenary Medicine 16: 1125-1127.
Affleck AG, Varma S. 2007. A case of do-it-yourself Mohs' surgery using bloodroot obtained from the internet. British Journal of Dermatology 157: 1078-1079.

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