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Health Care Reform
October 26, 2009

Going Off-label Without Venturing Off-CourseEvidence and Ethical Off-label Prescribing

Arch Intern Med. 2009;169(19):1745-1747. doi:10.1001/archinternmed.2009.314

Following US Food and Drug Administration (FDA) approval, clinicians may lawfully prescribe a drug or biologic agent for treatment regimens not specified in the approved labeling or package insert. This is known as off-label use. A recent study1 found that for 160 common drugs in the United States, off-label use accounted for 21% of all prescriptions. Many off-label uses are accepted as standard of care, for example, use of β-blockers for congestive heart failure. Many other off-label uses, however, lack evidence of clinical efficacy.1 In light of growing concerns about appropriateness and cost, off-label use has been identified as 1 aspect of problematic drug prescribing.2,3

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