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Recombinant activated factor VII (rFVIIa; NovoSeven) is FDA-approved for treatment of patients with hemophilia or any of several other congenital or acquired coagulation disorders. However, it also is used off-label in patients with central nervous system bleeding and in patients with severe hemorrhage related to trauma, surgery, or liver disease. In randomized controlled trials of these off-label uses, rFVIIa generally has failed to prevent death, and its effect on blood loss has varied.
Thromboembolism is an important potential complication of rFVIIa use. To determine the incidence of this complication, researchers analyzed data from 35 randomized placebo-controlled trials of off-label rFVIIa use in more than 4000 people. The drug was asso…