FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-25                         Print Media:         301-827-6242 
May 6, 1998                    
                               Consumer Inquiries:  800-532-4440

FDA APPROVES ALTERNATIVE TO FRESH FROZEN PLASMA

FDA today approved a virally inactivated, processed blood product manufactured from pooled human plasma that can serve as an alternative to fresh frozen plasma. The manufacturing process for this new product includes a solvent detergent procedure that inactivates some blood-borne viruses such as the human immunodeficiency virus (HIV, the AIDS virus), hepatitis B (HBV) and hepatitis C (HCV). This procedure is similar to ones used to inactivate viruses in numerous more extensively processed plasma-derived products, including some clotting factors used to treat hemophiliacs.

The new product, often referred to as SD plasma, is administered intravenously. Like fresh frozen plasma, it is approved for a limited number of conditions such as the treatment of various clotting disorders, a rare condition known as TTP, and bleeding related to the use of the drug warfarin (a so-called blood thinner).

Donors of pooled plasma used to manufacture SD plasma, like all blood donors, are screened to help exclude those who are infected with any of several blood-borne disease agents, including HIV, HBV, and HCV. However, current testing methods, while extremely effective, do not always detect early infections.

Both SD plasma and fresh frozen plasma are manufactured with overlapping safeguards that result in effective, safe products. However, they have different safety profiles.

On one hand, SD plasma is manufactured with a viral inactivation step that effectively eliminates viruses with a lipid envelope such as HIV, HBV, and HCV viruses, that may have been undetected through donor screening.

On the other hand, fresh frozen plasma is obtained from single donors, rather than pooled from a few thousand donors. Viruses without lipid envelopes are not inactivated by SD treatment. Because fresh frozen plasma is not pooled, there may be less risk from these viruses, as well as from unknown agents, than with a pooled product.

The new product is manufactured by V.I. Technologies, Inc., Melville, New York with the trade-name VIPLAS/SD. The company has a contract with the American Red Cross to distribute it.

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