Recombinant FVIIa in the management of uncontrolled XXXX .

@entity1 @entity295 @entity548 @entity447 @entity3459 @entity1031 @entity881 @entity715 @entity204
BACKGROUND: Recombinant FVIIa (rFVIIa/NovoSeven) is a novel hemostatic agent originally developed to treat @entity1 with @entity447 who had developed inhibitors. Several case reports have suggested that rFVIIa may be effective in treating @entity1 without a pre-existing @entity3459 who have uncontrolled @entity548 . STUDY DESIGN AND METHODS: Data on the efficacy and safety of rFVIIa in the treatment of @entity548 were obtained retrospectively from the NovoSeven extended-use data collection system. RESULTS: A total of 40 @entity1 received rFVIIa for uncontrolled @entity548 , and in these @entity1 , @entity548 stopped or decreased in 32 (80%). Blood product usage was significantly decreased after rFVIIa administration. @entity1031 events occurred in three @entity1 with additional risk factors for @entity715 . Of 40 @entity1 , 23 (57.5%) died. Bleeding was the direct cause of @entity204 in seven cases (all within 24 hr of administration of rFVIIa). The remaining 16 deaths were the result of @entity295 , @entity881 , or the underlying disease. CONCLUSIONS: In this retrospective study of data voluntarily submitted to a web-based drug surveillance program, we present preliminary results on the use of rFVIIa in nonhemophilia @entity1 with @entity548 . Although some efficacy is suggested, there was a high mortality rate from nonhemorrhagic causes. Randomized controlled trials are needed to properly assess the role of rFVIIa in the management of @entity548 .
