Leucadia Pharmaceuticals is unveiling the only FDA-approved sodium tetradecyl sulfate (STS) generic.
STS is a sclerosing agent used to treat small varicose veins of the lower legs. It is AP rated, bar coded, and does not contain natural rubber latex. It is therapeutically equivalent to Sotradecol (Mylan Pharma Group Limited) and is a safe and effective alternative to the use of unapproved compounded products.
"For years patients have had no good options when seeking an affordable generic alternative to Sotradecol," said Dr. William Larkins, CEOof Leucadia Pharmaceuticals' parent company, Custopharm. "As a result, some have turned to compounding pharmacies. Instead of finding a lower cost product they have been met with a 'Wild West' of unapproved and unregulated options, which can present significant additional risk with no commensurate benefit."
Researchers led by Dr. Mitchel Goldman, president of the American College of Phlebology, found specific inconsistencies with STS products made through compounding. The study found some compounding pharmacies were producing 3% sodium tetradecyl sulfate by simple dilution of a 27% industrial detergent solution that is not manufactured for use in humans.
"Our investigation found troubling content variability in compounded STS solutions we studied," said Goldman. "These compounding pharmacies were using a lower-quality ingredient as a starting material, resulting in significant concentrations of a highly toxic contaminant called carbitol. Both patients and physicians need to be aware that the stated concentration of these compounded drugs may not be correct and that potentially harmful contaminants may be present in the solution. Leucadia's generic STS solves this problem by finally providing a regulated, FDA-approved alternative."
Source: Leucadia Pharmaceuticals, Dec. 11, 2019