Patients Often Kept in Dark About 'Off-Label' Drug Use: Study

WEDNESDAY Aug. 8, 2012 -- Many patients who are being treated with "off-label" drugs are unaware that the medications they have been prescribed by their doctor aren't being used in ways that would meet U.S. Food and Drug Administration approval, research shows.

Off-label drug use is a term used to describe when a medication is prescribed using a dosage, form of dosage, or for a purpose that hasn't yet been approved by the FDA, the researchers explained in the report published online Aug. 6 in the Mayo Clinic Proceedings.

"Since the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common," study lead author Dr. Christopher Wittich, an internal medicine physician at the Mayo Clinic in Rochester, Minn., said in a clinic news release. "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 revealed that among the most common medications, roughly one in five prescriptions was for an off-label use, the researchers pointed out. For example, some antidepressants are considered a primary treatment for neuropathic pain, although this use is not FDA-approved.

Morphine, as well as many inhaled bronchodilators, antimicrobials, anticonvulsants and proton pump inhibitors are also prescribed for children without being FDA-approved for use in kids. Previous research has shown that about 79 percent of kids were taking at least one off-label medication when they were discharged from a children's hospital, the study authors noted in the release.

Because doctors are not required to disclose the off-label use of a drug, and are also not liable for off-label drug use, patients are commonly not told that they are taking a drug in a way that is not FDA-approved, the researchers pointed out.

Drug makers, however, are not allowed to promote off-label uses of their drugs. Doing so can result in hefty fines, the study authors explained. For example, GlaxoSmithKline recently agreed to pay a record $3 billion to settle a case involving alleged off-label drug-use marketing, and Merck Sharp & Dohme was fined $322 million for allegedly promoting the painkiller Vioxx for an off-label use.

But, Wittich and colleagues noted, drug companies are allowed to respond to questions from health care providers and distribute peer-reviewed publications about off-label drug use.

The high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication, the researchers suggested.

More information

The American Cancer Society has more about off-label drug use.

Posted: August 2012


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