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The practice of off-label use of prescriptionmedications occurs in approximately 1in every 5 scripts filled in the United States.This practice is potentially risky because75% of these off-label uses do not haveextensive scientific support, according tostudy results reported in the Archives ofInternal Medicine (May 8, 2006). Once theFDA approves a drug for 1 indication, physicianscan prescribe it for other uses.

For the study, the researchers determinedthe frequency of and reasons foroff-label use by looking at a 2001 surveythat examined patterns for 160 routinelyprescribed drugs from office-based physicians.That year, there were an estimated150 million off-label scripts written, or 21%of the total. Of those, 27% were for indicationssupported by scientific evidence. Yet,the remaining 73% (109 million prescriptions)had little or no evidence supportingthe use in question.

The investigators concluded that off-labeluse needs better scrutiny. Physicians, too,need to be alert to the potential positiveand negative outcomes. This type of surveillance,lead author Randall Stafford, MD,PhD, said, "would be particularly importantfor off-label uses which haven't gonethrough that initial step of being reviewedby the FDA."

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