05/20/2005

FDA considers albumin safe for use in critically ill patients with trauma or sepsis, based on their review of additional safety data and recommendations made by the Blood Products Advisory Committee. In a 1998 letter to healthcare professionals, the FDA had expressed concern about an apparent increase in mortality with albumin compared with crystalloid, based on a meta-analysis of currently-available literature. However, a large 2004 study found no increase in mortality in critically ill patients with trauma or sepsis given albumin. The safety of albumin in burn patients remains unknown as these patients were excluded from the 2004 study.

Further details can be found online at the following links:

• www.fda.gov/medwatch/SAFETY/2005/safety05.htm#albumin – 2005 FDA MedWatch safety alert
• www.fda.gov/cber/infosheets/albsaf051605.htm – 2005 FDA Information sheet
• www.fda.gov/cber/ltr/albumin.htm – 1998 letter to Healthcare Providers