RT Journal
A1 Duke J, Friedlin J, Ryan P
T1 A quantitative analysis of adverse events and “overwarning” in drug labeling
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2011
FD May 23
VO 171
IS 10
SP 941
OP 954
DO 10.1001/archinternmed.2011.182
UL http://dx.doi.org/10.1001/archinternmed.2011.182
AB 
Product labeling is a primary source of drug safety information for physicians. However, the effectiveness of labeling in communicating adverse drug events (ADEs) may be diminished by the problem of “overwarning,” in which excessively long and complex lists of potential reactions can result in information overload.1- 2 The Food and Drug Administration (FDA) highlighted this issue in 2006 as they unveiled new labeling guidelines, specifically discouraging the inclusion of “exhaustive lists of every reported adverse event, no matter how infrequent or minor.”3- 4(p2) Yet, at present, there are no baseline data on overwarning, nor are there benchmarks against which the success of the FDA's interventions can be measured. The goal of our study was to address this gap by producing comprehensive quantitative data on ADE labeling patterns. We further sought to measure whether the 2006 guidelines were successful in reducing the burden of overwarning.