FDA Workshop
to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States
September 12, 2008
7:30 a.m. - 5:30 p.m.
Lister Hill Center Auditorium, Building 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894
Babesiosis is a malaria-like illness caused by infection of erythrocytes with protozoan parasites belonging to the genus Babesia. Transfusion- transmitted babesiosis is caused by transfusion of blood or blood components collected from donors infected with Babesia parasites. During the last 40 years, more than 60 cases of transfusion-transmitted babesiosis have been recognized in the United States. In years 2006 and 2007, FDA received a total of five reports of fatal transfusion-transmitted babesiosis (primary or contributory cause of death) in the United States.
The purpose of the public workshop was to discuss the risk and possible approaches to minimize the incidence of transfusion-transmitted babesiosis in the United States. FDA convened this workshop because FDA observed a recent increase in the number of reports of transfusion-transmitted babesiosis, thus warranting additional discussion to address this blood safety issue. In addition, the workshop discussed the potential for transmission of Babesia infection by transplantation of cells and tissue products. The public workshop featured presentations and roundtable discussions led by experts from academic institutions, government and industry. Topics to be discussed include: (1) Biology, pathogenesis, transmission and epidemiology of babesiosis; (2) risk of Babesia infections through transfusion of blood and blood components; (3) laboratory methods to detect Babesia infections; and, (4) possible approaches, including donor deferral, and donor testing to reduce the risk of transfusion-transmitted babesiosis while minimizing the loss of otherwise suitable donors.