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» LymeNet Flash » Questions and Discussion » Medical Questions » Food and Drug Administration...have Safety of Donated Blood on the Agenda

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Author Topic: Food and Drug Administration...have Safety of Donated Blood on the Agenda
Melanie Reber
Frequent Contributor (5K+ posts)
Member # 3707

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Food and Drug Administration, Department of Health and Human Services, Centers for Disease Control and American Red Cross have Safety of Donated Blood on the Agenda Sept. 10-12

Last update: 4:23 p.m. EDT Sept. 3, 2008
Sep 03, 2008 (BUSINESS WIRE) -- MEDIA ADVISORY:

WHAT: Officials from the U.S. Food and Drug Administration Blood Products
Advisory Committee (BPAC) will meet with government institutions and
top experts from academia and private industry on September 10, 11
and 12 in two separate meetings to address issues related to safety
of the blood supply including:

-- Bacterial contamination of donated blood products for transfusion
which can lead to sepsis (Sept. 10)

-- Risk of infectious disease such as malaria from blood donors
traveling abroad, and impact on donor pool and blood shortages
(Sept. 11)

-- Emerging concerns of U.S. diseases spread by ticks like babesiosis
and lyme disease (Sept. 12)


WHY: All of these organizations are committed to ensuring the safety of
the nation's blood supply. Recent fines against the American Red
Cross have shed public light on concerns around contaminants in the
blood supply and areas for improving blood product safety. For
example:

-- 125 blood transfusion related fatalities were reported to the FDA in
2005 and 2006(1)

-- 1 in 3,000 units of platelet blood components are believed to be
bacterially contaminated at time of transfusion(2) putting 1 in 500
patients at risk for sepsis (based on an average of 6 units of
platelets per transfusion)

-- West Nile Virus took four years to identify and arguably more than
3,200 people were infected through blood transfusion(3)

-- FDA reported a total of five deaths related to
transfusion-transmitted babesiosis in 2006 and 2007(4)


The FDA BPAC and Department of Health and Human Services Advisory
Committee on Blood Safety and Availability (ACBSA) have previously
met to discuss strategies to improve blood safety, including
pathogen inactivation, a proactive approach to eradicate
bacteria, viruses and pathogens from the blood supply.

HOW: Pathogen inactivation technologies have the ability to inactivate
bacteria, viruses and parasites from donated blood that may not be
detected by current diagnostic tests. Many European countries are
currently using pathogen inactivation to safeguard their blood
supply.

WHO: Speakers will include representatives from the American Red Cross,
Centers for Disease Control, academic and industry experts.
Learn more about areas for improvement of blood safety or to speak
to an expert about pathogen inactivation and its anticipated
benefits to the U.S. blood supply by speaking with:

-- Dr. Jeff McCullough, M.D., American Red Cross Professor, Transfusion
Medicine, Professor, Laboratory Medicine & Pathology, University of
Minnesota

-- Dr. Larry Corash, M.D., Chief Medical Officer, Cerus Corporation

WHEN /
WHERE: FDA Meeting: Blood Products Advisory Committee
Sept. 10, 2008, 8:00 a.m. to 5:45 p.m.
Sept. 11, 2008, 8:00 a.m. to 3:00 p.m.
Hilton Hotel, Washington, D.C./Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD 20852

Complete BPAC Meeting Agenda: http://www.fda.gov/CbER/advisory/bp/bp0908.htm
FDA Workshop: Risk of Transfusion-Transmitted Babesiosis in the
United States
Sept. 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
FDA Workshop Announcement: http://www.fda.gov/Cber/meetings/ttb091208.htm
FDA Workshop Agenda: http://www.fda.gov/Cber/meetings/ttb091208ag.htm

1 FDA Web site http://www.fda.gov/cber/blood/fatal0506.htm as of Sept. 3, 2008
2 CDC Web site at Fatal Bacterial Infections Associated with Platelet Transfusions found at this link http://www.cdc.gov/mmwR/preview/mmwrhtml/mm5407a2.htm as of May 9, 2008
3 HJ Alter. Pathogen Reduction: A precautionary principle paradigm. Transfusion Medicine Reviews. Vol. 22, 2 April 2008
4 FDA Web site announcing FDA Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States at http://www.fda.gov/cber/meetings/ttb091208.htm as of August 27, 2008
SOURCE: FDA BPAC

Porter Novelli Life Sciences
Megan Lavine, 619-849-5388
[email protected]

http://tinyurl.com/6m3lmk

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ldfighter
LymeNet Contributor
Member # 9405

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Very interesting. This is from the babesia workshop link:

http://www.fda.gov/cber/meetings/ttb091208.htm

"We are convening this workshop at the present time because FDA has observed a recent increase in the number of reports of transfusion-transmitted babesiosis..."

"...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..."

"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."

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bettyg
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finally ...
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h8lyme
LymeNet Contributor
Member # 11765

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in a case like this how long would it take for symptoms to start to show up? I'm asking because I had surgery back in 2002, but I didn't get sick till 2006. Could my system have held off the bacteria for 4 years?

I don't ever recall being bit by a tick. This just makes me think.

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PinchotGail
LymeNet Contributor
Member # 5066

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If we only had crystal balls!!

I think the answer is, it is possible.

Everyone is different and immune systems can fight off things for varying amounts of time.

--------------------
Strength does not come from physical capacity. It comes from an
indomitable will ~ Gandhi

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Peedie
LymeNet Contributor
Member # 15355

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Thanks everyone for the replies. I emailed Melanie's information to her and I will follow up with a phone call to encourage her to get on antibiotic. I'm going to push for a full 400mg. Doxy for at least 4 weeks.
She could not donate her blood first - she had a bleeding ulcer and by the time she decided she needed help - it was an emergency situation.
She is such a good person - very caring - but does not take care of herself - always her work can't wait.
Peedie

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