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Compounded Sclerosants Not Approved by FDA May Cause Health Issues

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Sclerotherapy, or the injection of a sclerosant into a vein in order to close it and make it dissolve, is an effective way to treat spider and varicose veins. However, not all sclerosants are created equal.

There are two excellent FDA-approved sclerosants, Sotradecol and Asclera.  However, you should be aware that many physicians purchase compounded versions of these sclerosants. These compounded medications have not been subjected to FDA testing to determine safety and effectiveness, and the compounding pharmacies  are not regulated by the FDA.  Furthermore, studies have shown that these compounded sclerosants may be either stronger or weaker than labeled. The variability in potency could cause health issues for patients who end up receiving either much less of the drug or much more than indicated.

While there can be legitimate reasons to have a special medication compounded, in this case it is likely the main reason these compounded versions are used rather than an FDA-approved version is because they are much cheaper.

When considering sclerotherapy for spider or varicose veins, it’s important for both you and your phlebologist (vein physician) to be knowledgeable about what sclerosant is being used. Be sure to ask your physician if they are using FDA-approved sclerosants such as Sotradecol or Asclera rather than compounded agents.

As the weather heats up and Austinites start shedding their jackets for shorts and swimsuits, you might consider sclerotherapy as a way to erase varicose or spider veins. However, it is important to remember that not all sclerotherapy treatments were created equal.

The most commonly used sclerosant used today is FDA-approved Sotradecol. Sotradecol works by causing irritation on the inside of the vein so that the vein closes and dissolves. Sclerotherapy with Sotradecol is generally quick and not very painful. Asclera, another sclerosant offered by Dr. Zimmet, acts in the same way. The medication, which was originally meant to be an anesthetic, was approved by the FDA in 2010 and has since grown in popularity in the US.  Asclera (polidocanol) has been available in Europe since the 1960s, but required studies were only recently submitted to and approved by the FDA.

Some doctors, however, still use a hypertonic saline as a sclerosant, through which the vein is sealed due to dehydration. Unfortunately, this method of vein treatment irritates nerve endings due to its high sodium content and is thus quite painful. Virtually all patients find sclerotherapy with Sotradecol or Asclera significantly less painful than hypertonic saline. Sarah Wexler, an Allure magazine writer who tried Asclera, reported experiencing much less pain using Asclera, as well as minimal bruising.

Sclerotherapy can be a great way to boost confidence in your body, especially with summer on the horizon. Go to a physician who is very experienced and knowledgeable about sclerotherapy.

Benefits of Sotradecol and Asclera:

  • Minimal pain
  • Proven efficacy
  • Excellent safety profile

Problems with hypertonic saline sclerosant:

  • Intense burning during procedure
  • Possibility of skin ulceration

Photo: Oneras

About 1 in 3 adult Americans have some form of leg vein disease. Although these may be of just cosmetic concern, many people suffer significant symptoms that impact their daily quality of life. Even many physicians are unaware of the impact of leg vein disease on a person’s quality of life. Here are some warning signs of lower leg venous insufficiency.

Tired, achy, and/or heavy-feeling legs.

Leg pain from prolonged sitting or standing.

Leg discomfort improved with leg elevation.

Leg itching.

Night cramps.

Swollen ankles at night.

Restless legs.

Varicose or spider veins.

Discoloration of the lower leg.

Open sores or ulcers on lower leg.

History of vein problems in the family.

Consult a phlebologist, a vein disease specialist, if you are concerned about leg vein disease.

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