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Safety of human albumin based on spontaneously reported serious adverse events

von Hoegen, Ilka PhD; Waller, Charles

Clinical Investigations

Objective To evaluate the safety of human albumin administered for therapeutic purposes.

Design Retrospective compilation of spontaneously reported serious adverse events.

Setting Records of serious adverse event reports received from 1990 through 1997 by nine major suppliers of therapeutic human albumin worldwide.

Patients Primarily hospitalized patients.

Interventions Administration of human albumin.

Measurements and Main Results  The number of 40-g doses distributed by the nine suppliers during the study period was 95.4 × 106, corresponding to 3.82 × 106 kg albumin, and reported serious adverse events totaled 123. The incidence of all serious adverse events was 1.29 per 106 doses (95% confidence interval, 1.07 per 106 to 1.54 per 106 doses). No patient death was judged to be probably attributable to albumin administration. The incidence of fatal serious adverse events possibly related to albumin was 5.24 per 108 doses (95% confidence interval, 1.70 per 108 to 12.24 per 108 doses).

Conclusions Although underreporting must be recognized as a limitation of spontaneous adverse event reports, this study encompassing approximately 100 million albumin doses provides evidence that both nonfatal and fatal serious adverse events in albumin recipients are very rare. These results provide further support for the excellent long-term safety record of human albumin.

From the Plasma Protein Therapeutics Association, Brussels, Belgium.

Address requests for reprints to: Ilka von Hoegen, PhD, Plasma Protein Therapeutics Association, Boulevard Brand Whitlock, 114/5, 1200 Brussels, Belgium. E-mail:

© 2001 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins