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Emerging off-label uses for recombinant activated factor VII: grading the evidence
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
Summary
Recombinant activated factor VII (rFVIIa) is approved for specific bleeding disorders but its use is expanding. Further research is needed to evaluate the efficacy, cost, and safety of these new applications.
Area of Science:
- Hematology
- Coagulation Science
Background:
- Recombinant activated factor VII (rFVIIa) is approved for treating bleeding in patients with factor VIII or IX deficiencies and inhibitors.
- A case report on rFVIIa's use in severe hemorrhage without coagulopathy has spurred interest in broader applications.
Purpose of the Study:
- To explore the expanding uses of rFVIIa beyond its current indications.
- To address the emerging questions regarding the coagulation system, rFVIIa efficacy, cost-effectiveness, and safety.
Main Methods:
- Review of existing literature and case reports.
- Analysis of proposed new indications for rFVIIa.
Main Results:
- The use of rFVIIa has expanded significantly following a report of its efficacy in a non-hemophiliac patient with severe bleeding.
- Numerous potential new applications for rFVIIa are being investigated.
Conclusions:
- The expanding applications of rFVIIa necessitate a deeper understanding of coagulation.
- Critical evaluation of rFVIIa's efficacy, cost-effectiveness, and safety in new indications is required.