Albumin solutions--their production and quality control.

Analysis of all clinical reactions (complaints) reported to CSL in the past decade has revealed that "hypotension syndrome" continues to be the predominant side effect of infusion of albumin solutions. Although the incidence of clinical reactions to albumin solutions reported to CSL is approximately 1 in every 20,000 bottles issued, the virtual elimination of PKA from SPPS has not reduced the number of adverse clinical reports received by CSL. It is concluded that factors other than PKA contamination are responsible for hypotensive effects during or after infusion of albumin solutions. Other possible causes of "hypotension syndrome" are discussed.