Medical Professionals Reference (MPR)Lexapro Approved for Generalized Anxiety Disorder in Children

The SSRI inhibitor was previously limited to adults.

As physicians, we are continually seeking effective treatment options for our pediatric patients. The recent FDA approval of Lexapro for pediatric GAD treatment marks a significant advancement in this field.

• The FDA has approved Lexapro (escitalopram) for treating GAD in pediatric patients aged 7 and above.
• Previously, Lexapro was only approved for adult patients.
• The approval was based on an 8-week, flexible-dose study comparing escitalopram to a placebo in pediatric outpatients.
• The primary endpoint was the change in Pediatric Anxiety Rating Scale (PARS) severity score from baseline to week 8.
• The study showed a statistically significant treatment difference with escitalopram compared to placebo on the PARS severity score for GAD.
• The adverse reaction profile in pediatric patients with GAD was similar to that observed in adult studies.
• Lexapro’s prescribing information contains a Boxed Warning about an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants.