Doctors unaware of many drug approval uses

Aug. 24, 2009 at 7:11 PM
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CHICAGO, Aug. 24 (UPI) -- Some physicians erroneously think certain off-label uses of prescription drugs are approved by the U.S. Food and Drug Administration, researchers said.

Corresponding author Dr. G. Caleb Alexander of the University of Chicago Medical Center said this mistaken belief could encourage doctors to prescribe the drugs, despite the lack of scientific evidence supporting such use.

The FDA approves drugs for marketing with an official "label" that stipulates an indication, dose, intended population, duration of use and other specifications. However, physicians and other licensed prescribers can prescribe any approved drug for any indication, whether or not the indication is included on the drug's FDA-approved label, Alexander said.

Alexander and colleagues surveyed 1,199 physicians -- 599 primary care physicians and 600 psychiatrists -- in 2007-2008 and included 22 drug-indication pairs, drugs approved for on-label use to off-label use supported by medical evidence to off-label use deemed to be ineffective.

The study, published in Pharmacoepidemiology and Drug Safety, found overall, physicians were able correctly to identify the FDA-approval status of just over half of the 22 drug-indication pairs.

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