Safety of human albumin—serious adverse events reported worldwide in 1998–2000 † †Declaration of interest. This investigation was supported by an unrestricted grant from the Plasma Protein Therapeutics Association. The sponsor played no role in the analysis and interpretation of data or the preparation and submission of the manuscript. Hygeia Associates is an independent organization specializing in the statistical analysis of biomedical research data and is in no way affiliated with the sponsor, either directly or indirectly. None of the co-investigators in this study has any conflict of interest to declare.

Abstract

Previous pharmacovigilance studies have indicated a low rate of adverse events in patients receiving human albumin. However, the incidence of adverse events is likely to have been underestimated because of under-reporting. A more accurate estimate may be possible during a period such as 1998-2000, when awareness regarding albumin safety was heightened by publication of a meta-analysis. All serious adverse event reports received, and total doses of albumin distributed worldwide from the beginning of 1998 to the end of 2000 by 10 major suppliers of therapeutic human albumin were compiled. Distributed albumin doses totalled 1.62 x 10(7). The total numbers of non-fatal and fatal serious adverse events reported were 198 and 13, respectively. The incidence of all reported serious non-fatal and fatal adverse events was 5.28 per 10(6) doses (CI 1.60-17.4 per 10(6) doses). For non-fatal serious adverse events only, the observed incidence was 4.65 per 10(6) doses (CI 1.34-16.2 per 10(6) doses). No patient death was classified as probably related to albumin administration. The observed incidence of fatal serious adverse events possibly related to albumin was 0.185 per 10(6) doses (CI 0.0597-0.574 per 10(6) doses). The observed incidence of all non-fatal and fatal serious adverse events was significantly higher during the 1998-2000 period as compared with 1990-1997 (incidence rate ratio 4.98; CI 3.94-6.29), probably chiefly as a result of reduced under-reporting. Although the observed incidence of adverse events is likely to be an underestimate, nevertheless both non-fatal and fatal serious adverse events in albumin recipients appear to be rare. These results add further support to the excellent safety record of human albumin.