title: Prescription drugs associated with reports of violence towards others.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Institute for Safe Medication Practices, Alexandria, Virginia, United States of America. tmoore@ismp.org
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Moore
authors.forename: Joseph
authors.initials: J
authors.lastname: Glenmullen
authors.forename: Curt D
authors.initials: CD
authors.lastname: Furberg
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000928:Antidepressive Agents / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D001552:Benzazepines / Q000009:adverse effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects; D017063:Outcome Assessment, Health Care; D004364:Pharmaceutical Preparations; D055553:Prescription Drugs / Q000009:adverse effects*; D011446:Prospective Studies; D011810:Quinoxalines / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration; D000068580:Varenicline; D014754:Violence
chemical_list: D000928:Antidepressive Agents; D001552:Benzazepines; D006993:Hypnotics and Sedatives; D004364:Pharmaceutical Preparations; D055553:Prescription Drugs; D011810:Quinoxalines; D000068580:Varenicline