On Monday, November 27th, the Food and Drug Administration (FDA) released documents relating to the Agency’s assessment of the risk of acquiring variant Creutzfeld-Jakob Disease (vCJD), a human form of mad cow disease, for persons with bleeding disorders who have used US licensed plasma-derived factor VIII products (pdFVIII). Although there are still too many uncertainties to allow the Agency to make a precise calculation of theoretical risk without further study of this issue, FDA officials and other experts continue to believe that this risk is exceedingly low but possibly not zero. It is important to note that there have been no known cases of vCJD in users of pdFVIII products worldwide, including in the United Kingdom where the prevalence of vCJD in the general population is the highest in the world.
On December 15, the agency will convene a panel of consumers, medical professionals and other experts to advise them on how best to broadly communicate this information to the public. NHF will participate on the panel, and will continue to work closely with the FDA and other government agencies to ensure that the community receives complete, accurate and timely information on this subject.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. The CDC will convene a call for HTC Directors on Friday – more information to follow.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The System is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge.
To enroll in the PNS, please go online at http://www.patientnotificationsystem.org/
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommend that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.