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Patients Unaware of Off-label Drug use

Thursday, 09 August 2012 11:47 AM

Physicians frequently prescribe drugs for off-label uses for which they have not been officially approved, and many patients are not aware of it – even when it involves the medications they are taking, a new Mayo Clinic analysis has found.
Off-label drug use occurs when a physician legally prescribes medication to treat a condition, based on a belief that it is an effective therapy, before that use has been approved by the Food and Drug Administration.
"Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common," said Dr. Christopher Wittich, who led the analysis, published in the Mayo Clinic Proceedings. "Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one."
Among the findings of the analysis, which was based on a review of off-label studies:
• Roughly 1 in 5 commonly prescribed drugs is for an off-label use. About 79 percent of children discharged from pediatric hospitals were taking at least one off-label medication.
• Patients may not know when drugs they have been prescribed are being used off-label, since no law requires physicians to disclose such information or can hold them liable.
• Off-label drug use can become the predominant treatment for a condition. For example, some antidepressants are not approved by the FDA as a treatment for neuropathic pain, yet some drugs in this class are a first-line treatment option.
• Examples of widely practiced off-label drug use: morphine, inhaled bronchodilators, antimicrobials, anticonvulsants, and proton pump inhibitors.

© HealthDay

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Physicians frequently prescribe drugs for off-label uses, but many patients involved may not be aware of it.
Thursday, 09 August 2012 11:47 AM
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