FDA Approves Asclera for Treatment of Spider Veins
The U.S. Food and Drug Administration (FDA) announced its approval of Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins on Tuesday, March 30, 2010.
Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany.
The FDA has approved Asclera for the treatment of spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter). Asclera works by damaging the cell lining of blood vessels which closes the vessel.
Common adverse reactions to Asclera include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site.
Spider veins (telangiectatias) are similar to varicose veins, but they are smaller. It is estimated that up to 50% of women by age 50 will have spider veins veins. The difference between varicose and spider veins is one of size. The tortuous veins greater than 4-5 mm in diameter are referred to as varicose veins. The veins between 1-4 mm in diameter are referred to as reticular, and the veins less than 1 mm in diameter are referred to as spider veins. All three are the visible surface manifestations of an underlying venous insufficiency syndrome.
Spider veins, often red or blue, are closer to the surface of the skin than varicose veins. They can look like tree branches or spider webs with their short jagged lines. Spider veins can be found on the legs and face.
Factors such as genetics, age, female gender, pregnancy, obesity, and prolonged periods of standing may increase the risk for varicose veins. Activity is a strong protective factor against venous stasis.
Sclerotherapy, laser and intense-pulsed-light therapy, radiofrequency (RF) or laser ablation, and ambulatory phlebectomy are the modern techniques used to ablate varicosities.
Use of Asclera joins hypertonic saline, hypertonic glucose, sodium morrhuate, and sodium tetradecyl sulfate as an option for sclerotherapy of spider veins.
Sclerotherapy is the most common treatment for both spider veins. The injected vein fades over the weeks following injection. The same vein may need to be treated more than once. Most patients can expect a 50% to 90% improvement. Sclerotherapy does not require anesthesia, and can be done in the doctor's office.