Use of recombinant factor VIIa for the prevention and treatment of bleeding in patients without hemophilia: a systematic review and meta-analysis.

A systematic review and a meta-analysis that confirms what we have known for some time now: the benefits of rFVIIa as a general hemostatic agent in patients without hemophilia remain unproven (see Hardy JF, Belisle S, Van der Linden P. Efficacy and safety of recombinant activated factor VII to control bleeding in nonhemophiliac patients: a review of 17 randomized controlled trials. Ann Thorac Surg 2008;863):1038-48). Amalgamating studies probably diluted the arterial thrombotic effect of rFVIIa found in some patient populations, especially elderly patients. Consequently, its use outside hemophilia should be considered with extreme caution and, in the vast majority of cases, restricted to clinical trials. Given the widespread off-label use of rFVIIa, this recommendation, unfortunately, comes close to wishful thinking

– Jean-Franois Hardy