By guest blogger Michael R. Cohen: President of the Institute for Safe Medication Practices
The link between violence and prescription drugs has rarely been studied. However, a study published last week in the journal PLoS ONE, identified 31 drugs that are disproportionally associated with reported cases of violence.
The study drew on reports of violence and aggression made to the Food and Drug Administration from 2004 through the third quarter of 2009. While far from definitive, these findings signal that more research is needed.
Leading the list in numbers of reports is the smoking cessation drug Chantix (varenicline).
Also associated with violence were psychoactive medications for depression (Prozac and Paxil), attention deficit disorder (Strattera) and sedative/hypnotic drugs.
The authors, Thomas J. Moore, a consulting senior scientist at the Institute for Safe Medication Practices, Joseph Glenmullen of Harvard Medical School and Curt D. Furberg of Wake Forest University School of Medicine, selected cases from the ISMP QuarterWatch database, composed of computer extracts of all adverse drug event reports received by FDA.
A violent event was defined as any case report mentioning homicide, physical assault, physical abuse, homicidal ideation or violence-related symptom.
For the five-year study period, the authors identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds. This total included 1,937 (0.25%) cases that met the violence criteria.
Thirty-one drugs met study criteria for a disproportionate association with violence, accounting for 1,527/1,937 (79%) of the violence cases.
Included were 387 reports of actual homicide, 404 that were physical assaults, 223 cases with violence-related symptoms and 896 homicidal ideation reports.
The prominence of Chantix was not a surprise. An association between that drug and serious psychiatric symptoms, including hostile behavior, was also a finding in a 2008 study by our group that looked at FDA adverse event reports in the fourth quarter of 2007. The authors of the present study had earlier linked Chantix to thoughts and acts of aggression/violence. The association also led FDA to require product label changes, including a boxed warning for the drug.
The authors conclude that their data “provide new evidence” that violent acts are “associated with a relatively small group of drugs” and that systematic studies “are needed to establish the incidence, confirm differences among drugs and identify additional common features.”
For information on ISMP's consumer web site go www.consumermedsafety.org
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