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Doctors' Answers to "Frequently Asked Questions" - Off Label Use

These comments are made for the purpose of discussion and should NOT be used as recommendations for or against therapies or other treatments. An individual patient is always advised to consult their own physician.

Off-Label Drug Use [posted 8/11/98]
Question: Has the drug hydroxychloroquine sulfate (Plaquenil) been tested for its activity against viral syndromes like HIV disease? HIV patients have told me that it has measurably improved their condition (doubled CD4+ T- cell counts - from 350 cells/mm^3 to 600+ cells/mm^3) for over one year. Where should I look for possible trials of this drug against HIV? Would its manufacturer (Sanofi Winthrop) keep records of all trials of their products?

Answer: I really don't keep up with new experimental treatments in HIV since that is a full time job and I use ID specialists for input as I need it. However, I would check (or have your physician check) with the scientific department of Sanofi: 800-446-6267.

Off Label Use
Question: Where do physicians find information on off-label uses of FDA approved products and experimental drugs? Where do consumers/patients find the same?

Answer: Physicians use drugs for unapproved uses by understanding the pharmacology of the drug and the purpose for which they intend it. There are many examples of physicians using drugs for unapproved uses. For a company to get a use approved takes many studies and lots of time and money. Physicians are not bound by these rules. Understanding a drug and its side effects will predict whether it will have a use which is "unapproved".
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