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This article will review evidence that led the Food and Drug Administration to issue a black-box warning about the risk of suicidality (suicidal thoughts and behavior) in children and adolescents during treatment with antidepressants. Reanalysis of data from randomized clinical trials of antidepressants in the pediatric population revealed a significantly greater risk of suicidality for drug groups (4%) compared to placebo groups (2%) in a sample of approximately 4,000 subjects. There were no completed suicides. The small but statistically significant risk of suicidality was not restricted to subjects being treated for depression. With respect to efficacy, only three (20%) of 15 antidepressant trials submitted to the FDA for pediatric depression demonstrated superiority of drug over placebo. The essential message of the black-box warning is to remind prescribers and consumers about the importance of monitoring patients closely for adverse behavioral changes during the initiation of (or changes in) antidepressant therapy. Implications of the FDA actions for clinical practice will also be addressed.
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Deciding whether to recommend a drug treatment or not depends on assessment of both risk and benefit. In the case of adults with depression, the calculation of the risk-to-benefit ratio is more straightforward because the benefit of antidepressants is so well-established both in acute and long-term trials.47 With the advent of alternatives to the tricyclic antidepressants (eg, SSRIs), tolerability and safety (including risk of death from overdose) have greatly improved.48,49 Cost effectiveness is another consideration but one that is beyond the scope of this review.50 The dilemma facing medication treatment in pediatric depression is that apart from fluoxetine (which has an FDA indication in children down to 7 years of age) the available evidence supporting antidepressant efficacy is negative or weak.51 On the other hand, the preponderance of clinical experience suggests antidepressants are often effective in the long-term management of pediatric depression.52 The paucity of empirically derived long-term outcome data on antidepressants in children and adolescents marks a major gap in our knowledge.53
Becoming a man; the first child; the second child; all of these are topics that "The Great Santini" by Pat Conroy and "Death of a Salesman" by Arthur Miller have in common.