Reactions 980 - 6 Dec 2003 Human albumin: serious adverse events rare Serious adverse events associated with human albumin administration appear to be rare, according to researchers from the US. Using pharmacovigilance data obtained from ten major suppliers of human albumin, the researchers determined the incidence of serious fatal and nonfatal adverse events associated with its use from the beginning of 1998 to the end of 2000. During this time, the quantity of human albumin distributed worldwide by the ten companies totalled 1.62 × 10 7 40g doses. The combined total numbers of nonfatal and fatal adverse events spontaneously reported to the ten companies were 198 and 13, respectively. Of the nonfatal adverse events, 7.1% were classified as probably related to albumin and the remainder were possible, unrelated or unknown. Three fatalities were classified as possibly related to albumin and the remainder were judged unrelated; none were classified as probably related. The observed incidence of all serious adverse events was 5.28 per 10 6 doses (95% CI 1.6–17.4 per 10 6 doses) and for nonfatal adverse events only was 4.65 per 10 6 doses (1.34–16.2). The researchers note that the incidence of all serious adverse events reported for 1998–2000 was approximately 5-fold higher than reported for 1990–1997, probably reflecting heightened awareness of possible excess mortality associated with albumin, but conclude that both nonfatal and fatal adverse events still appear to be rare. Vincent J-L, et al. Safety of human albumin-serious adverse events reported worldwide in 1998-2000. British Journal of Anaesthesia 91: 625-630, No. 5, Nov 2003 800964766 1 Reactions 6 Dec 2003 No. 980 0114-9954/10/0980-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Human albumin: serious adverse events rare

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Reactions 980 - 6 Dec 2003

Human albumin: serious adverseevents rare

Serious adverse events associated with humanalbumin administration appear to be rare, according toresearchers from the US.

Using pharmacovigilance data obtained from tenmajor suppliers of human albumin, the researchersdetermined the incidence of serious fatal and nonfataladverse events associated with its use from thebeginning of 1998 to the end of 2000. During this time,the quantity of human albumin distributed worldwide bythe ten companies totalled 1.62 × 107 40g doses. Thecombined total numbers of nonfatal and fatal adverseevents spontaneously reported to the ten companieswere 198 and 13, respectively. Of the nonfatal adverseevents, 7.1% were classified as probably related toalbumin and the remainder were possible, unrelated orunknown. Three fatalities were classified as possiblyrelated to albumin and the remainder were judgedunrelated; none were classified as probably related. Theobserved incidence of all serious adverse events was5.28 per 106 doses (95% CI 1.6–17.4 per 106 doses) andfor nonfatal adverse events only was 4.65 per 106 doses(1.34–16.2).

The researchers note that the incidence of all seriousadverse events reported for 1998–2000 wasapproximately 5-fold higher than reported for1990–1997, probably reflecting heightened awarenessof possible excess mortality associated with albumin,but conclude that both nonfatal and fatal adverse eventsstill appear to be rare.Vincent J-L, et al. Safety of human albumin-serious adverse events reportedworldwide in 1998-2000. British Journal of Anaesthesia 91: 625-630, No. 5, Nov2003 800964766