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Shedding Light on the 'Black Box': Treating Pediatric Depression

(PSYCHIATRIC TIMES) - The U.S. Food and Drug Administration, after careful deliberation, concluded that antidepressants convey a 1.8-fold increased risk for suicidal ideation or suicide attempt in patients treated with antidepressants. In response, the FDA mandated that all manufacturers of antidepressants place a "black box" warning about this risk to accompany each prescription of an antidepressant. The increased concern about suicidality and antidepressants in the pediatric age group leads to several questions that must be addressed by clinicians, families and patients.

The Basis for ‘Black Box'

The FDA commissioned Columbia University to convene an international consensus panel of independent experts in adolescent suicidal behavior in order to review and standardize the classification of adverse events in all available placebo-controlled clinical trials for pediatric depression, anxiety and obsessive-compulsive disorder. The FDA then conducted analyses using these classifications to test if there was an association between medication use and suicidality. Their meta-analysis found a 1.8-fold increased risk for new-onset or worsening suicidal ideation or attempt in patients treated with medication versus those treated with placebo (FDA, 2004).

This association between antidepressant use and emergent suicidality was almost never statistically significant within an individual trial. However, this relationship was statistically significant in the FDA's meta-analysis, and the direction of this effect was consistent in enough different individual studies that the FDA's Advisory Panel concluded that this effect, while small, was real. Almost all of the suicidality-related adverse events reported were either new-onset or worsening ideation, with relatively few attempts and no suicide completions among over 4,400 participants. Moreover, it is important to note that, despite a rapid increase in antidepressant prescriptions for adolescents, the adolescent suicide rate has been declining for the past decade.

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