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Compounded Sclerosants Not Approved by FDA May Cause Health Issues

Tag Archives: varicose veins

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

Celebrities in their forties, fifties or sixties can spend thousands of dollars on over the counter creams and plastic surgery. No matter how much cosmetic work they’ve had done, there is one oft-neglected body part that almost always reveals their “true” age- their hands. Hands and lower arm veins become more visible with age, but are often overlooked by patients who are considering cosmetic dermatology procedures.

Ropey veins are more noticeable in middle-aged women who are in-shape and have slender frames since they have little fat to hide the vein’s appearance. Currently, there are three minimally invasive treatments designed to reduce and eliminate appearances of veins.

Sclerotherapy is the injection of a sclerosing agent (such as Sotradecol or Asclera) into the veins, causing them to shrink. This is my preferred method, as advantages include speed of treatment, ease of recovery and lower cost. Most patients see significant improvement in the appearance of their hand veins. It’s also easy to repeat treatment when needed. Disadvantages are that it may take 2-3 sessions to obtain maximal improvement. Allergic reactions and other side effects are possible but rare.

Endovenous laser treatment (EVLT), involves the insertion of a small laser fiber, usually through a needle stick in the skin under ultrasound visualization, into the vein. Pulses of laser light are delivered inside the vein, which causes the vein to collapse and seal shut. Blood flow is diverted to nearby veins, minimizing the vein appearance in hands. The procedure is done in-office under local anesthesia. Advantages of this approach are that treatment is generally effective with one treatment. Disadvantages include high cost, need for local anesthesia, increased risk of skin injury, and potential for longer recovery times. Also, veins to be treated with EVLT need to be relatively straight.

Ambulatory phlebectomy is the removal of veins, under local anesthesia, through small punctures in the skin. Advantages are that usually one treatment session is effective. Disadvantages are that it requires small incisions, local anesthesia, and compression bandages. Bruising is common.

Given that each patient condition varies, Dr. Zimmet begins by taking a medical history and performing a physical examination. While most patients with prominent hand veins can be treated safely, it’s important for the physician to rule out certain underlying conditions before embarking on treatment. Also, it’s important not to close all superficial hand/arm veins in case a need arises for intravenous lines.

When’s the last time you wore shorts or short skirts without feeling self-conscious? If you’re a woman between the ages of 40 and 50, you’ve noticed the increase of those pesky spider-like purple-bluish veins blemishing your legs. Over 50% of the population is affected by unsightly varicose or spider veins. Age is just one contributing factor to spider vein development. Hormonal factors, genetics, pregnancy, injuries, and prolonged standing still also contribute to this cosmetic condition.

Many Vitamin-K based creams and gels claim to remove spider or varicose veins, but researchers have shown that topical remedies are not effective at penetrating the skin’s surface. Which treatment options offer optimal, long-lasting results? Sclerotherapy is an effective, scientifically-proven procedure to eliminate a vein’s appearance. “The gold standard of spider vein treatment is sclerotherapy,” says Dr. Steven Zimmet, President of the American Board of Venous and Lymphatic Medicine, a non-profit group to provides certification to vein physicians in the US.

In sclerotherapy, a fine needle is inserted into the vein. A sclerosing agent is injected into the vein itself, causing the vein walls to shrink and collapse. Since veins vary in depth and thickness, the injection is customized according to each patient’s condition. Various sclerosants are used, including dextrose/saline, Sotradecol® and Asclera®. Dr. Zimmet does not recommend routine use of hypertonic saline as this causes significant burning. Performed in a doctor’s office, the outpatient procedure takes an average of 20 minutes and patients can resume normal activities the same day of treatment. According to The American Society of Plastic Surgeons, more than 572,863 sclerotherapy treatments were performed in 2010.

The procedure’s popularity may be due in part to its success rate. The Mayo Clinic for Medical Education and Research reports that sclerotherapy has an overall success rate of 50% to 80% in eliminating treated veins. Maximal clearing generally requires a few sessions, with results seen about one month after each treatment.

With spring and summer around the corner in Austin, it is an ideal time to start spider vein removal. Learn more about leg veins and sclerotherapy vein treatment at Dr. Zimmet’s website.

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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