TY  - JOUR
T1  - The fda drug safety surveillance program: Adverse event reporting trends
AU  - Weiss-Smith S, Deshpande G, Chung S, Gogolak V
Y1  - 2011/03/28
N1  - 10.1001/archinternmed.2011.89
JO  - Archives of Internal Medicine
SP  - 591
EP  - 593
VL  - 171
IS  - 6
N2  - 
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.

SN  - 0003-9926
M3  - doi: 10.1001/archinternmed.2011.89
UR  - http://dx.doi.org/10.1001/archinternmed.2011.89
ER  -