What selective serotonin reuptake inhibitors (SSRIs) are approved for use in pediatric patients?

FDA-Approved SSRIs for Pediatric Use

Only fluoxetine is FDA-approved for pediatric major depressive disorder, while sertraline is FDA-approved exclusively for pediatric obsessive-compulsive disorder (OCD). 1, 2

FDA-Approved Indications by Medication

Fluoxetine (Prozac)

• FDA-approved for pediatric major depressive disorder - this is the only SSRI with this indication 1
• Also approved for pediatric OCD 1
• Demonstrated consistent efficacy across three trials with significant reduction in depression symptoms (CDRS-R treatment effect -5.63,95% CI -7.38 to -3.88) 3

Sertraline (Zoloft)

• FDA-approved only for pediatric OCD - explicitly not approved for pediatric depression 2
• The FDA label specifically states: "Sertraline is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD)" 2
• Shows superior efficacy to fluvoxamine for OCD treatment in children and adolescents 4

Off-Label SSRI Use in Pediatrics

Commonly Used Off-Label (Not FDA-Approved for Pediatrics)

• Escitalopram - minimal CYP450 interactions, preferred in clinical practice despite lack of pediatric approval 1, 5
• Citalopram - least drug interactions but maximum dose limited to 40 mg/day due to QT prolongation risk 1, 5
• Fluvoxamine - greater potential for drug-drug interactions via multiple CYP450 pathways; less preferred 1, 5
• Paroxetine - should generally be avoided due to higher discontinuation syndrome risk and increased suicidal thinking compared to other SSRIs 5

Critical Safety Considerations

Black Box Warning

• All SSRIs carry FDA black box warning for suicidal thinking and behavior through age 24 years 1
• Pooled absolute rates: 1% for antidepressant-treated youth vs 0.2% for placebo (number needed to harm = 143) 1
• Meta-analysis shows increased risk of suicidal ideation and behavior (RR 1.80,95% CI 1.19 to 2.72) 3

Monitoring Requirements

• FDA mandates close monitoring for clinical worsening, suicidality, and unusual behavioral changes, especially during initial months and after dose adjustments 2
• Ideal assessment within 1 week of treatment initiation, then regularly throughout treatment 1
• Monitor for: ongoing depressive symptoms, suicide risk, adverse effects, treatment adherence, and environmental stressors 1

Clinical Dosing Parameters for Pediatric Use

Medication	Starting Dose	Effective Dose	Maximum Dose	FDA Pediatric Approval
Fluoxetine	10 mg daily	20 mg	60 mg	Depression & OCD
Sertraline	25 mg daily	50 mg	200 mg	OCD only
Escitalopram	10 mg daily	10 mg	20 mg	None
Citalopram	10 mg daily	20 mg	40 mg	None

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Efficacy Timeline

• Statistically significant improvement may occur by week 2, but clinically meaningful improvement typically not apparent until week 6, with maximal improvement by week 12 or later 1, 5
• This pharmacodynamic profile supports slow up-titration to avoid exceeding optimal dose 1