AAP News Vol. 14 No. 10 October 1998, p. 15
© 1998 American Academy of Pediatrics
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Exercise discretion in albumin, PPF use in critically ill: FDA

The Food and Drug Administration (FDA), in response to a recent study, is urging physicians to exercise discretion in use of albumin and plasma protein fraction (PPF).

In a recent letter to physicians, David Feigal, M.D., M.P.H., medical deputy director, Center for Biologics, Evaluation and Research, alerted physicians to a review and commentary in the July 25 British Medical Journal (BMJ 1998; 317:235-240 and 317:0, 317:223, 317:240, 317:277 et seq). The articles, editorials and letters call into question the medical benefit of administration of albumin or PPF to seriously ill patients. The study's authors concluded that albumin should not be given to critically ill patients outside of rigorously conducted, randomized controlled trials.