The off-label use of recombinant human coagulation factor VIIa has been increasing to a number of different
treatment areas since its original approval in 1999. Several US patents describe claims for FVIIa utilization in nonhemophilia
patients, treatment of bleeding due to trauma, as a means to reverse major bleeding, including intracranial
bleeding, induced from fibrinolytic therapy as well as a patent for using FVIIa in the treatment of bleeding for patients
with bleeding disorders not caused by hemophilia, but rather bleeding disorders due to thrombocytopenia, platelet disorders,
and von Willebrand’s disease. Bleeding after cardiac surgery remains a serious complication that can increase both
morbidity and mortality. We review the off-label usage of recombinant factor VIIa as a hemostatic agent that may help
control bleeding following cardiac surgery.