Safety update on recombinant factor VIIa in the treatment of congenital and acquired hemophilia.

Recombinant activated factor VII (rFVIIa) appears to be safe when used for its licensed indication of congenital and acquired hemophilia A or B with inhibitors. One should carefully consider the clinical indication for which the agent is used when patient risk factors are present that might predispose the subject to a thromboembolic (TE) event, or when concomitant hemostatic agents are being used. Additionally, one should exercise caution if there is evidence of activated coagulation, such as that seen with excessive tissue factor release or disseminated intravascular coagulation. However, the incidence of serious TE events in hemophilia patients with inhibitors treated with rFVIIa appears to be much less than 1%. The role of rFVIIa in off-label indications should be assessed through rigorously controlled clinical trials or by analyzing carefully collected data from national and international registries.