Adverse reactions to human serum albumin.

Objective: To describe the adverse effects associated with human serum albumin (HSA) administration.

Data Sources: A MEDLINE search and bibliography scanning were used to identify pertinent review articles, clinical studies, and case reports.

Study Selection: Emphasis was placed on reporting the results of human studies with the primary objective of investigating adverse effects attributable to HSA administration. Clinical trials that reported the occurrence of adverse effects possibly associated with HSA were also reviewed. Animal data were included where pertinent.

Data Extraction: Although isolated case reports were reviewed, data were primarily extracted from human studies involving large series of patients or studies that were randomized and prospective in nature.

Data Synthesis: Alterations in coagulation, renal, cardiovascular, and pulmonary functions were identified as potential adverse effects following the administration of HSA. Occurrences of hypersensitivity reactions, trace metal loading, and serum amino acid alterations associated with these infusions were also noted and are described here. Pulmonary and cardiovascular systems appear to be particularly prone to complications from excessive HSA administration. Adverse effects such as HSA-induced hypersensitivity reactions may be severe, but occur infrequently.

Conclusions: Controlled studies involving large numbers of patients are not currently available for an accurate assessment of the incidence of adverse effects attributable to HSA administration. Many of the reported reactions appear to be extensions of albumin's pharmacologic activities and would be expected to worsen following large doses of HSA.