Safety of human albumin based on spontaneously reported serious adverse events

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ObjectiveTo evaluate the safety of human albumin administered for therapeutic purposes.DesignRetrospective compilation of spontaneously reported serious adverse events.SettingRecords of serious adverse event reports received from 1990 through 1997 by nine major suppliers of therapeutic human albumin worldwide.PatientsPrimarily hospitalized patients.InterventionsAdministration 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).ConclusionsAlthough 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.

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