FDA Approves Polidocanol for the Treatment of Small Varicose Veins

Emma Hitt, PhD

March 31, 2010

March 31, 2010 — The US Food and Drug Administration (FDA) has approved polidocanol injection (Asclera, Chemische Fabrik Kreussler & Co) for the treatment of small varicose veins.

Specifically, polidocanol is approved to close spider veins (<1 mm in diameter) and reticular veins (1 - 3 mm in diameter), according to the FDA press release issued on Monday.

"Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," noted Norman Stockbridge, MD, PhD, from the Center for Drug Evaluation and Research at the FDA, in the written release.

Polidocanol creates fibrosis within the cell lining of blood vessels, causing them to collapse; the vein is then eventually replaced by other types of tissue.

Adverse reactions to polidocanol include leakage, hematoma, bruising, irritation, discoloration, and pain at the injection site.

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