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Only after careful and extensive review of all available safety  and efficacy data derived from preclinical and clinical trials  will a regulatory body approve the licensing of a drug for a  specific medical condition ('indication'). Experience with  thalidomide, fialuridine and troglitazone, to name a few, reveal  that despite these efforts, the process is not infallible. What  then can we expect when a drug is used for a medical condition  in which no such review process has been undertaken ('offlabel'  use of the drug)

Think Stop before Going 'Off-Label'