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Compounded Sclerosants Not Approved by FDA May Cause Health Issues

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.

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