AHRQ Studies Off-Label Use of Recombinant Factor VIIa

Since 2000, off-label use of recombinant activated factor VII (rFVIIa) in the hospital setting in cases of in cases of spontaneous intracranial hemorrhage, bleeding secondary to trauma, and cardiac surgery has increased despite limited comparative data on its effectiveness and safety. The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program has produced a guide for clinicians, Utilization and clinical Data on In-Hospital Off-label Uses of Recombinant Factor VIIa and a CME module, Comparative Effectiveness of In-Hospital Off-Label Use of Recombinant Factor VIIa vs. Usual Care, that offers an AMA PRA Category 1 Credit

The study found that despite increased off-label usage, for the uses examined, current evidence does not show reduction in mortality or improvement in other direct outcomes. Thromboembolic events are increased when rFVIIa is used to treat spontaneous intracranial hemorrhage and in adult cardiac surgery

The guide for clinicians and the CME module are free and can be accessed through the AHRQ Effective Health Care Web site, www.effectivehealthcare.ahrq.gov . Guides can be ordered by calling 1-(800) 358-9295, or e-mailing ahrqpubs@ahrq.gov.

The clinician guide and the CME module were produced by AHRQ’s Effective Health Care Program, the leading federal effort to conduct patient-centered outcomes research. The program is intended to help patients, doctors, nurses, pharmacists and others aware of the most effective treatment options.

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