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From: TSS ()
Subject: Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products
Date: March 16, 2007 at 9:05 am PST

Thursday, March 15, 2007


Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD)
From Plasma-Derived Products

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.

This web page provides FDA’s risk assessment for US licensed pdFVIII and risk communication materials for this product and other plasma derivatives. Included are Key Points, and Questions and Answers. Additional links are provided to FDA’s current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD, and to other sources of information regarding vCJD.

Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX

Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points
Risk Assessment (PDF, 582 KB)
Risk Assessment Appendix (PDF, 623 KB)
Questions and Answers on vCJD and pdFVIII
Questions and Answers on vCJD and Plasma Derivatives Other than pdFVIII
Guidance on Donor Deferral Related to CJD and vCJD

Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" - 8/2006
Questions and Answers on FDA Guidance: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob (CJD) Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/22/2004
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/2002
Other Sources of Information

Transmissible Spongiform Encephalopathies Advisory Committee
Blood Products Advisory Committee Meeting – Summary of Recent TSEAC Meeting and Statement about FXI from the UK, on October 21, 2004
Information on vCJD: Centers for Disease Control and Prevention
Information on Bovine Spongiform Encephalopathy (“Mad Cow Disease”): US Department of Agriculture
Patient Organizations:

Committee of Ten Thousand
Hemophilia Federation of America
National Hemophilia Foundation and/or HANDI
World Federation of Hemophilia

http://www.fda.gov/cber/blood/vcjdrisk.htm

PRODUCT
Recovered Plasma, Recall # B-0854-07
CODE
Unit: V10665
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by email on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 14, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00995.html

nvCJD mad cow blood recalls ENFORCEMENT REPORT FOR MARCH 7, 2007

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0805-07;
b) Platelets, Recall # B-0806-07;
c) Recovered Plasma, Recall # B-0807-07
CODE
a) Units: 4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574, 4555912
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, OK, TX, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0808-07;
b) Platelets, Recall # B-0809-07;
c) Recovered Plasma, Recall # B-0810-07
CODE
a), b), and c) Unit: 5249546
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on August 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK, NB, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0811-07;
b) Recovered Plasma, Recall # B-0812-07
CODE
a) and b) Unit: 5218775
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0826-07;
b) Platelets, Recall # B-0827-07;
c) Fresh Frozen Blood, Recall # B-0828-07;
d) Recovered Plasma, Recall # B-0829-07
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units: 4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527, 4901850
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, TX, Austria, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0843-07;
b) Recovered Plasma, Recall # B-0844-07
CODE
a) and b) Units: 5738052, 5275313, 4801421
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX, OK, and Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 7, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html

4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD

By Terry S Singeltary

Bacliff, Texas USA Jan 24, 07

4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.

snip...

4. Members had received information about the notification by the Health
Protection Agency (HPA) of recipients of four batches of plasma products
that had been produced from blood donated by individuals that had later
developed variant Creutzfeldt Jakob Disease (vCJD). THESE batches HAD NOT
been included in a similar notification exercise in 2004, as the fate of
these products COULD NOT BE TRACED at that time. The fourteenth annual
report of the National CJD Surveillance Unit had been published. The
European Food Safety Authority (EFSA) had issued a consultation on a revised
methodology for geographical bovine spongiform encephalopathy (BSE) risk
assessment. Members could submit individual responses. Submission of a SEAC
response was under consideration.

snip...

ITEM 9 - ANY OTHER BUSINESS

snip...

***$$$***

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.

http://www.seac.gov.uk/minutes/95.pdf

snip...full text ;

http://bloodindex.org/view_news_zone.php?id=206


PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr. ; [log in to unmask]
Cc: [log in to unmask] ; [log in to unmask]
Sent: Thursday, November 30, 2006 1:47 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART II]


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=16159


part 1


http://bsw-uiuc.net/phpBB2/viewtopic.php?p=354&sid=971c807e383ef9e5f99ffff9da002535


TSS




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