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Medical Advisory #403: vCJD Risk Announced for German and Italian users for ZLB product

January 18, 2005

The National Hemophilia Foundation (NHF) has been notified by ZLB Behring that a single lot of hemophilia clotting factor manufactured in 1996 by its predecessor company, Centeon, has been linked to a French donor who later developed variant Creutzfeldt-Jakob Disease (vCJD). The implicated lot (number 5676641) was marketed and sold under the brand name Haemate® HS 1000 in Germany and Haemate® P 1000 in Italy. According to ZLB, the lot was recalled in 1997 for reasons not related to the incidence of vCJD, but a majority of the lot was not returned. ZLB made the discovery during a self-initiated look-back following the announcement regarding the French donor.

ZLB’s U.S. product, Humate P®, is manufactured exclusively from U.S. donor plasma and, according to ZLB, is not affected by this announcement. To date, no cases of vCJD are known to have been transmitted by any plasma product. However, anyone who suspects they may have used product with the lot number above, anyone who lived in Germany or Italy in the late 1990’s and used Haemate® HS 1000 or Haemate® P 1000, and anyone who imported either of these products into the United States for compassionate or personal use should contact their hemophilia treatment center.

NHF continues to investigate all instances of plasma donations from donors later determined to have vCJD. While the potential for vCJD transmission through plasma products and derivatives is presumed to be low, the U.S. Food and Drug Administration (FDA) has not approved any manufacturing claim that the production process for any plasma-based coagulation product eliminates the risk of vCJD transmission. NHF will continue to disseminate updated and new information as it becomes available.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

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.