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Monday 11 June 2012

ANTIDEPRESSANTS : SSRIs for children and young people : the black box warning provides additional information with an elaborate warnings section subtitled, clinical worsening and suicide risk, which contains the following statement: antidepressants - black box warning ; pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (mdd) and other psychiatric disorders.

Suicidality and Antidepressant Drugs


Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. …

The Black Box Warning provides additional information with an elaborate WARNINGS section subtitled, Clinical Worsening and Suicide Risk, which contains the following statement:

Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders.
This section continues with a specific warning about the increased risk of medication-induced suicidality during “the initial few months of a course of drug therapy, or at times of doses changes, either increases or decreases.”  It then describes an activation or stimulant-like array of adverse effects:
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility aggressiveness, impulsivity, akathisia (psychomotor restlessness), 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.
Note the specific mention of “irritability, hostility, aggressiveness, impulsivity”­a virtual prescription for causing suicide and violence, especially in an already stressed individuals, including soldiers.  In a rare display of emphasis by the FDA, this array of dangerous symptoms is described several times more in the label.

Under the heading Information for Patients the label addresses the importance of informing patients about all of these risks. The probability that these warnings will be given to military personnel is not high, and of course their families will often be unavailable to monitor them.

A Medication Guide for all age groups appears at the end of the label. The label states, “The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.”  The Medication Guide lists the following risks associated with the drugs.

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Once again note the array of dangerous adverse reactions, including not only suicide but many emotional and behavior reactions that would be especially hazardous in a soldier, including, “feeling very agitated or restless,” “new or worse irritability,” “acting aggressive, being angry, or violent,” and “acting on dangerous impulses “

II. Overview of Scientific Studies

A. Antidepressant-Induced Suicidality in Children and Adults

In addition to the studies done under the auspices of the FDA (above), a large body of research confirms an increased risk of suicidality in children and adults (of all ages) when taking antidepressants.  Aursnes et al. (2005) located 16 placebo-controlled clinical trials in which Paxil had been randomized against placebo and found increased suicidal behavior. Fergusson et al. (2005) searched the adult literature and found 702 randomized clinical trials (87,650 patients) and found a significant increase in suicidality on antidepressants. Donovan et al. (1999) in a large British study involving 222 suicides found a higher rate of suicide on patients treated with the newer antidepressants. Donovan et al. (2000) examined 2776 consecutive cases of deliberate self-harm in individuals age seventeen and older seen at the emergency department of a British infirmary. Again, suicide attempt rates were higher among patients treated with newer antidepressants. Jick et al. (1995) conducted an epidemiological study in the United Kingdom involving 172,598 adult patients and Prozac was associated with more suicides than the older antidepressants. Frankenfield et al. (1994) studied coroner’s cases in Maryland and found the suicides were more violent in patients taking Prozac compared to older antidepressants.

GlaxoSmithKline (2006) conducted a new meta-analysis of all of its adult trials of Paxil and found an increased rate of suicidality in depressed patients of all ages. .

A study of 1,255 suicides in 2006 in Sweden (95 percent of all suicides in the country)  reported that 32 percent of Scandinavian men and 52 percent of Scandinavian women filled a prescription for antidepressants in the 180 days prior to suicide ((Ljung et al., 2009).  A retrospective study examined the suicide rates among 887,859 VA patients treated for depression and found that “completed suicide rates were approximately twice the base rate following antidepressant starts in VA clinical settings” (Valenstein et al., 2009).

Juurlink et al. (2006) reviewed more than 1,000 cases of actual suicides in the elderly and found that during the first month of treatment the SSRI antidepressants were associated with nearly a five-fold higher risk compared to other antidepressants.  Fisher, Kent and Bryant (1995) conducted a phone survey of pharmacy patients taking various antidepressants and found a higher rate of suicidality on SSRIs.

The studies in this section confirm that the risk of antidepressant suicidality is not limited to children, youth, and young adults, but encompasses all ages.

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