USA. The United States Food and Drug Administration (FDA) has revised its previous advice on the safety of albumin administration to patients who are critically ill, following a review of recent studies. In 1998, following the publication of a meta-analysis by the Cochrane Injuries Group, the FDA had expressed 'serious concern' about the safety of albumin administration to patients who were critically ill. The study had found that the relative risk of dying was higher with albumin than with normal saline administration in such patients; the findings were similar for patients with hypovolaemia, burns and hypoproteinaemia. In March 2005, the Blood Products Advisory Committee (BPAC) voted that the results of a randomised controlled trial (the SAFE study: Saline versus Albumin Fluid Evaluation, N Engl J Med 2004;350:2247-56), resolved the prior safety concerns raised in the Cochrane meta-analysis; in the SAFE study, the mortality rate for patients in the general ICU population was the same for those who received albumin as for those who received saline for fluid resuscitation. The FDA states that the revision of its advice is consistent with the BPAC recommendations. However, as patients with burns were excluded from the SAFE study, the relative safety of albumin cannot be determined for this group.

Reference:

Safety of albumin administration in critically ill patients. United States Food and Drug Administration, 16 May 2005 (http://www.fda.gov).