Edathamil in the Treatment of Scleroderma and Calcinosis Cutis

Winder, Paul R.; Curtis, Arthur C.

doi:10.1001/archderm.1960.01580050074009

Cited by 18 publications

(6 citation statements)

References 12 publications

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“…(de Groot 1986). Winder and Curtis (1960) treated 19 patients for acrosclerosis with IV Disodium EDTA given over a 4-to 6-hour period. A majority of the patients received 2.5 to 3.0 g of Disodium EDTA in 500 cc 5% dextrose and water for 15 days.…”

Section: Case Reportsmentioning

confidence: 99%

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

2002

Int J Toxicol

108

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EDTA (ethylenediamine tetraacetic acid) and its salts are substituted diamines. HEDTA (hydroxyethyl ethylenediamine triacetic acid) and its trisodium salt are substituted amines. These ingredients function as chelating agents in cosmetic formulations. The typical concentration of use of EDTA is less than 2%, with the other salts in current use at even lower concentrations. The lowest dose reported to cause a toxic effect in animals was 750 mg/kg/day. These chelating agents are cytotoxic and weakly genotoxic, but not carcinogenic. Oral exposures to EDTA produced adverse reproductive and developmental effects in animals. Clinical tests reported no absorption of an EDTA salt through the skin. These ingredients are likely, however, to affect the passage of other chemicals into the skin because they will chelate calcium. Exposure to EDTA in most cosmetic formulations, therefore, would produce systemic exposure levels well below those seen to be toxic in oral dosing studies. Exposure to EDTA in cosmetic formulations that may be inhaled, however, was a concern. An exposure assessment done using conservative assumptions predicted that the maximum EDTA dose via inhalation of an aerosolized cosmetic formulation is below that shown to produce reproductive or developmental toxicity. Because of the potential to increase the penetration of other chemicals, formulators should continue to be aware of this when combining these ingredients with ingredients that previously have been determined to be safe, primarily because they were not significantly absorbed. Based on the available data, the Cosmetic Ingredient Review Expert Panel found that these ingredients are safe as used in cosmetic formulations.

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Section: Case Reportsmentioning

confidence: 99%

Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA

2002

Int J Toxicol

108

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“…Edathamil has been used to treat calcinosis with success. 2 adrenal steroids in calcinosis in a patient with scleroderma. Robertson et al 5 reported the efficacy of low-dose minocycline to control calcinosis in systemic sclerosis in 9 patients with limited systemic sclerosis, reducing the size of calcinosis deposits and decreasing the frequency of ulceration and inflammation associated with calcinosis.…”

Section: Discussionmentioning

confidence: 98%

Treatment of cutaneous calcinosis in CREST syndrome by extracorporeal shock wave lithotripsy

Sparsa¹,

Lesaux²,

Kessler³

et al. 2005

Journal of the American Academy of Dermatology

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“…The number of isolated cases reported that were treated empirically and no organized trial has highlighted the absence of an effective and codified treatment for CC. [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] The following agents have been prescribed: diltiazem, 11 aluminum hydroxide, 12 sodium thiosulfate, 13 colchicine, 14 edathamil, 15 intravenous immunoglobulins, 16 carbon-dioxide laser, 17 warfarin, 18 minocycline, 19 or bisphosphonates, 20-23 achieving variable efficacy and causing significant side effects. Excision of CC that are painful or a source of disability is sometimes proposed, but the topography (distal and periarticular site for SSC) and the extent of the lesions (CVI) can render surgical management difficult.…”

Section: Discussionmentioning

confidence: 99%