Emerging off-label uses for recombinant activated factor VII: grading the evidence.
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.
Division 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.
T Miko
TM
Enomoto
Per
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Thorborg
D000328:Adult; D000368:Aged; D001777:Blood Coagulation / Q000187:drug effects / Q000502:physiology*; D003422:Critical Care / Q000379:methods*; D019317:Evidence-Based Medicine; D005167:Factor VII / Q000502:physiology / Q000627:therapeutic use; D015942:Factor VIIa; D006467:Hemophilia A / Q000188:drug therapy*; D006470:Hemorrhage / Q000188:drug therapy*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D011994:Recombinant Proteins / Q000097:blood / Q000627:therapeutic use
D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa