flatfish
05-02-2007, 11:36 AM
Subject: MAD COW BLOOD RECALL DONOR INCREASED RISK FOR nvCJD was distributed
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1221-07
CODE
Unit: 7113661
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1222-07;
b) Recovered Plasma, Recall # B-1223-07
CODE
a) and b) Units: 5587539, 9710079
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and e-mail beginning August 10, 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
4 units
DISTRIBUTION
LA and Switzerland
___________________________________
END OF ENFORCEMENT REPORT FOR MAY 2, 2007
###
http://www.fda.gov/bbs/topics/enforce/2007/ENF01002.html
USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
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.
snip...
http://www.seac.gov.uk/minutes/95.pdf
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.
***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resources-casereport.html
There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.
He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
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
___________________________________
continued
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1221-07
CODE
Unit: 7113661
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1222-07;
b) Recovered Plasma, Recall # B-1223-07
CODE
a) and b) Units: 5587539, 9710079
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and e-mail beginning August 10, 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
4 units
DISTRIBUTION
LA and Switzerland
___________________________________
END OF ENFORCEMENT REPORT FOR MAY 2, 2007
###
http://www.fda.gov/bbs/topics/enforce/2007/ENF01002.html
USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
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.
snip...
http://www.seac.gov.uk/minutes/95.pdf
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.
***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resources-casereport.html
There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.
He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
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
___________________________________
continued