The FDA Drug Safety Surveillance Program: Adverse Event Reporting Trends

Abstract

The Adverse Event Reporting System (AERS) of the US Food and Drug Association (FDA) is the largest repository of passively reported adverse drug events in the world.¹ Approximately one-half million reports are received by the FDA annually. Designed as a safety net, allowing the FDA to monitor all marketed drugs and quickly detect serious safety problems, AERS reports have served as the basis for numerous regulatory actions.² In an 8-year period (1998-2005), the number of serious event reports increased 2.6-fold and reports of deaths increased 2.7-fold.³ Given the dramatic increase in adverse event reporting following the last major revision of the AERS database in 1997, we sought to characterize current reporting patterns.