Thromboembolic Complications Associated with the Use of Prothrombin Complex and Factor IX Concentrates

Michael Köhler; Peter Hellstern; Eckhard Lechler; Peter Überfuhr; Gert Müller-Berghaus

doi:10.1055/s-0037-1615219

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1998; 80(03): 399-402
DOI: 10.1055/s-0037-1615219

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Thromboembolic Complications Associated with the Use of Prothrombin Complex and Factor IX Concentrates

Michael Köhler

¹From the Department of Transfusion Medicine, University of Göttingen, Institute of Haemostaseology and Transfusion Medicine, Ludwigshafen, Clinic of Internal Medicine, University of Cologne, Clinic of Cardiosurgery, University of Munich (Grosshadern), Department of Haemostaseology and Transfusion Medicine, Bad Nauheim, Germany

,

Peter Hellstern

¹From the Department of Transfusion Medicine, University of Göttingen, Institute of Haemostaseology and Transfusion Medicine, Ludwigshafen, Clinic of Internal Medicine, University of Cologne, Clinic of Cardiosurgery, University of Munich (Grosshadern), Department of Haemostaseology and Transfusion Medicine, Bad Nauheim, Germany

,

Eckhard Lechler

¹From the Department of Transfusion Medicine, University of Göttingen, Institute of Haemostaseology and Transfusion Medicine, Ludwigshafen, Clinic of Internal Medicine, University of Cologne, Clinic of Cardiosurgery, University of Munich (Grosshadern), Department of Haemostaseology and Transfusion Medicine, Bad Nauheim, Germany

,

Peter Überfuhr

¹From the Department of Transfusion Medicine, University of Göttingen, Institute of Haemostaseology and Transfusion Medicine, Ludwigshafen, Clinic of Internal Medicine, University of Cologne, Clinic of Cardiosurgery, University of Munich (Grosshadern), Department of Haemostaseology and Transfusion Medicine, Bad Nauheim, Germany

,

Gert Müller-Berghaus

¹From the Department of Transfusion Medicine, University of Göttingen, Institute of Haemostaseology and Transfusion Medicine, Ludwigshafen, Clinic of Internal Medicine, University of Cologne, Clinic of Cardiosurgery, University of Munich (Grosshadern), Department of Haemostaseology and Transfusion Medicine, Bad Nauheim, Germany

› Author Affiliations

Abstract

Summary

In 1994, shortly after a heat-treated prothrombin complex concentrate (PCC) had been withdrawn from the German market due to transmission of hepatitis B, the license of another brand was withdrawn, due to 3 acute fatalities associated with the use of this product. We report on the clinical data of altogether 5 patients, who died during a 3 month period in Germany after having received this brand of PCC. All patients had surgery, acquired deficiencies of coagulation factors, and underlying diseases predisposing for thrombosis or disseminated intravascular coagulation. PCC was administered for the prevention of bleeding. In three patients, a drug interaction of PCC with aprotinin may also have played a role. Several points, however, are suspicious of a major causative effect of the respective product, (a) the close temporal correlation between administration of the drug and the subsequent clinical as well as laboratory deterioration, (b) the accumulation of these adverse events in a short period of time, when the use and market share of this brand increased due to the shortage of other products, and (c) laboratory abnormalities of this brand which have been consistently observed in several in vitro studies.

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References

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