Concerning harm/benefit ratio of escitalopram for pediatric generalized anxiety disorder

Background: Escitalopram was recently approved by the FDA for treating generalized anxiety disorder (GAD) in children and adolescents. Approval was mainly based on a phase 4 clinical trial and reference to other findings regarding escitalopram’s efficacy in treating GAD in adults and depression in children and adolescents. Both the FDA and the authors of the approval trial concluded that escitalopram is safe and effective in treating pediatric GAD. Method: This article aims to re-evaluate this conclusion by examining the results of the approval trial, the FDA-review, and findings from other studies. Results: The approval trial revealed a significantly increased rate of suicide ideation among patients on escitalopram compared to those on placebo. In contrast, the statistical significance of the main outcome (reduction in anxiety symptoms) was uncertain and likely not clinically meaningful. All six secondary outcomes (response/remission in anxiety symptoms) were statistically non-significant and close to zero. In the approval trial, patients on escitalopram had a higher risk of developing suicide ideation compared to achieving remission. Discussion: Considering the evidence from the approval trial and overall evidence from other studies on escitalopram, the harm to benefit ratio appears problematic in the treatment of pediatric GAD, or at the very least uncertain.