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
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
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