Vein Treatment: Q&A
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If Polidocanol in Not FDA Approved, How Can It Be Used in the U.S.?
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16 Doctor Answers |
Asked by
Paul Lea
in New Orleans,
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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.
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Asclera Approved
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...
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Los Angeles General Surgeon
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Asclera
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.
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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.
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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.
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Asclera
Polidocanol is safe and is now FDA approved. It has a much lower side effect profile than sotradecol.
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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...
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Polidocanol for sclerotherapy
Polidocanol now (belatedly) FDA approved, and marketed by Bioform/Merz Pharmaceuticals. Excellent product.
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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.
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Polidocanol FDA-approved March 30, 2010.
Polidocanol (Asclera--BioForm Medical, USA; Aethoxysclerol--Europe) is superior to all the other commonly-used sclerosants. It has been used with great success and excellent safety profile for many years in other countries, but until March 30, 2010, was not FDA-approved for any use in this country (USA). Though this drug has been around for many years, it was initially not approved by the FDA because it was developed as a new type of local anesthetic, but had the undesirable side effect of...
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Polidocanol-Now FDA approved
Polidicanol is now FDA approved. It causes less pain and has a lower incidence of allergic sensitivity than does Sotradecol. I have been pleased with the effectiveness of this product in my practice.
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Polidocanol vein injections with foam
Polidocanol is approved by the FDA in the United States. You can see the video of its use on youtube.
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Polidocanol works
Polidocanol is the best sclerosing agent available. It has minimal pain on injection and has an excellent saftey profile. I have treated hundreds of patients with this agent without complication. There is almost no risk of skin necrosis and ulceration with this agent. Unfortunately, it is not FDA approved in the United States for sclerotherapy. It can be used "off label" for this purpose.
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Polidocanol is not yet FDA approved, but it is the best
Polidocanol is not FDA approved, but it is the gold standard of sclerotheraputic agents. It is a safe and effective chemical that does what it is supposed to do.
In the past, I used 2 of the FDA approved agents, Tetradecyl Sulfate and Sodium Morrhuate. They are both painful and, in my view, dangerous. The reason they are FDA approved is that they have been around since the 1930's - before there was an FDA.
Polidocanol is widely used in Europe and the US. It is now being studied for FDA...
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Bay Area General Surgeon
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Polidocanol is not FDA approved for Sclerotherapy in the legs
Usually, questions like these are asked by pharmaceutical reps who sell other and competing sclerosing agents and want the word out that a certain drug is not FDA approved for competitive reasons.
There are different sclerosing agents that are FDA approved such as sodium morrhuate and sodium tetradecyl sulfate (STS). Hypertonic saline (HTS) is FDA approved but not as a sclerosing agent.
Once in the doctor's offfice, sclerosants can be used as "off label" if the patient gives...
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