Polidocanol injection for treating varicose veins has been approved by the Food and Drug Administration, according to the agency.
Distributed by BioFarm Medical Inc. as Asclera, polidocanol is approved to treat small spider and reticular veins, specifically those ranging in size from less than 1 mm to up to 3 mm. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue.
"Varicose veins are a common condition. Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," said Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the FDA's Center for Drug Evaluation and Research, Silver Spring, Md.
It is estimated that as many as 55% of American women and 45% of American men have some form of vein problem, according to the U.S. Department of Health and Human Services. Varicose veins affect half of people age 50 years and older.
Asclera is manufactured by the German company Chemische Fabrik Kreussler & Co.
Common adverse reactions to polidocanol include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site, the FDA said.
Most commonly occurring in the legs, varicose veins are caused by a number of factors, including genetics, age, female gender, pregnancy, and obesity; prolonged periods of standing may increase the risk for varicose veins, according to the agency.
Polidocanol has been used to treat varicose veins in Europe for more than 40 years.