Prescribing Age for Quetiapine (Seroquel)
Quetiapine is FDA-approved for adolescents aged 13-17 years for schizophrenia and for children and adolescents aged 10-17 years for bipolar mania, but is not approved for pediatric patients under 10 years of age. 1
FDA-Approved Indications by Age
Schizophrenia
- Adults: Approved
- Adolescents (13-17 years): Approved
- Children under 13 years: Not approved
Bipolar Disorder
- Adults: Approved
- Children and adolescents (10-17 years): Approved for bipolar mania only
- Children under 10 years: Not approved
Bipolar Depression
- Adults: Approved
- Children and adolescents: Not approved for patients under 18 years
Evidence Supporting Pediatric Use
The FDA approval for quetiapine in adolescents with schizophrenia is based on a 6-week, double-blind, placebo-controlled trial that demonstrated significant improvement in symptoms at doses of 400 and 800 mg/day 2. This study showed that quetiapine was generally well-tolerated in adolescents with a safety profile similar to that reported in adults.
For bipolar mania, approval for ages 10-17 years was based on a 3-week, double-blind, placebo-controlled trial that demonstrated efficacy and safety in this population 1.
Safety Considerations in Pediatric Populations
When prescribing quetiapine to pediatric patients, several important safety considerations should be noted:
Metabolic Effects: Children and adolescents may experience significant weight gain, hyperlipidemia, and increased risk of diabetes. In clinical trials, potentially clinically significant elevations were observed in triglycerides (9.3% with quetiapine XR vs 1.4% with placebo) 3.
Blood Pressure: Increases in systolic and diastolic blood pressure occurred more frequently in children and adolescents compared to adults 1.
Orthostatic Hypotension: Interestingly, orthostatic hypotension occurred less frequently in children and adolescents (<1%) compared to adults (4-7%) 1.
Dosing Considerations: The pharmacokinetics of quetiapine differ between children/adolescents and adults. When adjusted for weight, the AUC and Cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults 1.
Off-Label Use
Despite lack of FDA approval, quetiapine has been studied in various pediatric psychiatric conditions:
- An open-label study suggested quetiapine may be safe and effective in treating 10 youth with schizoaffective or bipolar disorder 4.
- A long-term (88-week) open-label extension trial in adolescents aged 12.3 to 15.9 years with schizoaffective disorder or bipolar disorder with psychotic features suggested quetiapine was well-tolerated and efficacious 5.
- However, a more recent 8-week study of quetiapine XR in pediatric bipolar depression (ages 10-17) failed to demonstrate efficacy relative to placebo 3.
Important Warnings
The FDA label for quetiapine includes a boxed warning stating that it is not approved for the treatment of patients with dementia-related psychosis due to increased mortality risk in elderly patients. Additionally, there is a warning about increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults 1.
Conclusion
When prescribing quetiapine, clinicians should adhere to the FDA-approved age ranges: 13 years and older for schizophrenia, and 10 years and older for bipolar mania. Use in younger children or for other indications represents off-label prescribing and should be approached with caution, weighing potential benefits against risks, particularly metabolic effects and cardiovascular changes that may be more pronounced in pediatric populations.