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Emerging off-label uses for recombinant activated factor VII: grading the evidence

T Miko Enomoto1, Per Thorborg

  • 1Division of Surgical Critical Care, Department of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code L 223, Portland, OR 97201-3098, USA.

Critical Care Clinics
|July 5, 2005
PubMed

Recombinant activated factor VII (rFVIIa) is currently licensed in the United States for treatment of bleeding episodes in patients with deficiencies of factor VIII (FVIII) or IX (FIX) who are refractory to factor replacement because of circulating inhibitors. A 1999 report of its successful use to stop what was deemed to be lethal hemorrhage after an abdominal gunshot wound in a young soldier without pre-existing coagulopathy has prompted exploration of other uses for rFVIIa. The virtual explosion of proposed uses of rFVIIa raises issues not only regarding our understanding of the coagulation system, but also regarding its efficacy, cost-effectiveness, and safety.

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