Disseminated intravascular coagulation associated with acute hemoglobinemia and/or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura Short title for running head: DIC associated with acute hemoglobinemia and/or hemoglobinuria following anti-D IGIV administration for ITP

The Food and Drug Administration (FDA) licensed Rho(D) immune globulin intravenous (anti-D IGIV) on March 24, 1995 for treatment of immune thrombocytopenic purpura (ITP). A previous review described 15 patients who experienced acute hemoglobinemia and/or hemoglobinuria following anti-D IGIV administration for ITP or secondary thrombocytopenia. Eleven of those patients also experienced clinically compromising anemia, transfusion with packed red blood cells, renal insufficiency, dialysis, and/or death. That review suggested that patients receiving anti-D IGIV be monitored for those and other potential complications of hemoglobinemia, particularly disseminated intravascular coagulation (DIC). Through November 30, 2004, FDA received 6 reports of DIC associated with “acute hemolysis” (or similar terms), 5 of which involved fatalities. The attending or consulting physicians assessed that acute hemolysis and/or DIC caused or contributed to each death. This review presents the first case series of DIC associated with acute hemoglobinemia and/or hemoglobinuria following anti-D IGIV administration. The purpose of this review is to increase awareness among physicians and other health care professionals that DIC may be a rare but potentially severe complication of anti-D IGIV treatment. Increased awareness of DIC as a diagnostic possibility may enable prompt recognition and medical intervention in affected patients.