----- Original Message -----
From: Terry S. Singeltary Sr.
To: [email protected]
Cc: [email protected] ; [email protected]
Sent: Thursday, February 09, 2006 9:12 AM
Subject: New case (3RD) of variant CJD associated with blood transfusion
Press Statement
9 February 2006
New case of variant CJD associated with blood transfusion
A new case of variant-CJD associated with a blood transfusion has recently been diagnosed. The patient developed symptoms of vCJD about 8 years after receiving a blood transfusion from a donor who developed symptoms of vCJD about 20 months after donating this blood. The patient is still alive and is under the care of doctors at the National Prion Clinic.
This third occurrence of vCJD infection associated with blood transfusion is further evidence that vCJD can be transmitted between humans by blood transfusion. All three cases to date relate to the transfusion of blood components and not treatment with plasma products.
The patient is one of a small number (less than 30) of living individuals who are known to have received a blood transfusion in the UK from a donor who later developed vCJD. All these individuals have previously been informed of their potential exposure to vCJD and asked to take certain precautions to reduce the chance of passing on vCJD on to other people via healthcare procedures, such as surgery.
Professor Peter Borriello, Director of the HPA's Centre for Infections said, "The occurrence of a third case of vCJD infection in a small group of patients like this suggests that blood transfusion from an infected donor may be a relatively efficient mechanism for the transmission of vCJD, although much still remains unknown. This underlines the importance of the existing precautions that have been introduced to reduce the risk of transmitting vCJD infection through blood transfusion.
"We have been in contact with the doctors caring for the other patients who have been exposed to blood transfusion from donors who later developed vCJD. This is to ensure that these patients are informed of this new development and have access to the latest information and to specialist advice about their situation."
Dr Angela Robinson, Medical Director of NHS Blood and Transplant said, "Our thoughts go out to the patient and their family. Our prime concern is always the safety of patients through maintaining the quality of blood and we have introduced a range of precautionary measures against the risk of vCJD. Blood transfusion is often a life saving treatment and the benefit of receiving a blood transfusion when needed far outweighs any possible risks"
vCJD is a rare disease, and only less than 2% of the 160 vCJD cases to date in the UK have been associated with blood transfusion.
Notes to Editors
1. 'Blood Transfusion' means transfusion with labile blood components (e.g. red cells, platelets, fresh frozen plasma). This latest case (and the previous two referred to) relate to transfusion of blood components and not treatment with plasma products (i.e. products that are manufactured from plasma). To date, no case of vCJD has been associated with treatment with plasma-products (e.g. clotting factors used to treat individuals with bleeding disorders such as haemophilia).
2. This third case has been classified by the National CJD Surveillance Unit (http://www.cjd.ed.ac.uk ) as a 'probable' case of vCJD. Of the 154 vCJD cases that have died, all 110 that have undergone post-mortem (44 have not) have been 'confirmed' by neuropathological examination (examination of brain tissue).
3. The first clinical case of vCJD associated with transfusion was identified in December 2003. A case vCJD 'infection' associated with transfusion was identified a few months later. (the patient had no symptoms but evidence of infection (abnormal prion proteins) was identified in a post mortem investigation. The individual died from causes unrelated to vCJD.
4. Following the first case of vCJD associated with a blood transfusion in 2003, the Department of Health asked all recipients of blood transfusions not to donate blood as a precautionary measure to protect the blood supply from vCJD.
5. Patients who have received blood transfusion (i.e. blood components) and certain patients who have received plasma products made from blood donated by a donor who later developed vCJD are informed that they are considered to be 'at risk for public health purposes' and are asked to take the following precautions to reduce the chance of passing on vCJD to other people:
Not to donate blood, tissues or organs and
To inform their healthcare providers of their 'at-risk' status so that special procedures may be arranged for certain instruments used in their healthcare
6. A range of measures have been put in place by the Department of Health to minimise the possible risk of VCJD being passed through blood:
Since 1997 all cases of vCJD that are reported to the National CJD Surveillance Unit and diagnosed as having 'probable' vCJD, result in a search of the UK Blood Services blood donor records. If the patient has donated blood, any unused parts of that blood are immediately removed from stock. The fate of all used components of blood from the donor is traced, and surviving recipients informed of their risk.
In July 1998, the Department of Health announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources.
Since October 1999, white blood cells (which may carry the greatest risk of transmitting vCJD) have been removed from all blood used for transfusion.
In August 2002 the Department of Health announced that fresh frozen plasma for treating babies and young children born after 1 January 1996 would be obtained from the USA, extended to all children under 16 years of age (Summer 2005).
In December 2002, the Department of Health completed its purchase of the largest remaining independent US plasma collector, Life Resources Incorporated. This secures long-term supplies of non-UK blood plasma for the benefit of NHS patients.
Since April 2004, blood donations have not been accepted from people who have themselves received a blood transfusion in the UK since 1980. This has been extended to include apheresis donors and donors who are unsure if they had previously had a blood transfusion (August 2004).
The UK Blood Services continue to promote the appropriate use of blood and tissues and alternatives throughout the NHS.
7. The likelihood of a person who may be infected with vCJD going onto develop symptoms of the disease is uncertain, and may depend on individual susceptibility. It is possible that infected individuals may never develop symptoms.
8. For further information contact the HPA press office on 0208 327 7098/7097/6055
9. The National Prion Unit is based at The Hospital for Neurology and Neurosurgery, Queen Square , London http://www.nationalprionclinic.org/
10. For further information about vCJD go to:
http://www.hpa.org.uk/infections/topics_az/cjd/menu.htm
http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en
http://www.blood.co.uk/
http://www.cjd.ed.ac.uk
http://www.nationalprionclinic.org/
http://www.hpa.org.uk/hpa/news/articles/press_releases/2006/060209_cjd.htmtss
PRODUCT
Source Plasma, Recall # B-0584-6
CODE
Units VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html
PRODUCT
Red Blood Cells, Recall # B-0552-6
CODE
Unit number: 4426304
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
END OF ENFORCEMENT REPORT FOR JANUARY 25, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.html
===================================
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0492-6;
b) Recovered Plasma, Recall # B-0497-6
CODE
a) and b) Unit number: 4101212
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone and facsimile on March 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
_______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html
PRODUCT
Source Plasma, Recall # B-0391-6
CODE
Unit number: 7030260750
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone on September 29, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Recall # B-0456-6;
b) Recovered Plasma, Recall # B-0457-6
CODE
a) Unit number: 06FR39967;
b) Unit numbers: 06FR37676, 06FR39967
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, California, by telephone on June 2, 2002, and by letter dated, June 20, 2002, and by facsimile transmission dated June 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk of variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and Switzerland
_______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html
TSS
From: Terry S. Singeltary Sr.
To: [email protected]
Cc: [email protected] ; [email protected]
Sent: Thursday, February 09, 2006 9:12 AM
Subject: New case (3RD) of variant CJD associated with blood transfusion
Press Statement
9 February 2006
New case of variant CJD associated with blood transfusion
A new case of variant-CJD associated with a blood transfusion has recently been diagnosed. The patient developed symptoms of vCJD about 8 years after receiving a blood transfusion from a donor who developed symptoms of vCJD about 20 months after donating this blood. The patient is still alive and is under the care of doctors at the National Prion Clinic.
This third occurrence of vCJD infection associated with blood transfusion is further evidence that vCJD can be transmitted between humans by blood transfusion. All three cases to date relate to the transfusion of blood components and not treatment with plasma products.
The patient is one of a small number (less than 30) of living individuals who are known to have received a blood transfusion in the UK from a donor who later developed vCJD. All these individuals have previously been informed of their potential exposure to vCJD and asked to take certain precautions to reduce the chance of passing on vCJD on to other people via healthcare procedures, such as surgery.
Professor Peter Borriello, Director of the HPA's Centre for Infections said, "The occurrence of a third case of vCJD infection in a small group of patients like this suggests that blood transfusion from an infected donor may be a relatively efficient mechanism for the transmission of vCJD, although much still remains unknown. This underlines the importance of the existing precautions that have been introduced to reduce the risk of transmitting vCJD infection through blood transfusion.
"We have been in contact with the doctors caring for the other patients who have been exposed to blood transfusion from donors who later developed vCJD. This is to ensure that these patients are informed of this new development and have access to the latest information and to specialist advice about their situation."
Dr Angela Robinson, Medical Director of NHS Blood and Transplant said, "Our thoughts go out to the patient and their family. Our prime concern is always the safety of patients through maintaining the quality of blood and we have introduced a range of precautionary measures against the risk of vCJD. Blood transfusion is often a life saving treatment and the benefit of receiving a blood transfusion when needed far outweighs any possible risks"
vCJD is a rare disease, and only less than 2% of the 160 vCJD cases to date in the UK have been associated with blood transfusion.
Notes to Editors
1. 'Blood Transfusion' means transfusion with labile blood components (e.g. red cells, platelets, fresh frozen plasma). This latest case (and the previous two referred to) relate to transfusion of blood components and not treatment with plasma products (i.e. products that are manufactured from plasma). To date, no case of vCJD has been associated with treatment with plasma-products (e.g. clotting factors used to treat individuals with bleeding disorders such as haemophilia).
2. This third case has been classified by the National CJD Surveillance Unit (http://www.cjd.ed.ac.uk ) as a 'probable' case of vCJD. Of the 154 vCJD cases that have died, all 110 that have undergone post-mortem (44 have not) have been 'confirmed' by neuropathological examination (examination of brain tissue).
3. The first clinical case of vCJD associated with transfusion was identified in December 2003. A case vCJD 'infection' associated with transfusion was identified a few months later. (the patient had no symptoms but evidence of infection (abnormal prion proteins) was identified in a post mortem investigation. The individual died from causes unrelated to vCJD.
4. Following the first case of vCJD associated with a blood transfusion in 2003, the Department of Health asked all recipients of blood transfusions not to donate blood as a precautionary measure to protect the blood supply from vCJD.
5. Patients who have received blood transfusion (i.e. blood components) and certain patients who have received plasma products made from blood donated by a donor who later developed vCJD are informed that they are considered to be 'at risk for public health purposes' and are asked to take the following precautions to reduce the chance of passing on vCJD to other people:
Not to donate blood, tissues or organs and
To inform their healthcare providers of their 'at-risk' status so that special procedures may be arranged for certain instruments used in their healthcare
6. A range of measures have been put in place by the Department of Health to minimise the possible risk of VCJD being passed through blood:
Since 1997 all cases of vCJD that are reported to the National CJD Surveillance Unit and diagnosed as having 'probable' vCJD, result in a search of the UK Blood Services blood donor records. If the patient has donated blood, any unused parts of that blood are immediately removed from stock. The fate of all used components of blood from the donor is traced, and surviving recipients informed of their risk.
In July 1998, the Department of Health announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources.
Since October 1999, white blood cells (which may carry the greatest risk of transmitting vCJD) have been removed from all blood used for transfusion.
In August 2002 the Department of Health announced that fresh frozen plasma for treating babies and young children born after 1 January 1996 would be obtained from the USA, extended to all children under 16 years of age (Summer 2005).
In December 2002, the Department of Health completed its purchase of the largest remaining independent US plasma collector, Life Resources Incorporated. This secures long-term supplies of non-UK blood plasma for the benefit of NHS patients.
Since April 2004, blood donations have not been accepted from people who have themselves received a blood transfusion in the UK since 1980. This has been extended to include apheresis donors and donors who are unsure if they had previously had a blood transfusion (August 2004).
The UK Blood Services continue to promote the appropriate use of blood and tissues and alternatives throughout the NHS.
7. The likelihood of a person who may be infected with vCJD going onto develop symptoms of the disease is uncertain, and may depend on individual susceptibility. It is possible that infected individuals may never develop symptoms.
8. For further information contact the HPA press office on 0208 327 7098/7097/6055
9. The National Prion Unit is based at The Hospital for Neurology and Neurosurgery, Queen Square , London http://www.nationalprionclinic.org/
10. For further information about vCJD go to:
http://www.hpa.org.uk/infections/topics_az/cjd/menu.htm
http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en
http://www.blood.co.uk/
http://www.cjd.ed.ac.uk
http://www.nationalprionclinic.org/
http://www.hpa.org.uk/hpa/news/articles/press_releases/2006/060209_cjd.htmtss
PRODUCT
Source Plasma, Recall # B-0584-6
CODE
Units VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html
PRODUCT
Red Blood Cells, Recall # B-0552-6
CODE
Unit number: 4426304
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
END OF ENFORCEMENT REPORT FOR JANUARY 25, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.html
===================================
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0492-6;
b) Recovered Plasma, Recall # B-0497-6
CODE
a) and b) Unit number: 4101212
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone and facsimile on March 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
_______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html
PRODUCT
Source Plasma, Recall # B-0391-6
CODE
Unit number: 7030260750
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone on September 29, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Recall # B-0456-6;
b) Recovered Plasma, Recall # B-0457-6
CODE
a) Unit number: 06FR39967;
b) Unit numbers: 06FR37676, 06FR39967
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, California, by telephone on June 2, 2002, and by letter dated, June 20, 2002, and by facsimile transmission dated June 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk of variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and Switzerland
_______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html
TSS
