Cosmetic disfigurement from black salve
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COMMENTARY
Cosmetic disfigurement from black salve Lopa Thambi1 · Karen Konkel1 · Ida‑Lina Diak1 · Melissa Reyes1 · Lynda McCulley1 Published online: 26 September 2020 © This is a U.S. government work and its text is not subject to copyright protection in the United States; however, its text may be subject to foreign copyright protection 2020
Black salve is an indiscriminate escharotic, usually applied topically, that typically combines the corrosive compounds bloodroot (Sanguinaria canadensis) and zinc chloride. Topical formulations of black salve are sold over the counter under various commercial names other than black salve [1]. While not approved by the US FDA, black salve is advertised by marketers as safe and effective in the treatment of cancer, boils, bug bites, warts, moles, and skin tags. It allegedly targets diseased cells, leaving healthy tissue unharmed [1, 2]. Some homeopathic products include S. canadensis and zinc chloride or list them as inactive ingredients. However, these agents are corrosive, and FDA defines inactive ingredients as a “harmless drug that is ordinarily used as an inactive ingredient” (e.g., coloring, excipient) [3]. In the 1930s, Dr. Frederic Mohs combined S. canadensis with zinc chloride and antimony trisulfide, creating a fixative paste to prepare a skin cancer for surgical excision [2]. Mohs later decried using escharotics alone because of the risk of disfigurement and unreliability of cure [4]. Mohs’ technique evolved, seeing the paste replaced with sequential fresh frozen tissue sampling until margins are tumor free [5]. Mohs’ micrographic surgery, a single-day tissue-preserving procedure, is now the standard of care for high-risk, locally invasive skin cancers. Unfortunately, Mohs’ original work may be conflated with the modern surgical technique, leading to a misperception that black salve is a legitimate skin cancer treatment [6]. We received a case in the FDA Adverse Event Reporting System (FAERS) database describing cosmetic disfigurement with black salve. A 50-year-old female self-treated a Disclaimer: The views expressed are those of the authors and not necessarily those of the US Food and Drug Administration. * Karen Konkel [email protected] 1
Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
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skin lesion on her nose with a topical black salve product, which she purchased online after researching the product and perceiving it to be safe. For 6 days, she applied the product to the lesion, along with petrolatum and an occlusive dressing. Upon noticing an erosion, she contacted the company selling the product, which informed her the product was working as expected. She then consulted a plastic surgeon, who advised her that surgical intervention was not feasible because of the “thin skin” on her nose. The eroded area was treated with azithromycin, bacitracin, and triamcinolone. Unfortun
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