Quetiapine (Seroquel) Use in Pediatric Patients
Quetiapine is FDA-approved for use in pediatric patients 10 years and older for specific indications only, with significant caution required due to safety concerns. 1
FDA-Approved Pediatric Indications
Quetiapine is approved for:
- Adolescents aged 13-17 years with schizophrenia
- Children and adolescents aged 10-17 years with bipolar I disorder (manic episodes) 1, 2
Safety Considerations
Black Box Warning
The FDA label includes a black box warning that antidepressants, including quetiapine, increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Quetiapine is not approved for use in pediatric patients under ten years of age. 1
Adverse Effects in Pediatric Patients
- Cardiovascular effects: Blood pressure changes occur more frequently in children and adolescents than adults 1
- Metabolic effects: Weight gain and alterations in lipid profile require close monitoring 3
- Neurological effects: Although extrapyramidal symptoms are less common than with typical antipsychotics, monitoring is still required 3, 4
Dosing Guidelines
For FDA-approved indications:
Schizophrenia (13-17 years):
- Starting dose: 25 mg twice daily
- Target dose: 400-800 mg/day divided into two doses
- Maximum dose: Should not exceed adult maximum of 800 mg/day
Bipolar I Disorder - Manic Episodes (10-17 years):
- Starting dose: 25 mg twice daily
- Target dose: 400-600 mg/day divided into two doses
- Maximum dose: 600 mg/day
Monitoring Requirements
When prescribing quetiapine to pediatric patients:
- Baseline and regular monitoring of weight, BMI, blood pressure
- Metabolic parameters (glucose, lipids)
- Cardiac monitoring (consider ECG for QTc prolongation)
- Regular assessment for suicidal thoughts/behaviors, especially during initial treatment and dose changes 1
- Monitor for sedation, which may affect cognitive and motor performance 1
Off-Label Use
While quetiapine has been studied for other conditions in pediatric populations (including conduct disorder, autism spectrum disorder, and Tourette's syndrome), these are not FDA-approved indications 3. The risk-benefit ratio for off-label use must be carefully evaluated, particularly given the safety concerns.
Alternative Medications for Acute Agitation
For acute agitation in pediatric patients, consider alternatives with better safety profiles:
- Lorazepam 0.5-1mg orally (lower doses in younger children)
- Risperidone has more pediatric safety data than quetiapine for acute behavioral issues 5
Important Precautions
- Quetiapine crosses into breast milk and should be used with caution in nursing mothers 1
- Children with pre-existing cardiac conditions require additional monitoring
- Avoid in pediatric patients with dementia-related psychosis due to increased mortality risk 1
- Long-term safety data in pediatric populations is limited 3
Remember that quetiapine should be part of a comprehensive treatment program for adolescents with schizophrenia and pediatric bipolar disorder that includes psychological, educational, and social interventions 1.