Prescription Drugs Associated with Reports of Violence

December 15, 2010

Although reported on websites like SSRI Stories and AHRP, violent thoughts and acts towards others are widely reported occurrences that are rarely studied as adverse drug events.   Increased risk of suicidal behaviors—but not violence— associated with antidepressants has been examined through meta-analysis of clinical trials for approval by the U.S. Food and Drug Administration.  Despite limited clinical study, numerous drugs contain FDA-required warnings to doctors or patients about the possibility of aggressive or violent acts.

Among the drugs with warnings about aggressive behaviors are varenicline, zolpidem, montelukast, and all antidepressant drugs.   The mandatory patient Medication Guide for varenicline, the antidepressants and quetiapine warn patients to contact a healthcare provider immediately if they start “acting aggressive, being angry or violent.”

This study summarizes the evidence about reported acts of violence associated with therapeutic drugs among all serious adverse drug events reported to the FDA from 2004 through the third quarter of 2009.  (Full report here.)

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