FDA Approves New Varicose Vein Remedy

June 21, 2011

A new potentially less painful treatment method for varicose veins has been approved by the FDA.

Quite recently the FDA endorsed Asclera (polidocanol) drug for treatment small varicose veins. Asclera belongs to the class of drugs known as sclerosants that are injected into the affected veins and work by destroying the cell lining of blood vessels. The damaged blood vessels eventually regenerate and are covered by healthy tissue.

According to the drug’s manufacturer prescript, Asclera also comprises an anesthetic agent, which may make it less painful to administrate.

Researchers sustain that up to 50% of women suffers of varicose veins. The abnormally inflated or twisted veins are often red or blue and resemble tree branches or spider webs.

Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research, stated in a news release “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.”

In most cases varicose veins appear on legs, but may also affect and other parts of the body. Women are much more expose to varicose veins than men. The factors that may increase the risk of developing varicose veins are the following: obesity, pregnancy, older age and standing for prolonged periods of time.

Asclera has been authorized 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).

Among common adverse reactions to Asclera medication were registered leakage and collection of blood from damaged blood vessels at the injection spot (known in medical terms as a hematoma), irritation, bruising, discoloration, and pain at the injection site.

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