Off-label drug uses increases risk of negative side effects, study says

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About 12 percent of drugs doctors prescribe are for uses other than those approved by regulators, a recent study found. So-called off-label prescribing significantly raises the rate of negative side effects, the research showed.

Doctors are free to prescribe medications off-label, and in some cases patients benefit from those prescriptions. Physicians may find that an off-label drug is more effective at treating a problem than medications specifically approved for that use. For example, amitriptyline, approved to treat depression, is often used off-label for migraines.

The study, published in the journal JAMA Internal Medicine in November, suggests doctors should take greater care in choosing when to use off-label drugs and to more closely monitor patients receiving them, said Chester Good, a physician with the Department of Veterans Affairs, VA Pittsburgh, who co-wrote an editorial accompanying the study.

“I’m not saying that physicians shouldn’t be using drugs off-label, it happens all the time,” Dr. Good said. “But we need to be more circumspect when we do so. Indications should either be supported by some evidence or recommended in guidelines.”

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