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

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

Michael Köhler
1   From 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
1   From 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
1   From 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
1   From 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
1   From 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
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Publikationsverlauf

Received 23. Dezember 1997

Accepted after resubmission 07. April 1998

Publikationsdatum:
08. Dezember 2017 (online)

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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In 1994, shortly after a heat-treated prothrombin complex concentrate (PCC) had been withdrawn from the German market due to transmission of hepatitis B, the license of another brand was withdrawn, due to 3 acute fatalities associated with the use of this product.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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