Nature Medicine | Spoonful of Medicine

EDITORIAL: When off label is off target

Off-label prescribing of drugs can add to a clinician’s toolbox, but it may also pose risks to patients. Careful monitoring and clinical validation should increase the safety and guarantee the efficacy of using existing drugs for new indications.

Once again, off-label prescribing has stirred controversy and concerns. The publication of three studies showing compelling evidence of health risks associated with off-label use—and abuse in some hospitals—of the hemostatic agent recombinant factor VIIa (rFVIIa) raises questions as to how to properly regulate off-label drug use. The worrisome new findings call for a reassessment of the tools used by the US Food and Drug Administration (FDA) to examine the frequency of this practice among clinicians and the reasons encouraging doctors to prescribe off-label usage.

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