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If Polidocanol in Not FDA Approved, How Can It Be Used in the U.S.?

Doctor Answers (16)

Polidoconol is now FDA approved

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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.
 


San Diego Dermatologic Surgeon
5.0 out of 5 stars 4 reviews

Asclera Approved

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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.

Jeffrey W. Kronson, MD
Los Angeles General Surgeon

Asclera

+1

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.

Jon M. Grazer, MD, MPH
Newport Beach Plastic Surgeon
5.0 out of 5 stars 4 reviews

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Asclera - FDA Approved for spider veins and reticular veins

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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.

Jennifer Peterson, MD
Houston Dermatologist
4.5 out of 5 stars 11 reviews

FDA approved March 2010

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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.

Melanie D. Palm, MD
San Diego Dermatologic Surgeon
5.0 out of 5 stars 12 reviews

Asclera

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Polidocanol is safe and is now FDA approved. It has a much lower side effect profile than sotradecol.

Timothy Mountcastle, MD
Ashburn General Surgeon
4.5 out of 5 stars 20 reviews

Polidocanol received FDA approval

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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.     

Felix Kuo, MD
Long Island Dermatologist
5.0 out of 5 stars 3 reviews

Polidocanol for sclerotherapy

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Polidocanol now (belatedly) FDA approved, and marketed by Bioform/Merz Pharmaceuticals.  Excellent product.

Steve Laverson, MD
San Diego Plastic Surgeon
5.0 out of 5 stars 38 reviews

Polidocanol for Leg Vein Injections

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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.

Mitchell Schwartz, MD
South Burlington Dermatologic Surgeon
5.0 out of 5 stars 8 reviews

Polidocanol FDA-approved March 30, 2010.

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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 causing the tiny capillaries in the injection area to seal shut. Not so good for a local anesthetic, but EXACTLY what you are looking for to treat spider veins--something that is otherwise minimally toxic which causes undesired spider veins to seal shut, and does so without pain! The previous FDA-approved sclerosants, sodium morrhuate and sodium tetradecyl sulfate, both cause severe or mild pain on injection, and have higher risk of other side effects compared to poildocanol. Doctors who used polidocanol prior to FDA approval purchased the pharmaceutical from manufacturers overseas, properly informed their patients, and have successfully used it for years.

As a side note, one of the most common sclerosants in the USA for years has been hypertonic saline, which is NOT FDA-approved for sclerotherapy either. This sclerosant had much more variability and potential for side effects since each physician who used it "off-label" used their own concentration, and some mixed it with other local anesthetics because hypertonic saline alone burned so painfully when injected into blood vessels.

Now that polidocanol is FDA-approved for the treatment of spider veins in the USA, you can expect that more physicians will be using it. There are still some side effects (bruising, hemosiderin staining, post-inflammatory hyperpigmentation, and occasional blister, ulceration, and/or scar) seen with ALL sclerosants (FDA-approved or not), but with skilled injector technique polidocanol is the GOLD STANDARD sclerotherapy agent.

Richard H. Tholen, MD, FACS
Minneapolis Plastic Surgeon
5.0 out of 5 stars 125 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.