Improper Potency and Impurities in Compounded Polidocanol
Mann, M.; Munavalli, G.S..; Amatangelo, L.; Morrison, N.
Journal of Drugs in Dermatology Jdd 18(11): 1124-1127
2019
ISSN/ISBN: 1545-9616 PMID: 31741355 Document Number: 17978
Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy.
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