United States of America. The Food and Drug Administration has drawn attention to an article that calls into question the medical benefit of albumin or plasma protein fraction administration to seriously ill patients.
A meta-analysis of virtually all existing randomized, controlled clinical studies of albumin or plasma protein fraction revealed excess mortality of approximately 6% for combined groups of patients with hypovolaemia, burns or hypoproteinaemia who received albumin either instead of or in addition to crystalloid solutions. On the basis of their analysis, the authors concluded that albumin should not be given to critically ill patients outside of rigorously conducted randomized controlled trials.
The FDA considers that the questions raised in these studies warrant serious consideration and until the results of further studies are available, physicians should exercise discretion in using albumin and plasma protein fraction. The importance of current treatment guidelines is stressed, although it is recognized that these guidelines may themselves require change.
1) “Dear Doctor” letter from the Centre of Biologics Evaluation and Research, FDA [http://www.fda.gov/medwatch/safety/1998/plasma.htm].
2) Cochrane Injuries Group Albumin Reviewers. Human albumin administration in critically ill patients: systematic review of randomised controlled trials. British Medical Journal 317: 235-240 and 223, 277 (1998).
3) ISMP Medication Safety Alert! Vol. 3, Issue 18, 9 September 1998.