Efficacy, Purity of Compounded Sclerosant Questionable

Impurities in compounded STS make pharmaceutical version preferable, researchers report

TUESDAY, Sept. 25 (HealthDay News) -- Sodium tetradecyl sulfate (STS), a chemical used in venous sclerotherapy, is more likely to be free of impurities and possibly more effective in the FDA-approved, pharmaceutical-grade form (Sotradecol) than in compounded form, according to research published in the September issue of Dermatologic Surgery.

Jose I. Almeida, M.D., and Jeffrey K. Raines, Ph.D., of the University of Miami Miller School of Medicine in Florida, conducted a two-part study. In the first part, they compared the purity of Sotradecol, sold by AngioDynamics, with samples of compounded STS. In the second phase, they treated 51 veins in 37 adults with incompetent great saphenous veins with either 3-percent compounded STS or Sotradecol.

The researchers found no impurities in Sotradecol, but identified a variety of impurities in the compounded samples, including carbitol, which can cause dermatitis and hypersensitivity in humans. In the clinical portion of the study, the investigators found that compounded STS was significantly associated with more segments of incomplete ablation, which are thought to be indicative of increased long-term recanalization.

"When product quality, efficacy and liability are carefully considered, we are left with the conclusion that it would behoove physicians to use pharmaceutical-grade, FDA-approved sclerosant when treating their patients," the authors write.

This study was funded by AngioDynamics, the vendor of Sotradecol.

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