New plasma product offers alternative

FDA Consumer, Sept-Oct, 1998

An alternative to fresh frozen plasma is now available to treat various clotting disorders and other blood disorders, including a rare condition known as TTP and bleeding related to the use of the "blood thinner" drug warfarin.

SD plasma, approved May 6, is made from the pooled plasma of thousands of donors. The advantage of the pooled product is that it undergoes a solvent detergent procedure that inactivates some viruses, including hepatitis B and C and the human immunodeficiency virus, which causes AIDS. Current screening methods used on all blood donors do not always detect early infections.

The disadvantage of SD plasma is that pooling may increase the risk from other viruses that are not inactivated by SD treatment. Fresh frozen plasma comes from single donors.

However, both SD plasma and fresh frozen plasma are manufactured with overlapping safeguards that result in an effective, safe blood product.

SD plasma is manufactured by V.I. Technologies Inc., Melville, N.Y., under the trade name VIPLAS/SD. The company has a contract with the American Red Cross to distribute the product.