Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

Abstract

Serious adverse drug events (ADEs) are an important public health problem whose dimensions have been imprecisely defined. Serious ADEs have been estimated to account for 3.1% to 6.2% of admissions to hospitals studied.¹ Among hospital inpatients, serious ADEs have been reported to occur at a rate of 1.9 per 100 admissions.² In hospital emergency departments, ADEs of all levels of severity were estimated to account for 2.5% of all visits for unintentional injury in 2005-2006, of which 16.7% were severe enough to require hospitalization.³ A meta-analysis of inpatient hospital and hospital admission studies conducted over several decades estimated that ADEs were associated with 106 000 deaths in 1994.¹