Recombinant factor VIIa (Novoseven) and the safety of treatment

Recombinant factor VIIa (rFVIIa; NovoSeven), Novo Nordisk, Bagsvaerd, Denmark) has been used to treat more than 6,500 patients with hemophilia or other bleeding disorders, and by May 2001, more than 180,000 standard doses had been administered. Clinical experience to date suggests that rFVIIa is safe and effective, with a very low incidence of thrombotic events being reported. Moreover, in the majority of cases, thrombotic events appear to be caused by improvements in the hemostatic system, rather than a direct effect of the agent itself.