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  4. Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points
  1. Safety & Availability (Biologics)

Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points

Summary Information

Key Points:

  • In recent years, questions have been raised concerning the risk of variant Creutzfeldt-Jakob disease (vCJD) (a rare but fatal brain infection) to hemophilia A and von Willebrand disease patients who receive US licensed plasma-derived Factor Eight (pdFVIII, Antihemophilic Factor) products.
  • Based on a risk assessment, the US Public Health Service (PHS), including FDA, CDC, and NIH, believes that the risk of vCJD to hemophilia A and von Willebrand disease 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.
  • Contacting a specialist in hemophilia or von Willebrand disease at a Hemophilia Treatment Center is a good way to learn about new information as it becomes available.

Additional Information:

  • Between December 2003 and April 2007, there have been four reports of people, all in the UK, who probably acquired the vCJD agent through red blood cell transfusions. This has increased concern about the potential transmission of vCJD by blood products.
  • Principal concerns are whether persons infected with vCJD could donate plasma in the U.S., and whether clotting factor products made from their plasma donations might transmit the disease.
  • To address these concerns FDA recommends the deferral of donors who may have lived in or traveled extensively to countries with a higher prevalence of vCJD and bovine spongiform encephalopathy (BSE) than in the U.S.
  • In the United States, pdFVIII products have not been made from the plasma of anyone known to have developed vCJD, and no one who received any of these products is known to have developed vCJD.
  • FDA conducted a risk assessment for pdFVIII because the plasma fraction from which it is made is likely to contain more of the vCJD infectious agent, if present, than plasma fractions from which other plasma-derived products are made, such as Factor IX, (used to treat hemophilia B), albumin, and immune globulins. The FVIII-containing fraction is further processed using a variety of methods that are likely to reduce or potentially eliminate vCJD from the final pdFVIII product. Methods likely to reduce or potentially eliminate vCJD are also used in the manufacture of other plasma-derived products.
  • FDA, CDC, and NIH are not aware of any cases of vCJD having been reported worldwide in patients with hemophilia, von Willebrand disease, or other blood clotting disorders. This includes those who have received, over a long period of time, large amounts of blood clotting factor products manufactured from plasma donations from the UK where the risk of vCJD is highest because of a previous higher risk of potential exposure to BSE- infected beef in the UK diet.
  • The FDA has taken a number of steps to further reduce the potential vCJD risk from blood components. These steps include donor deferral recommendations, and quarantine and withdrawal of products at increased vCJD risk. Donor deferral guidance, first issued in August 1999 and subsequently updated, includes, among other things, deferral of donors who visited or resided in Europe where BSE prevalence is higher than in the US. Also, blood components and plasma derivatives are to be withdrawn if a donor is later diagnosed with vCJD. The potential spread of vCJD through red blood cell or plasma transfusion is limited by these deferral and quarantine measures that are in place.
  • Additional steps FDA is taking to reduce potential vCJD risk from plasma derivatives include gathering, evaluating, and disseminating information about manufacturing processes that potentially could reduce the vCJD infectious agent in blood products. FDA is helping to develop donor screening and diagnostic tests for vCJD, and to inform patients and physicians about the current scientific understanding of vCJD risk from blood products.
  • Using a computer model, FDA assessed the potential risk of vCJD infection from the current use of pdFVIII products. However, because so much is unknown about vCJD and its prevalence, the risk assessment performed by FDA has a lot of uncertainty, making it impossible to precisely estimate the risk of vCJD in general, or of the actual risk to individual hemophilia A or von Willebrand disease patients. Meaningful distinctions also could not be made among specific products. There is no test yet available to detect vCJD infection in healthy donors or recipients.
  • Although the risk of vCJD exposure from US pdFVIII products is most likely to be extremely small, it may not be zero, and FDA is encouraging physicians and patients to consider this risk, in the context of all remaining real or potential risks and the known benefits of product use, when making treatment decisions.
  • At this time, the PHS does not believe there is a need for hemophilia A and von Willebrand disease patients who receive pdFVIII to inform their surgeons or dentists about their potential exposure to vCJD. Also, there is no recommendation for surgeons and dentists to take any special precautions based on such potential exposures. This belief is based on the results of the FDA risk assessment, as well as on the lack of known cases of vCJD transmitted by plasma-derived clotting factor products in the UK or anywhere else in the world. PHS agencies will continue to monitor and reevaluate the situation as new information becomes available.
  • vCJD originally came from a disease in cattle called “mad cow disease” or BSE (bovine spongiform encephalopathy) . Transmission of the BSE agent to humans, leading to vCJD, is believed to occur primarily from eating beef and beef products contaminated with the BSE agent. Both BSE and vCJD are invariably fatal brain diseases with incubation periods typically measured in years.
  • From 1995 through April 2007, 202 individuals with vCJD were reported worldwide, with 165 in the United Kingdom (UK), and three in the United States. Two of the individuals in the United States had lived in the UK from 1980-1996 during a key exposure period to the BSE agent. The third US individual with vCJD most likely acquired the disease in Saudi Arabia. The reported incidence of vCJD in the UK based on disease onset peaked in 1999 and has been declining thereafter. In the UK, where most cases of vCJD have occurred, the current risk of acquiring vCJD from eating beef and beef products appears to be negligible.
  • More information about vCJD is available on these government websites:
  • Information also may be obtained from these non-government sources:
    • Committee of Ten Thousand
    • Hemophilia Federation of America
    • National Hemophilia Foundation and/or HANDI
    • World Federation of Hemophilia
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