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Albumin use in seriously ill patients

Executive Summary

"Albumin should not be given to critically ill patients outside of rigorously conducted, randomized, controlled trials," FDA declared in a "Dear Doctor" letter issued Aug. 25. An excess mortality of 6% was seen "for combined groups of patients with hypovolemia, burns, or hypoproteinemia who received albumin either instead of or in addition to crystalloid solutions," according to a meta-analysis performed by England's Cochrane Injuries Group, FDA states. The agency is "committed to working with the product manufacturers to determine whether the label indications for albumin and [plasma protein fraction] should be revised"
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PS032730

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