V. I. Technologies' PLAS+SD Plasma Substitute Linked to Six Patient Deaths
- V.I. Technologies' PLAS+SD Plasma Substitute Linked to
Six Patient Deaths
WASHINGTON (Reuters Health) Oct 24 - Six patients
undergoing liver transplantation have died after
receiving V.I. Technologies' PLAS+SD, the company said
in a recently issued Dear Healthcare Provider letter.
PLAS (pooled plasma, [human] solvent detergent
treated), which is analogous to fresh frozen plasma,
is indicated to control bleeding during extensive
medical procedures and for use in patients with
chronic liver disease or certain genetic clotting
"We have received reports of serious adverse events
occurring in a cluster of six patients, who underwent
orthotopic liver transplantation for end stage liver
disease due to a variety of underlying disease
processes," V.I. Technologies said in the letter.
All six patients received intra-operative PLAS along
with other blood products and all died "due to
thrombotic events or excessive bleeding during the
All six deaths occurred at a single institution.
"In cooperation with [the US Centers for Disease
Control and Prevention] and the US Food and Drug
Administration, [V.I. Technologies] has issued a
warning letter to doctors that those individuals who
undergo liver transplantation should be carefully
monitored when PLAS+ is used in this setting," Dr.
Fred Darr, director of medical affairs for plasma
services of the American Red Cross, which distributes
the product for V.I. Technologies, told Reuters
"However, patients should also be closely monitored
when fresh frozen plasma is used for this indication,"
V.I. Technologies claims that PLAS+SD is the only
virally inactivated plasma substitute in the US. Fresh
frozen plasma is tested for viruses but does not go
through any viral inactivation procedures, Dr. Darr
The company is investigating any potential role PLAS
may have played in the deaths. "Until the
investigation has concluded, we ask that caution be
exercised when using PLAS," V.I. Technologies said in
The company advised physicians to carefully monitor
the coagulation status of liver transplant patients in
whom they plan to use PLAS.
The Red Cross' sales force is alerting physicians of
the deaths and the need for closer patient monitoring,
Dr. Darr said. In addition, all transplant centers in
the US, blood banks and customers who have used the
product have been notified of the deaths.
Dr. Darr noted that the nationwide mortality rate for
liver transplantations is expected to be 20% while the
center where these six deaths occurred has a mortality
rate of 18%. He declined to give the name of the
No further deaths in patients administered PLAS have
been reported since the initial six, Dr. Darr said.
The product is also distributed in Canada, and no
deaths have been reported there, he added.
V.I. Technologies also notes in the letter that it has
received reports of various particulates, including
large, opaque protein aggregates and translucent
clots, in thawed PLAS.
This "may be related to improper handling or storage
of the product," V.I. Technologies said in the letter.
"FDA wanted us to emphasize the proper way to store
the product, how to handle it and how to thaw it," Dr.
Darr said. He characterized the storage problems as a
V.I. Technologies did not return phone calls from
Reuters Health on Monday
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