FDA weighs in on SSRI use in children and teens

September 1, 2005

A recent report summarizes the findings of two committees of the Food and Drug Administration (FDA) that reviewed data on the safety and efficacy of selective serotonin reuptake inhibitors (SSRIs) for treating depression in children and adolescents. The Neuro-Psychopharmacologic Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, which enlisted the help of expert consultants, concluded that SSRIs and related antidepressants are causally related to an increased risk of suicidality in pediatric patients.

A recent report summarizes the findings of two committees of the Food and Drug Administration (FDA) that reviewed data on the safety and efficacy of selective serotonin reuptake inhibitors (SSRIs) for treating depression in children and adolescents. The Neuro-Psychopharmacologic Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, which enlisted the help of expert consultants, concluded that SSRIs and related antidepressants are causally related to an increased risk of suicidality in pediatric patients.

The two committees reanalyzed data from 24 trials that had been conducted by pharmaceutical companies. Specifically, experts from Columbia University reclassified all adverse events in those trials that were suggestive of suicidality: Those experts found 109 such events but no instances of completed suicide. The causal link demonstrated in the FDA analyses therefore focused entirely on suicidal ideation and behavior.

The committees also reviewed an additional randomized clinical trial of fluoxetine in pediatric patients and considered narrative testimony from families, health-care providers, and representatives of consumer advocacy groups. (Those narratives were not considered evidence of causality between SSRIs and suicidality.) In addition, the committees weighed the benefit-to-harm ratio of SSRIs when used in pediatric patients.

Commentary

Pediatricians wrote 17% of the 10.8 million prescriptions for antidepressants dispensed in 2002 for children between the ages of 1 and 17 years. Are SSRIs a part of your practice? If so, read this article and the accompanying editorials. The authors explain the evaluation process used by the FDA and describe how the American Academy of Pediatrics is planning to help you in this area of practice.