Thrombocytopenic Purpura

Findings from Food & Drug Administration advance knowledge in thrombocytopenic purpura

Thrombocytopenic Purpura Library Library Home This article was published in Biotech Business Week, which you can subscribe to online.

"In transfusion medicine, the red blood cell (RBC) antigen-antibody incompatibility(-ies) that precipitate AHTRs can be detected in vitro with compatibility testing. Under the premise that anti-D-IGIV-associated acute hemolysis results from RBC antigen-antibody-mediated complement activation, this study evaluated whether the incompatibility(-ies) could be detected in vitro with a hemolysin assay, which would support the AHTR model as the hemolytic mechanism. Seven anti-D IGIV lots were tested to determine the RBC antibody identities in those lots, including four lots that had been implicated in acute hemolytic episodes. Hemolysin assays were performed that tested each of 73 RBC specimens against each lot, including the RBCs of one patient who had experienced acute hemolysis after anti-D IGIV administration. Only two anti-D IGIV lots contained RBC antibodies beyond those expected. No hemolysis endpoint was observed in any of the hemolysin assays," wrote A.R. Gaines and colleagues, Food & Drug Administration.

The researchers concluded: "Although the findings did not support the AHTR model, the results are reported to contribute knowledge about the mechanism of anti-D-IGIV-associated acute hemolysis and to prompt continued investigation into cause(s), prediction, and prevention of this potentially serious adverse event.."

Gaines and colleagues published their study in Transfusion (Investigation of whether the acute hemolysis associated with Rh-o(D) immune globulin intravenous (Human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model. Transfusion, 2009;49(6):1050-1058).

For more information, contact A.R. Gaines, Food & Drug Administration, Center Biology Evaluation & Research, Off Biostatistics & Epidemiology, Off Blood Research & Review, 1401 Rockville Pike, Rockville, MD 20852, USA.

Publisher contact information for the journal Transfusion is: Wiley-Blackwell Publishing, Inc., Commerce Place, 350 Main St., Malden 02148, MA, USA.

Keywords: United States, Rockville, Angiology, Antiinfective, Blood Transfusion, Drugs, Hematology, Hemolysis, Hemolytic, Immune Globulin Intravenous, Immune globulin, Immunomodulatory, Intravascular, Medical Device, Therapy, Thrombocytopenia, Thrombocytopenic Purpura, Transfusion Medicine, Treatment, Food & Drug Administration.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.