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Off-Label NovoSeven

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.”

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