FDA’s class labeling states the pediatric suicidality warning and its basis: 24 short-term trials of nine antidepressants in more than 4,400 pediatric patients, with average risk of 4% versus 2% on placebo and no suicides. This class label implements the warning adopted after FDA’s 2004 review.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
PDF pp. 1–2 (Attachment 1)
FDA’s class labeling states the pediatric suicidality warning and its basis: 24 short-term trials of nine antidepressants in more than 4,400 pediatric patients, with average risk of 4% versus 2% on placebo and no suicides. This class label implements the warning adopted after FDA’s 2004 review. The label is direct evidence of the warning language and pooled trial basis.