If Polidocanol in Not FDA Approved, How Can It Be Used in the U.S.?
Doctor Answers 17
Polidoconol is now FDA approved
Polidoconol is not FDA approved for us in the United States. it is an excellent product. I use both Asclera and Sotradecol in my practice.
Asclera (Piloocanol) was recently approverd for use in the US after a long patent fight. It was used frequently in the 60's and 70's (80's?) by many vascular surgeons but there was a disagreement about-wait for it- money and it was taken off the market. it was "smuggled" in by vascular surgeons for subcutaneous injection of spider telangiectasia and reticular veins for years from both Mexico and Europe as it was significantly more effective than either Sodium morrhuate or Sodium Tetradecol in many surgeons' opinions.
I have found it to be useful but it works better in combination with other therapy such as IR/RF laser. Hopet his helps.
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Asclera (Polidocanol) is FDA approved in the US. In my experience, it works better than any of the other sclerosing agents available in the US market, and is much more comfortable.
Asclera - FDA Approved for spider veins and reticular veins
Asclera was FDA approved in the Spring of 2010 in two concentrations. The 0.5% solution is used to treat spider veins while the 1% is used to treat reticular veins, small (1-3 mm) blue veins on the legs. Polidocanol injections are well tolerated with a decrease incidence of pain, ulcerations, and post-sclerotherapy pigmentation.
FDA approved March 2010
I only used FDA-approved products in our practice and we welcome the FDA approval of polidocanol which may offer better comfort and decreased side effects including ulceration and dyspigmentation follownig sclerotherapy treatment.
Polidocanol is safe and is now FDA approved. It has a much lower side effect profile than sotradecol.
Polidocanol received FDA approval
in March 2010 and is called Asclera. Asclera has been my sclerosing agent of choice for several reasons: it comes in individually packaged ampules with expiration dates and lot numbers so there are no concerns about contamination, expiration and exact concentration. It has an long record of safety and efficacy as it has been used by physicians in Europe for many years. The chance of temporary post-inflammatory hyperpigmentation with Asclera is less than with other sclerosing agents, e.g. sotradechol.
Polidocanol for sclerotherapy
Polidocanol now (belatedly) FDA approved, and marketed by Bioform/Merz Pharmaceuticals. Excellent product.
Polidocanol for Leg Vein Injections
I have been using Polidocanol for leg vein injections for over 25 years because I feel that it is the best product out there for this treatment. It works as well as other Injectables, is virtually painless, and has a remarkable safety profile. It was finally approved for this use by the FDA in 2010.