A SERVICE
OF 
PLAS+SD Use and
Liver Transplant Deaths Could be Linked
WATERTOWN, Mass.- November 1, 2000· by TNN Medical Reporter
Virginia Baskerville
- Health care providers should carefully monitor the coagulation
status of patients in whom the plasma product PLAS+SD is being used during
liver transplantation, says the product's maker, V.I. Technologies. According
to a "Dear Doctor/Healthcare Provider" letter by the company dated October 20,
six patients at a single institution who were receiving PLAS+SD (pooled plasma,
[human] solvent detergent treated) during orthotopic liver transplantation for
endstage liver disease died due to thrombotic events or excessive bleeding
during surgery. The letter was posted by the Food and Drug Administration's
MedWatch. "The possible relationship between the use of PLAD+SD and these
reported adverse events is currently under investigation," the letter reads.
"…we ask that caution be exercised when using PLAS+SD during liver
transplant procedures. If PLAS+SD is to be used during liver transplant, the
coagulation status of the patients should be carefully monitored for evidence
of thrombosis, excessive bleeding, or exacerbation of disseminated
intravascular coagulation." The letter also noted that there have been reports
of particulates of various types in thawed PLAS+SD, and it lists storage and
handling information for the product. Adverse events associated or possibly
associated with the use of PLAS+SD can be reported to INFOTRAC at
1-800-535-5053 or to the FDA's MedWatch Reporting System by phone at
1-800-FDA-1088; by fax at 1-800-FDA-0178; or by submitting Form 3500 online at
www.accessdata.FDA.gov/scripts/medwatch or by mail to
MedWatch, HF-2, 5600 Fisher's Lane, Rockville, MD 20852-9787. For Your
Information: To read the letter, click on "Posted 10/20/2000" at
www.fda.gov/medwatch/new.htm, or go to
www.fda.gov/medwatch/safety/2000/plassd.pdf.
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