Most transfusion services adopt a policy recommending Novo Nordisk’s recombinant activated factor VIIa (rFVIIa, NovoSeven®) in acute hemorrhage when conventional therapy; RBCs, frozen plasma, platelet concentrate, and cryoprecipitate fail to stop the bleeding. NovoSeven is FDA-cleared for prophylaxis or therapy in hemophilia A or B patients with inhibitors or people with congenital factor VII deficiency. When it is used to stop non-hemophilic bleeding in the operating or emergency room or on the battlefield, however, this is off-label. Several studies have implied that NovoSeven may trigger arterial or venous thrombosis when used in high-risk patients such as those with previous thrombotic disorders. The US legal system has seized on this information, and now the Sunday, May 16 Baltimore Sun alleges a criminal investigation of military usage in Iraq, placing Novo Nordisk and the Army in a defensive position. There is no question that NovoSeven rescues patients who are “going south” on the table. Many of us have witnessed abrupt turn-arounds in which patients stop bleeding, restore electrolyte balance, recover from hypothermia, and raise their blood pressure.Thirty-day outcomes, however, seem to indicate no significant long-term improvement. I’d like to hear from you, what is your institution’s policy regarding the use of NovoSeven, how successful is it, and have you personally witnessed clinical “rescues.”
May 21 2010
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