Suicidality in Children on Antidepressants ?

Q.The American College of Neuropsychopharmacology (ACNP) took a different stance after reviewing published and unpublished data from controlled trials of the antidepressants in children, in addition to epidemiological studies and autopsy reports. The ACNP announced in the week preceding the FDA advisory committee meeting that it had not found that SSRIs increased the risk of suicidal behavior in youth with depression.

A.The committees sought to confirm that the potential events in children represent suicidality and then ascertain whether they emerge from or are exacerbated by antidepressant treatment, or are symptomatic of depression unrelieved by the treatment. A similar assessment was conducted by the Psychopharmacological Drugs Advisory Committee in 1991 in response to concerns that fluoxetine prompted suicidality, and analyses were performed on data from studies with fluoxetine and other antidepressants in adults. Although it was concluded that there was no increased risk of completed suicide associated with either an SSRI antidepressant or placebo in adults with major depression, several possible drug-related mechanisms were considered. These included a paradoxical worsening of depression, onset of akathisia, induction of anxiety or panic, and switching of bipolar depression to mixed state. The current assessment of causality in children occurs against a high background of suicidality, according to Shaffer. "Suicidal ideation in high school students is extraordinarily common," he reported. "Almost 20% of American high school students will think about suicide during the past year." Shaffer elaborated, "Not only do many adolescents attempt and think about suicide, but they do it quite often, so that from the studies that we have, about half of suicide attempters will make only one attempt a year, and nearly a half will make two or more." In addition to the prevalence of suicidality among adolescents, there is also extensive use of antidepressants in this population, Giana Rigoni, Pharm.D., M.S., told the committees. "Approximately 10.8 million total prescriptions were dispensed for all SSRIs and atypical [antidepressants] in this population [17 years and younger], representing a substantial 7% of the market in 2002." Solomon Iyasu, M.D., M.P.H., described the adverse drug reactions with paroxetine spontaneously reported in the year following the pediatric supplemental studies. These included nine completed suicides, 17 suicide attempts and suicidal ideation in 11 patients. There had been no completed suicides within the pediatric controlled studies with paroxetine or the other antidepressants.

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