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Drugs Most in Need of Research for Off-Label Uses Identified

Panel recommends 14 FDA-approved drugs undergo extensive study to validate their safety and efficacy in their most popular off-label uses

THURSDAY, Nov. 27 (HealthDay News) -- A list of 14 U.S. Food and Drug Administration-approved medications most in need of research to determine their safety and efficacy in off-label use is published in the December issue of the journal Pharmacotherapy.

Surrey M. Walton, Ph.D., of the University of Illinois-Chicago, and colleagues convened an expert panel of representatives from the FDA, academia, and the health insurance and pharmaceutical industries. This panel identified three factors to prioritize drugs most in need of further research for their off-label uses: the volume of off-label drug use without supporting scientific data; the safety profile of the drug; and a composite measure reflecting the drug's cost, length on the market, and amount of money spent on its marketing.

After collecting the data according to these three factors, 14 drugs consistently ranked high. Many of these were antidepressants, including escitalopram, bupropion, sertraline, venlafaxine, duloxetine and trazodone. Several antipsychotics were also identified, such as quetiapine, risperidone and olanzapine. Other drugs on the list included warfarin, montelukast, celecoxib, lisinopril and epoetin alfa.

"Off-label prescribing means that we're venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective," said study author Randall Stafford, M.D., Ph.D., in a statement. "This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence," he added.

Abstract
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Physician's Briefing
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