Format

Send to

Choose Destination
See comment in PubMed Commons below
PLoS One. 2010 Dec 15;5(12):e15337. doi: 10.1371/journal.pone.0015337.

Prescription drugs associated with reports of violence towards others.

Author information

  • 1Institute for Safe Medication Practices, Alexandria, Virginia, United States of America. tmoore@ismp.org

Abstract

CONTEXT:

Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.

OBJECTIVE:

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.

METHODOLOGY:

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.

MAIN OUTCOME MEASURES:

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<0.01).

RESULTS:

We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.

CONCLUSIONS:

Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.

PMID:
21179515
PMCID:
PMC3002271
DOI:
10.1371/journal.pone.0015337
[PubMed - indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Public Library of Science Icon for PubMed Central
    Loading ...
    Support Center