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FDA Approves New Varicose Vein Treatment

Asclera Approved to Treat Small Varicose Veins

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March 31, 2010 -- The FDA has approved a new and potentially less painful treatment option for varicose veins.

Yesterday, the FDA approved Asclera (polidocanol) for the treatment of small varicose veins.

Asclera is part of a class of drugs known as sclerosants that are injected into the affected veins and work by damaging the cell lining of blood vessels. The damaged blood vessels eventually close and are replaced by healthy tissue.

The drug’s manufacturer says Asclera also includes an anesthetic agent, which may make it less painful to use.

Researchers say up to 50% of women are affected by varicose veins. The abnormally swollen or twisted veins are often red or blue and look like red or blue tree branches or spider webs close to the surface of the skin.

“Varicose veins are a common condition,” Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research, says in a news release. “Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance.”

Varicose veins normally occur in the legs but may form in other parts of the body. Women are much more likely than men to develop varicose veins. Other factors that increase the risk of developing varicose veins include older age, pregnancy, obesity, and standing for prolonged periods of time.

Asclera has been approved to treat spider veins (small varicose veins less than 1 millimeter in diameter) and reticular veins (varicose veins that are 1 to 3 millimeters in diameter).

In its approval of Asclera, the FDA noted that common adverse reactions to the drug include leakage and collection of blood from damaged blood vessels at the injection site (known in medical terms as a hematoma), bruising, irritation, discoloration, and pain at the injection site.

Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany. The drug has been available in Europe for more than 40 years under the name Aethoxysklerol.

WebMD Health News Reviewed by Laura J. Martin, MD on March 24, 2010



News release, FDA.

News release, Bioform Medical.

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