Polidocanol is not yet FDA approved, but it is the best

Robert Swanson, MD answers: IF Polidocanol in not FDA approved, how can it be used in the U.S.?

IF Polidocanol in not FDA approved, how can it be used in the U.S.?


Robert Swanson, MD
6 months ago

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 approval. Unlike the FDA approved agents, it does not hurt, it does not cause skin necrosis (local skin death) and when it extravasates (leaks out of the vein) it does not cause a tender lump under the necrotic skin.

Before I began to use Polidocanol I almost stopped performing sclerotherapy. The others are that bad, and Polidocanol is that good.

It does everything we could ask of a sclerotheraputic agent.

We can obtain it from Europe and use it here in the US, but it requires a lot of explanation to the patient. The patient has to trust the doctor.

 

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