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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)

April 29 - 30, 2008
Natcher Conference Center

Agenda

April 29, 2008 Transcripts
April 30, 2008 Transcripts

Review of Publicly Available Reports of Adverse Events Associated with HBOCs (PDF - 144 KB)

Introduction

The Food and Drug Administration (FDA), the National Heart, Lung and Blood Institute, National Institutes of Health; and the Department of Health and Human Service's Office of the Secretary and Office of Public Health and Science (OS/OPHS) co-sponsored a public workshop entitled: "Hemoglobin Based Oxygen Carriers: Current Status and Future Directions." The purpose of the public workshop was to discuss the safety of hemoglobin-based oxygen carriers (HBOCs) as related to a variety of potential uses of these investigational products. This discussion was held because clinical and nonclinical studies of HBOCs, as either blood substitutes or as resuscitation fluids, had raised questions about the safety of these products as a group.

Topics discussed included oxygen and nitric oxide physiology in relation to hemoglobin and HBOCs in general and an overview of the biochemical and physiological aspects of HBOCs with special emphasis on the strengths and limitations of animal studies. The workshop featured presentations by manufacturers of HBOCs on their experiences gained in the course of development of these products. Roundtable discussions by experts in different disciplines focused on organ specific adverse effects seen with a variety of HBOCs and potential underlying mechanisms. The workshop concluded with presentations on finding ways forward in terms of biochemical mitigation strategies, animal studies and alternative focused clinical designs.