Friday, March 04, 2011

Psychiatric Drugs and Violence: A Review of FDA Data Finds A Link

Mad in America

History, Science, and the Treatment of Psychiatric Disorders

by Robert Whitaker

Psychiatric Drugs and Violence: A Review of FDA Data Finds A Link

Antidepressants near top of list of drugs associated with violence

There has been an enduring controversy over whether psychiatric medications can trigger violent actions toward others. A review of the FDA's Adverse Event Reporting System  by Thomas Moore, Joseph Glenmullen and Curt Furberg, which was published by PLoS One on December 15, found that such "adverse events" are indeed associated with antidepressants and several other types of psychotropic medications.

To do their study, Moore and his collaborators extracted all serious events reports from the FDA's database from 2004 through September 2009, and then identified 484 drugs that had triggered at least 200 case reports of serious adverse events (of any type) during that 69-month period. They then investigated to see if any of these 484 drugs had a "disproportionate" association with violence. They identified 31 such drugs, out of the 484, that met this criteria.

The 31 "suspect" drugs accounted for 1527 of the 1937 case reports of violence toward others in the FDA database for that 69-month period. The drugs in that list of 31 included varenicline (an aid to smoking cessation), 11 antidepressants, 6 hypnotic/sedatives, and 3 drugs for attention deficit hyperactivity disorder. Antidepressants were responsible for 572 case reports of violence toward others; the three ADHD drugs for 108; and the hypnotic/sedatives for 97.

Of the 1937 total case reports of violence toward others, there were 387 cases of homicide, 404 physical assaults, 27 cases of physical abuse, 896 reports of homicidal ideation, and 223 cases of "violence related symptoms."

The adverse events reported to the FDA are known to represent but a tiny fraction of all such adverse events. This study simply identified 31 drugs responsible for most of the FDA case reports of violence toward others, with antidepressants near the top of that list.

In light of this finding, the many past shootings at school campuses and other public venues should perhaps be investigated anew by government officials, with an eye toward ascertaining whether psychotropic use may have, in the manner of an adverse event, triggered that violence.

Moore and his collaborators concluded: "These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and serotonin reuptake inhibitors were the most strongly and consistently implicated drugs."

 

And more here:

 

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015337

Prescription Drugs Associated with Reports of Violence Towards Others

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<0.01).

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.

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.

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