Transfusion-associated Babesia infections: Reports received by the FDA 1997 to 2008

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Background: Babesiosis is a known transfusion-transmitted disease risk and there is no FDA-licensed test for donor screening. Approximately 80 transfusion-transmitted cases have been reported 1979 through 2008. This research evaluated the Babesia-related transfusion events reported to the Food and Drug Administration (FDA) with particular focus on numbers and characteristics of transfusion-related babesiosis fatality reports.

Methods: Data were collected from FDA's Blood Collection and Transfusion Fatality Reporting and Biological Product Deviation Reports (BPDRs) surveillance systems.

Results: From 2005 through 2008, the FDA received 10 transfusion-related babesiosis fatality reports after only one prior report in 1998. Recipients presented with symptoms 2.5 to 9 weeks after transfusion of implicated red blood cell units. In recent years, FDA has also seen an increase in Babesia-related BPDRs involving donors with post donation illness and reports of potential transfusion-transmitted disease. Most reports submitted to the FDA implicate B. microti.

Conclusion: The reports received by the FDA indicate Babesia infection may be a rare but increasing risk to the blood supply. Without a licensed screening test to prevent these transmissions, enhanced clinician awareness of the possibility of babesiosis in febrile, recent transfusion recipients may facilitate prompt diagnosis, improved prognosis, and more timely investigations to interdict infected units. Prompt reporting of babesiosis donor and transfusion-related events assists the FDA in assessing the scope of this risk and developing appropriate public health control measures.

Disclaimer: The findings and conclusions in this abstract have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.