Babesiosis & blood transfusion - FDA reports

Discussion in 'Lyme Disease Archives' started by victoria, Jan 20, 2009.

  1. victoria

    victoria New Member

    Babesia Infection through Blood Transfusions: Reports Received by the US
    Food and Drug Administration, 1997–2007
    Diane M. Gubernot, Charles T. Lucey, Karen C. Lee, Gilliam B. Conley,
    Leslie G. Holness, and Robert P. Wise

    Clinical Infectious Diseases 2009;48:25–30
    http://dx.doi.org/10.1086/595010

    *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.

    Received 19 August 2008; accepted 1 October 2008; electronically
    published 26 November 2008.

    Data in this article are based on information provided to the US Food
    and Drug Administration in required reports of potentially
    transfusion?related deaths.

    http://dx.doi.org/10.1086/595010
  2. mrdad

    mrdad New Member

    Thanks Victoria, for your informative Post! I think we have a tendency to believe that the
    "regulators" are doing their jobs, even with protecting our health. As was demonstrated
    in the near past, the RED CROSS admitted that they hadn't screened blood adequately in
    accordance with such mandated protocol. I've suggested here b-4, and repeat that it would
    be best advised for one to donate one's own blood just prior to any elective surgery! Unless,
    of course, one holds unquestionable trust in those responsible for assuring blood purity.

    Thanks,
    MrDAD
    [This Message was Edited on 02/05/2009]