Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p