Is it safe to use olanzapine (an atypical antipsychotic) with Prozac (fluoxetine, a selective serotonin reuptake inhibitor (SSRI)) in a 10-year-old child?

Safety of Olanzapine with Fluoxetine (Prozac) in a 10-Year-Old Child

The combination of olanzapine and fluoxetine is not recommended as first-line treatment for a 10-year-old child due to significant safety concerns, particularly regarding metabolic side effects and limited FDA approval for this age group.

FDA Approval Status and Guidelines

The combination of olanzapine and fluoxetine has specific limitations in pediatric populations:

• Olanzapine is FDA approved for adolescents 13 years and older with schizophrenia or bipolar disorder, but not for children under 13 years 1
• The olanzapine/fluoxetine combination is only FDA approved for bipolar depression in children 10-17 years 2, 3
• Fluoxetine (Prozac) is the only antidepressant FDA approved for major depression in children 8 years and older 2

Safety Concerns

Major Safety Issues

1. Metabolic Effects:

   • Weight gain is extremely common and more pronounced in children than adults 2, 4, 5
   • Studies show weight gain of up to 16 pounds in preadolescent children 6
   • Hyperlipidemia is very common among children treated with olanzapine 3
   • Blood glucose abnormalities occur in approximately 4% of young children 4

2. Sedation:

   • Occurs in approximately 48% of young children 4
   • May persist even after weeks of treatment 7

3. Other Common Adverse Effects:

   • Hepatic enzyme elevations (7% of young children) 4
   • Extrapyramidal symptoms (9% of young children) 4
   • ECG abnormalities (14% of young children) 4
   • Increased prolactin levels 7

Special Considerations for Combination Therapy

The 2007 AACAP Practice Parameter for Bipolar Disorder specifically notes that the combination of olanzapine and fluoxetine is approved for bipolar depression in adults, but cautions about using these medications in very young children 2:

• "The short- and long-term safety of mood stabilizers and atypical antipsychotic agents for this indication in young children has not been established."
• "It is particularly important with preschoolers that intervention strategies address environmental, developmental, temperamental, and social factors that may relate to symptom presentation."

Clinical Decision Algorithm

1. First determine if this combination is absolutely necessary:

   • Has the child failed trials of safer medications?
   • Is the diagnosis bipolar depression (the only FDA-approved indication for this combination in this age range)?
   • Have non-pharmacological interventions been maximized?

2. If proceeding with treatment:

   • Start with the lowest possible doses
   • Monitor closely for:
     • Weight gain (weekly measurements)
     • Metabolic parameters (baseline and regular lipid panels, glucose)
     • Liver function tests
     • Sedation and cognitive effects
     • Extrapyramidal symptoms

3. Consider alternatives:

   • For bipolar disorder: Consider lithium (approved down to age 12) or other mood stabilizers 2
   • For depression: Consider fluoxetine monotherapy (FDA approved for children 8+) 2
   • For psychosis: Consider other atypical antipsychotics with potentially better metabolic profiles

Important Monitoring Parameters

If using this combination despite concerns:

• Baseline assessments: Weight, height, BMI, waist circumference, blood pressure, fasting glucose, lipid panel, liver function tests, ECG
• Regular monitoring: Weekly weight checks initially, monthly metabolic monitoring
• Behavioral monitoring: Watch for sedation, cognitive effects, and paradoxical reactions
• Long-term monitoring: Growth trajectory, development milestones

Conclusion

The combination of olanzapine and fluoxetine carries significant risks in a 10-year-old child, particularly regarding metabolic effects. While this combination is FDA approved for bipolar depression in children 10-17 years, the risk-benefit ratio must be carefully considered, and safer alternatives should be tried first whenever possible.