Increased Prevalence of Antiheparin Platelet Factor 4 Antibodies in Patients May Be Due to Contaminated Heparin

Author:

Adiguzel Cafer1,Bansal Vinod2,Litinas Evangelos1,Cunanan Josephine1,Iqbal Omer1,Nelson Kelly1,Kannan Meganathan3,Hoppensteadt Debra4,Fareed Jawed5

Affiliation:

1. Department of Pathology, Loyola University Medical Center, Maywood, Illinois

2. Division of Nephrology, Department of Medicine, Loyola University Medical Center, Maywood, Illinois

3. Center for Biologics Evaluation and Research, FDA Division of Hematology, Bethesda, Maryland

4. Department of Pharmacology, Loyola University Medical Center, Maywood, Illinois

5. Department of Pharmacology, Loyola University Medical Center, Maywood, Illinois,

Abstract

During the period of November 2007 to January 2008, an increased prevalence of adverse reactions to heparin was noted. These adverse events have been attributed to the presence of purposeful contaminant, oversulfated chondroitin sulfate (OSCS) from April 2007 to May 2008. An analysis of dialysis patients' plasma obtained in 2006 and 2007 consistently had a low (5%) prevalence of AHPF4 antibodies. Blood samples from 78 patients on maintenance hemodialysis, who were potentially exposed to OSCS-contaminated heparin, were analyzed for the presence of all AHPF4 antibodies using a commercially available ELISA kit from GTI. Although there was no change in the platelet count of these patients, 15 of 78 patients (19.2%) studied had an increased prevalence of AHPF4 antibodies. Subtyping of the all platelet factor 4 (PF4) antibodies documented showed a higher prevalence of immunoglobulin G antibodies as compared to their previously determined antibodies. These observations suggest that the OSCS contaminant in the recalled heparin triggers an immunogenic response not seen with OSCS-contaminated free heparin.

Publisher

SAGE Publications

Subject

Hematology,General Medicine

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