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Off-Label Drug Use a Mystery to Most Patients

Filed August 13th, 2012 Laurie

A large number of patients being treated with a drug for “off-label” purposes aren’t aware that the problem it was prescribed to them to treat isn’t what it was approved for.
While drug companies are not permitted to market drugs for off-label drug uses by law, physicians are within their full rights to prescribe them to patients for unapproved uses.
Since doctors are not required to disclose the off-label use of a drug, they also are not liable for off-label drug use.

“Since the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” said Dr. Christopher Wittich, the lead author of a report published online Aug. 6 in the Mayo Clinic Proceedings, and an internal medicine physician at the Mayo Clinic in Rochester, Minn. “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.”

A 2006 report found that roughly one in five prescriptions was for an off-label use.
Antidepressants are considered a primary treatment for neuropathic pain, though it is not FDA-approved.

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