Selective serotonin reuptake inhibitors antidepressants and risk of violen...( episodes associated with paroxetine t...),Health

A summary of placebo controlled trials in children and adults showed that 60 of 9219 (0.65%) patients given paroxetine, compared with 20 of 6,455 given placebo (0.31%) had what was called a "hostility event".

In their submissions to the Committee on Safety of Medicines Expert Working Group, GlaxoSmithKline reported 44 hostile events in 11,491 patients taking paroxetine in trials comparing paroxetine with other antidepressants (i.e. 0.38% of all patients taking paroxetine experienced a hostile event). In a subset of trials comparing paroxetine with another SSRI, there were 16 hostile events among all 2,418 patients taking paroxetine (0.66%). In healthy volunteer studies, in which paroxetine was given to people who were healthy, hostile events occurred in three of 271 (1.1%) volunteers taking paroxetine, compared with zero in 138 taking placebo. GlaxoSmithKline ascribed these episodes in the healthy volunteers to the fact that the volunteers were confined in a clinical trials centre, although this applied to both the volunteers taking paroxetine and those taking placebo. One other healthy volunteer study had previously reported aggressive behaviour in one volunteer taking sertraline.

In adverse drug event monitoring there were violent events in 56 of 13,741 (0. 41%) patients taking paroxetine and 60 in 12,692 patients ( 0.47%) taking fluoxetine. In the emails from 1,374 patients after the BBC programme the authors report that "Many linked emotional storms and thoughts and acts of violence or self-harm to paroxetine". Finally, the authors describe 9 illustrative medico legal cases in which they have been involved.

After reviewing the possible mechanisms for the violence associated with SSRIs, the authors conclude that: "The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where anti
'"/>

Contact: Andrew Hyde
press@plos.org
44-122-346-3330
Public Library of Science
11-Sep-2006