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August 8, 2007

Benefits and Harms of Pediatric Antidepressant Medications—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2007;298(6):626-627. doi:10.1001/jama.298.6.627

In Reply: Dr Waslick is concerned that our analysis might inflate the risk-benefit ratio for antidepressants by concentrating only on the risk of treatment-emergent suicidal ideation and attempts. Our intent was not to mislead, but rather to explicitly compare the benefit of antidepressants to the risk of treatment-emergent suicidal ideation/suicide attempt, because this is the adverse effect that is the most frightening, has engendered the most negative publicity, has resulted in a black box warning from the US Food and Drug Administration, and has been associated with a decrease in use of antidepressants in children and adolescents.1,2 We explicitly acknowledged this limitation in the Comment section. Although we could have been clearer in defining what was meant by a risk-benefit ratio, we assume that most readers regard treatment-emergent suicidal ideation and behavior to be in a different category of concern than discontinuation of treatment because of adverse somatic symptoms. We do agree that a complete analysis of other adverse effects associated with short- and long-term antidepressant treatment is warranted. Since individual trials were all underpowered to compare rates of less common adverse events, the pooling of individual patient data from available randomized controlled trials (“mega-analysis”) may be an effective strategy for identifying clinically important, but rare, safety outcomes.3

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