RT Journal
A1 Weiss-Smith S, Deshpande G, Chung S, Gogolak V
T1 The fda drug safety surveillance program: Adverse event reporting trends
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2011
FD March 28
VO 171
IS 6
SP 591
OP 593
DO 10.1001/archinternmed.2011.89
UL http://dx.doi.org/10.1001/archinternmed.2011.89
AB 
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.