Document Detail


Babesia infection through blood transfusions: reports received by the US Food and Drug Administration, 1997-2007.
MedLine Citation:
PMID:  19035776     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Human babesiosis is an illness with clinical manifestations that range from asymptomatic to fatal. Although babesiosis is not nationally notifiable, the US incidence appears to be increasing. Babesia infection is a transfusion-transmissable disease. An estimated 70 cases were reported during 1979-2007; most of these cases were reported during the past decade. METHODS: We queried the 3 following US Food and Drug Administration safety surveillance systems to assess trends in babesiosis reporting since 1997: fatality reports for blood donors and transfusion recipients, the Adverse Event Reporting System (which includes MedWatch), and the Biological Product Deviations Reporting system.We analyzed fatality reports for time frames, clinical presentations, and patient and donor demographic characteristics. RESULTS: Eight of 9 deaths due to transfusion-transmitted babesiosis that were reported since 1997 occurred within the past 3 years (2005-2007). Four implicated donors and 5 patients lived in areas where Babesia infection is not endemic. Increasing numbers of Biological Product Deviations Reports were submitted to the US Food and Drug Administration over the past decade; the Adverse Event Reporting System received no reports. CONCLUSIONS: After nearly a decade with no reported death due to transfusion-transmitted babesiosis, the US Food and Drug Administration received 8 reports from November 2005 onward. The increased numbers of deaths reported and Biological Product Deviations Reports suggest an increasing incidence of transfusion-transmitted babesiosis. Physicians should consider babesiosis in the differential diagnosis in immunocompromised, febrile patients with a history of recent transfusion, even in areas where Babesia infection is not endemic. Accurate and timely reporting of babesiosis-related donor and transfusion events assists the US Food and Drug Administration in developing appropriate public health-control measures.
Authors:
Diane M Gubernot; Charles T Lucey; Karen C Lee; Gilliam B Conley; Leslie G Holness; Robert P Wise
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  48     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2008-12-10     Completed Date:  2009-01-02     Revised Date:  2009-06-08    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  25-30     Citation Subset:  IM    
Affiliation:
Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852-1448, USA. diane.gubernot@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Babesiosis / epidemiology*,  etiology*,  mortality
Blood Transfusion / adverse effects*
Female
Humans
Incidence
Male
Middle Aged
United States
United States Food and Drug Administration
Comments/Corrections
Comment In:
Clin Infect Dis. 2009 Jul 1;49(1):166-7   [PMID:  19500034 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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