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Original Report

Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008†

  1. Ann W. McMahon1,*,
  2. Robert G. Pratt1,
  3. Tarek A. Hammad1,
  4. Steven Kozlowski2,
  5. Esther Zhou1,
  6. Susan Lu1,
  7. Corrinne G. Kulick1,
  8. Tarun Mallick3,‡,
  9. Gerald Dal Pan1

Article first published online: 26 JUL 2010

DOI: 10.1002/pds.1991

Issue

Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and Drug Safety

Volume 19, Issue 9, pages 921–933, September 2010

Additional Information

How to Cite

McMahon, A. W., Pratt, R. G., Hammad, T. A., Kozlowski, S., Zhou, E., Lu, S., Kulick, C. G., Mallick, T. and Dal Pan, G. (2010), Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008. Pharmacoepidem. Drug Safe., 19: 921–933. doi: 10.1002/pds.1991

Author Information

  1. 1

    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

  2. 2

    Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

  3. 3

    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

  1. ‡

    Current affiliation: Public Health Consultant to the World Bank, 11534 Olde Tiverton Circle, Apt 101, Reston, 20194, VA.

*Food and Drug Administration, 10903 New Hampshire Avenue, Room 3474, Silver Spring, MD 20993, USA.

  1. †

    This article is a US Government work and is in the public domain in the USA.

Publication History

  1. Issue published online: 25 AUG 2010
  2. Article first published online: 26 JUL 2010
  3. Manuscript Accepted: 10 MAY 2010
  4. Manuscript Revised: 6 MAY 2010
  5. Manuscript Received: 28 DEC 2009

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Keywords:

  • heparin;
  • adverse events;
  • contamination

Abstract

Purpose

To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007–early 2008 during a national investigation of allergic-type events. The investigation identified Baxter Healthcare-brand heparin product due to its strongest association with the events. Later, oversulfated chondroitin sulfate (OSCS), a heparin-like contaminant, was discovered.

Methods

This study was a case series of heparin reports in AERS received 1 January 2008 to 31 March 2008. Variables considered were frequency of treatment settings, AEs, mortality; as well as heparin dose and OSCS contamination.

Results

Five hundred seventy-four AERS cases (unduplicated reports) were identified and included. Of 94 cases with a fatal outcome, 68 reported at least one AE term from the list used to identify an allergic-type event. Nearly 75% of AEs in cases of IV administration (n = 170/233) reportedly occurred within 10 minutes, whereas over half of subcutaneous administration cases (n = 13/23) resulted in times-to-event of greater than 24 hours. Although cases with a time-to-event of less than 10 minutes appeared to correlate with higher levels of OSCS contamination, no clear differences were noted between high- and low-to-absent OSCS concentration lots with respect to AEs observed.

Conclusions

Intravenous administration and a higher OSCS concentration appeared to correlate with a more rapid onset of event. The FDA continues to monitor AEs associated with heparin use and has taken appropriate regulatory action to ensure a safe heparin drug supply. Published in 2010 by John Wiley & Sons, Ltd.

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