Patients may not be aware that they are prescribed medication to treat a condition before that use has been approved by the FDA, according to research from the Mayo Clinic.
Researchers from the Mayo Clinic found that though off-label drug use is common, patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn't regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn't make physicians liable for off-label drug use.
"Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common," said lead author Christopher Wittich, MD, internal medicine physician at Mayo Clinic. "Healthcare 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."
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Researchers from the Mayo Clinic found that though off-label drug use is common, patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn't regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn't make physicians liable for off-label drug use.
"Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common," said lead author Christopher Wittich, MD, internal medicine physician at Mayo Clinic. "Healthcare 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."
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