Academic journal article Ethical Human Psychology and Psychiatry

Recent U.S., Canadian, and British Regulatory Agency Actions concerning Antidepressant-Induced Harm to Self and Others: A Review and Analysis

Academic journal article Ethical Human Psychology and Psychiatry

Recent U.S., Canadian, and British Regulatory Agency Actions concerning Antidepressant-Induced Harm to Self and Others: A Review and Analysis

Article excerpt

Drug regulatory agencies in the United States, Great Britain, and Canada have recently issued warnings concerning the use of antidepressants. Considerable attention has been placed on regulatory agency conclusions that antidepressants are associated with increased rates of suicidality in children. In the United States (the FDA) and Canada (Health Canada), new warnings have also been issued for children and adults concerning the production of an activation or stimulant syndrome that is known to be associated with violence and suicide. Health Canada requires a warning that selective serotonin inhibitors (SSRIs) and other newer antidepressants produce in children and adults "agitation-type adverse events coupled with self-harm or harm to other," including "akathisia (psychomotor restlessness), agitation, disinhibition, emotional lability, hostility, aggression, depersonalization." The FDA requires a warning that "The following symptoms; anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric." Recent studies confirm that antidepressants are associated with adverse events that can cause aggression, hostility, and violence, as well as suicidality, in both children and adults.

Keywords: Antidepressants; SSRIs; violence; FDA; labeling

Drug regulatory agencies in the United States (Food and Drug Administration [FDA]), Canada (Health Canada), and Great Britain (Medicines and Healthcare Products Regulatory Agency [MHRA]) have significantly upgraded their warnings concerning antidepressant-induced suicidality in children. Furthermore, the US and Canada have confirmed an antidepressant-induced stimulant or activation cluster of adverse events in children and adults that includes hostility and aggression. Although most attention has been given to warnings about drug-induced suicidality, more emphasis needs to be placed upon US and Canadian warnings about the potential production of stimulation and mania with hostility and aggression.

This report examines these recent regulatory events and related research. It also updates the author's most recent review of antidepressant-induced behavioral and mental abnormalities (Breggin, 2003).

The SSRIs (selective serotonin reuptake inhibitors) have been the major focus of attention by the regulatory agencies. With some exceptions in regard to the severity or frequency of adverse reactions, the SSRIs can be treated as one group in regard to their profile of adverse drug reactions.1 The SSRIs include fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), citalopram (Celexa) and escitalopram (Lexapro). In reports issued by the FDA (e.g., March 22, 2004) four other potentially stimulating antidepressants were found to produce similar adverse behavioral and mental effects and were included in the group: venlafaxine (Effexor), mirtazapine (Remeron), bupropion (Wellbutrin or Zyban), and nefazodone (Serzone).

RECENT RESEARCH FINDINGS

Fergusson and Colleagues Review Antidepressant-Induced Suicidality in Adults

In 2005 Fergusson and colleagues presented the most recent relevant scientific analysis of SSRI-induced suicidality in adults. The investigators reviewed all published randomized controlled clinical trials for these antidepressants through November 2004: a total of 702 trials. "Our systematic review, which included a total of 87,650 patients, documented an association between suicide attempts and the use of SSRIs. We also observed several methodological limitations in the published trials. A more accurate estimation of risks of suicide could be garnered from investigators fully disclosing all events." The odds ratio was 2.28 comparing SSRIs to placebo. This article bolstered the existing research on children and confirmed that the risk of antidepressant-induced suicidality in adults exists and is approximately equal to that in children. …

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