Mayo Clinic: Patients in the dark about prescriptions
  • Thu, 08/09/2012 - 3:36pm

In a recent Mayo Clinic report, researchers revealed that doctors often fail to inform patients when they prescribe a medication for “off-label” purposes.

“Since the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” reported Dr. Christopher Wittich, lead author of the study and an internal medicine physician at the Mayo Clinic in Rochester, Minnesota. “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.”

In the study, published online August 6 in the Mayo Clinic Proceedings, researchers said that “off-label” use of a drug occurs when a doctor prescribes a medication to treat a patient, but the FDA has not approved the drug for that type treatment. Other cases of off-label use occur when doctors prescribe a drug for the treatment of part of the population that the FDA has not approved. For example, some doctors prescribe medications for children despite the fact that the drug has only been approved for use in adults.

A drug’s label contains the information concerning uses of a drug, any adverse side effects of the drug and the drug’s approval by the FDA.

The FDA does not ask doctors to report off-label uses of drugs, so it cannot hold them accountable for prescribing drugs for off-label uses. However, the FDA does require drug companies to stick to the approved uses of its drug. If drug manufacturers try to sell their product for “off-label” purposes, the agency can fine them large sums of money.

Doctors’ widespread practice of prescribing drugs for off-label uses requires patients to educate themselves about the medications they take. Engaging one’s physician in conversation goes a long way to aid a patient in making informed decisions about their healthcare.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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