|
|
 Previous Article | Table of Contents | Next Article 
Blood, Vol. 95 No. 8 (April 15), 2000:
pp. 2523-2529
Acute onset hemoglobinemia and/or hemoglobinuria and sequelae
following Rho(D) immune globulin intravenous administration
in immune thrombocytopenic purpura patients
Ann Reed Gaines
From the Office of Biostatistics and Epidemiology, Center for
Biologics Evaluation and Research, Food and Drug Administration,
Rockville Pike, Rockville, MD.
Rho(D) immune globulin intravenous (anti-D IGIV) was
licensed by the United States Food and Drug Administration (FDA) in
March 1995 to treat patients with immune thrombocytopenic purpura
(ITP). Anti-D IGIV induces extravascular hemolysis, an expected adverse reaction that is consistent with the presumed mechanism of action. Between licensure and April 1999, the FDA received 15 reports of
hemoglobinemia and/or hemoglobinuria following anti-D IGIV administration that met the case definition for this review. The mechanism responsible for hemoglobinemia and/or hemoglobinuria is
unexplained. Review of these reports was prompted by the seriousness and the unexpectedness of treatment-associated sequelae experienced by
11 patients. Of these patients, 7 developed sufficient onset or
exacerbation of anemia that orders were written for packed red blood
cell transfusions, although only 6 patients were transfused. Eight
patients experienced the onset or exacerbation of renal insufficiency,
and 2 patients underwent dialysis. One patient died due to
complications of exacerbated anemia. Six patients experienced 2 to 3 sequelae. Absent validated incidence data, a 1.5% estimated incidence
rate from published clinical trial data and a 0.1% estimated reporting
rate from FDA and drug utilization data were calculated for reported
cases of hemoglobinemia and/or hemoglobinuria. This review presents the
first case series of anti-D-IGIV-associated hemoglobinemia and/or
hemoglobinuria and provides pretreatment and posttreatment clinical and
laboratory findings of the case series patients. The primary purpose of
this review is to increase awareness of this potentially serious
occurrence among physicians and health care professionals who manage
ITP patients treated with anti-D IGIV, thereby enabling prompt
recognition and treatment of sequelae.
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati What's this?
This article has been cited by other articles:
|
|
|
|
 
C. E. Neunert, G. R. Buchanan, P. Imbach, P. H. B. Bolton-Maggs, C. M. Bennett, E. J. Neufeld, S. K. Vesely, L. Adix, V. S. Blanchette, T. Kuhne, et al.
Severe hemorrhage in children with newly diagnosed immune thrombocytopenic purpura
Blood,
November 15, 2008;
112(10):
4003 - 4008.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. J. Alter and H. G. Klein
The hazards of blood transfusion in historical perspective
Blood,
October 1, 2008;
112(7):
2617 - 2626.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. D. Tarantino, J. B. Bussel, D. B. Cines, K. R. McCrae, T. Gernsheimer, H. A. Liebman, W.-Y. Wong, R. Kulkarni, E. Grabowski, and R. McMillan
A closer look at intravascular hemolysis (IVH) following intravenous anti-D for immune thrombocytopenic purpura (ITP)
Blood,
June 15, 2007;
109(12):
5527 - 5527.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. R. Gaines
Response: Further examination of intravascular hemolysis (IVH) following intravenous anti-D for immune thrombocytopenic purpura (ITP)
Blood,
June 15, 2007;
109(12):
5528 - 5528.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Schwartz, S. Spitalnik, and K. M. Grima
Severe hemolysis following administration of Rho(D) immune globulin in an ITP patient associated with anti-C.
Blood,
March 15, 2006;
107(6):
2585 - 2585.
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. B. Cines and J. B. Bussel
How I treat idiopathic thrombocytopenic purpura (ITP)
Blood,
October 1, 2005;
106(7):
2244 - 2251.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. R. Cohen
Anti-D immune globulin: protecting platelets at a cost
Blood,
September 1, 2005;
106(5):
1510 - 1510.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. R. Gaines
Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura
Blood,
September 1, 2005;
106(5):
1532 - 1537.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M Trifa, L Simon, J Hamza, F Bavoux, and N B. des Roziers
Haemolytic anaemia associated with high dose intravenous immunoglobulin therapy in a child with Guillain-Barre syndrome
Arch. Dis. Child.,
September 1, 2003;
88(9):
836 - 837.
[Full Text]
|
|
|
|
|
|
|
G. Lemm
Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy
Neurology,
December 24, 2002;
59(90126):
S28 - 32.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
D. B. Cines and V. S. Blanchette
Immune Thrombocytopenic Purpura
N. Engl. J. Med.,
March 28, 2002;
346(13):
995 - 1008.
[Full Text]
[PDF]
|
|
|
|
|
|
|
H J Longhurst, C O'Grady, G Evans, C De Lord, A Hughes, J Cavenagh, and M R Helbert
Anti-D immunoglobulin treatment for thrombocytopenia associated with primary antibody deficiency
J. Clin. Pathol.,
January 1, 2002;
55(1):
64 - 66.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P H B Bolton-Maggs
Current topic: Idiopathic thrombocytopenic purpura
Arch. Dis. Child.,
September 1, 2000;
83(3):
220 - 222.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
