Suicide risk in pediatric populations treated with antidepressives: impact of the 2003 alert in prescription and research in efficacy and safety

Abstract

Objective: To analyze the use and research in efficacy and safety of antidepressants in Mayor Depressive Disorder (MDD) in paediatric population after the 2003 international warning from regulatory agencies (EMA, FDA) about an increased suicide risk in children and adolescents treated with antidepressants. 

Method: A review of the last 10 years publications regarding the prescription trends and efficacy and safety of antidepressants in paediatric depression was carried out. Cochrane and Pub Med databases were used. 

Results: Since the alert there has been a change in previous ascending trends of antidepressant prescription to children and adolescents with a decrease in their use, as well as an increase in the completed suicide rate in this population. Clinical management and monitoring of these patients have been slightly modified. Since 2004, two studies (escitalopram, citalopram) showed significant efficacy vs placebo for paediatric depression, adding more evidence to previous Fluoxetine results. Three studies show significant efficacy in adolescent MDD but only one with sertraline was designed to detect subgroup age differences. No more evidence of increased suicide risk has been found. 

Conclusions: Safety warnings from regulatory agencies EMA and FDA about antidepressant use in paediatric population has modified sligthtly clinical practice, with a decreased trend in prescription. More research has been conducted since 2004, adding evidence for efficacy but not for an increased risk of suicide. Methodological flaws of conducted studies after the warnings remain similar to previous research.