http://www.nytimes.com/aponline/national/AP-Plasma-Deaths.html

Fatal Blood Plasma Warning Issued

By THE ASSOCIATED PRESS

Filed at 12:31 p.m. ET

WASHINGTON (AP) -- The government is warning against use of a type of plasma in certain liver patients -- years after the first deaths linked to the product. Few hospitals even have any of the plasma left to use.

At issue is ``solvent-detergent plasma,'' made by Massachusetts-based V.I. Technologies and distributed by the American Red Cross.

Six liver transplant patients who received SD plasma at Los Angeles' Cedars-Sinai Medical Center died between April and December 1999. The Food and Drug Administration investigated and couldn't conclude if the plasma was to blame. The patients were very ill to begin with, and one European study of SD plasma in liver transplants suggested it was safe.

Still, the agency pushed V.I. Technologies to write doctors nationwide in October 2000, advising them of the deaths and urging caution in using the plasma.

Between August 2000 and March 2001, the FDA learned of four more deaths. In an unusual move, FDA officials refuse to reveal where they occurred.

FDA again found no proof the plasma was to blame, but came up with a theory: Because the plasma's processing stripped out certain proteins involved in blood clotting, it might spur either clots or bleeding in people whose liver disease predisposed them to one or the other conditions, explained FDA hematology director Dr. Mark Weinstein.

So FDA took the precaution of adding a warning to the plasma, telling doctors not to use it during liver transplants or on patients with severe liver disease.

FDA quietly issued the warning in late March, and made it public Thursday night after Newsday uncovered it. But ironically, the decision comes after V.I. Technologies quit making SD plasma last year, and few hospitals have much supply left.

Why the delay? ``I can only say this is a very difficult area to assess,'' Weinstein said.

SD plasma was long controversial. Traditionally, doctors infuse plasma taken from one donor and tested for infection. SD plasma is pooled from many donors and run through a cleansing process designed to remove certain viruses that testing might have been missed. It's much more expensive, and some blood safety experts say the risk of pooling donors offsets any cleansing advantage.

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