Blood Donor Restrictions Urged for Former U.K. Visitors

FDA Consumer, Nov, 1999

Certain former visitors to the United Kingdom should not be blood donors in the United States, according to a new guidance issued by FDA.

The new restrictions, issued in August, are a precautionary step designed to reduce the theoretical risk of transmitting a fatal degenerative disease called new variant Creutzfeldt-Jakob disease (nvCJD). The disease has been linked to the disease bovine spongiform encephalopathy, often referred to in the popular press as BSE or "mad-cow disease."

New variant CJD has been found almost exclusively in the United Kingdom, which includes England, Scotland, Wales, Northern Ireland, the Isle of Man, and the Channel Islands. No cases of BSE or nvCJD have been identified in the United States.

FDA's guidance to blood establishments (like a similar guidance issued by Canada's health ministry) asks blood centers to exclude potential donors who have spent six or more cumulative months in the United Kingdom between Jan. 1, 1980, and Dec. 31, 1996. Also excluded are donors who have received non-U.S.-licensed insulin from cows or other injectable products made from cattle in countries with documented cases of BSE.

While no evidence exists to suggest that nvCJD can be transmitted by blood, blood products, or injectable products made from cattle, studies are under way to evaluate these possibilities.

FDA's new guidance also will no longer recommend that blood centers withdraw from use plasma derivatives from donors at risk for or who have been diagnosed with classic CJD, which has not been found to be transmitted by blood or blood products. The agency's previous guidance recommended that blood centers permanently defer these donors and that the blood centers immediately retrieve, quarantine and destroy any blood products or plasma derivatives from them.

FDA expects blood centers to implement the guidance by early 2000. For a complete copy of the guidance, go to www.fda.gov/cber/guidelines.htm on FDA's Website.