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In a study published August 6, Mayo Clinic researchers reported that many patients are unaware that their doctors are prescribing medications for off-label use. A patient is using a drug for off-label use when the FDA hasn’t approved the way it’s being administered, its dosage, or what it’s being used to treat. Technically, a doctor doesn’t have to disclose that he’s prescribing a drug off-label.

“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, an internal medicine physician with the Mayo Clinic and the lead researcher in the study.

A 2006 report showed that about 1 in 5 of the most commonly prescribed medications was prescribed for off-label use, including:

  • antidepressants;
  • bronchodilators;
  • anticonvulsants;
  • antimicrobials;
  • protein pump inhibitors; and
  • morphine.

While doctors are allowed to promote the off-label use of drugs, drug makers are not. Several companies have paid millions and even billions of dollars for promoting and marketing the off-label use of their prescription medications. Merck Sharp & Dohme paid a fine of $322 million for allegedly promoting the off-label use of Vioxx, while GlaxoSmithKline was fined $3 billion for allegedly marketing the off-label use of various drugs.

Physicians like Dr. Wittich encourage patients to do more research about the off-label use of prescription drugs, especially if they are currently taking them.

"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," he said.

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