Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process

In this commentary we review the recent approval of escitalopram for generalized anxiety disorder (GAD) in children and adolescents. We critically discuss the FDA approval document and the approval trial. In the approval trial, efficacy was not clinically meaningful, statistical significance uncertain, and there were significantly more adverse events with escitalopram than with placebo. Relative to placebo, children and adolescents exposed to escitalopram were more likely to become suicidal than to experience a clinically relevant improvement in anxiety. Overall, the harm-benefit ratio seems problematic for escitalopram for pediatric GAD.