Ready to upload
Adverse Occurrence type:
Case report and serologic investigation of 7 WinRho lots
Time to detection:
Within 1 hour
Alerting signals, symptoms, evidence of occurrence:
The patient received WinRho 27.7 mg per kg and within 1 hour of administration, she experienced severe rigors, back pain, headache, chills and hemoglobinuria.
Demonstration of imputability or root cause:
Clinical history supports acute hemolytic reaction.
Gaines, A.R., Lee-Stroka, H., Byrne, K., Scott, D.E., Uhl, L., Lazarus,E. and Stroncek, D.F. (2009). 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 49(6):1050-1058.
Expert comments for publication:
A significant drop in hemoglobin following administration of WinRho to a Rh(D)+ recipient for ITP is not unexpected, but the intravascular nature of the reaction in this patient is more pronounced than many other recipients. The investigation of this and other lots suggests that the severity of the reaction may be more of a recipient specific sensitivity than a direct and predictable result of the lot.