Guest guest Posted February 14, 2006 Report Share Posted February 14, 2006 What the drug is approved to treat. http://www.fda.gov/cder/news/thalinfo/thalfaq.htm Some legal issues. http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11/ Q. What is " Off Label " Prescribing? A. When the FDA approves a medical device or drug, it is approved for use only against the condition/disease that it was tested against during the clinical trials process. Once it is on the market, a healthcare professional may write a prescription for a patient that has a different condition/disease. This is called " off-label " prescribing. While this is perfectly legal, you should remember that using the drug fto treat this other condition/disease was not scrutinized under the quality control protection of the FDA's clinical trials process. Be sure to ask your doctor why it is being prescribed for you and weigh the risks and benefits with special attention. You should have a " right to know " if a prescription is actually approved by the FDA for the condition for which it is being prescribed, or if it is an Off-Label Prescription. Many think the FDA has approved Thalidomide for MM. Unless the FDA has just recently made such an approval, I think it is still an " Off-Label " prescription. Dottie Quote Link to comment Share on other sites More sharing options...
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