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V. I. Technologies' PLAS+SD Plasma Substitute Linked to Six Patient Deaths

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  • claudine intexas
    V.I. Technologies PLAS+SD Plasma Substitute Linked to Six Patient Deaths ... WASHINGTON (Reuters Health) Oct 24 - Six patients undergoing liver
    Message 1 of 1 , Oct 29, 2000
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      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
      factor deficiencies.

      "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
      transplant procedure."

      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
      Health.

      "However, patients should also be closely monitored
      when fresh frozen plasma is used for this indication,"
      he added.

      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
      said.

      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 letter.

      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
      center.

      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
      minor issue.

      V.I. Technologies did not return phone calls from
      Reuters Health on Monday


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