Con: The Role of Recombinant Factor Vila in the Control of Bleeding AfterCardiac Surgery

摘要

RECOMBINANT FACTOR VIIa (rFVHa) (NovoSeven; Novo Nordisk, Bagsvaerd, Denmark) was introduced into clinical practice almost 20 years ago. The United States Food and Drug Administration (FDA) licensed it in March 1999 for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors (antibodies) to factor VIII or IX, respectively. The FDA extended the license in lanuary 2005 to include the use in surgical procedures in hemophilia A and B patients with inhibitors, congenital factor VII deficiency, and Glanzmann's thromboasthenia. Europe and other countries all over the world followed the same licensure indications as the FDA. Soon after the initial license, within the same year, rFVIIa was reported to be successfully used in 1 trauma patient and 2 surgical patients, which opened the door widely for extended "off-label" use of the drug in almost all types of bleeding patients who were deemed to suffer from "intractable hemorrhage" irrespective of the cause with success in some casesbut with failure and/or complications in others.