Is olanzapine (atypical antipsychotic) approved for use in a 10-year-old child?

Olanzapine is Not FDA Approved for 10-Year-Old Children

Olanzapine is not approved for use in a 10-year-old child, as FDA approval only extends to adolescents aged 13 years and older for schizophrenia and bipolar I disorder. 1

FDA Approval Status and Age Restrictions

The FDA drug label for olanzapine clearly states that safety and effectiveness have only been established in:

• Adolescents aged 13-17 years for schizophrenia
• Adolescents aged 13-17 years for manic or mixed episodes associated with bipolar I disorder 1

The label explicitly states: "Safety and effectiveness of olanzapine in children <13 years of age have not been established." 1

Evidence from Clinical Guidelines

Multiple clinical practice guidelines support this age restriction:

• The American Academy of Child and Adolescent Psychiatry (AACAP) practice parameters for schizophrenia mention olanzapine studies only in children 6-14 years old as part of clinical trials, not as an approved indication 2

• In the AACAP practice parameter for bipolar disorder, olanzapine is listed as approved for acute mania in adults, with no mention of approval for children under 13 2

• For autism spectrum disorders, olanzapine has been studied in children 6-14 years old for symptoms like global functioning, aggression, and irritability, but is not listed as having specific FDA approval for this population 2

Safety Concerns in Children

The risk-benefit profile for olanzapine in children under 13 is particularly concerning:

• Significant metabolic side effects occur more frequently and severely in pediatric populations compared to adults, including:

  • Substantial weight gain (up to 16 pounds in short treatment periods)
  • Increased sedation
  • Greater increases in total cholesterol, triglycerides, and LDL cholesterol
  • Elevated prolactin levels
  • Increased hepatic aminotransferase levels 1, 3

• The FDA label specifically warns that "clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents." 1

• Even in the limited research on preadolescent children, adverse effects were significant enough that treatment was discontinued in all five children in one study within the first 6 weeks 4

Clinical Implications

If a psychiatric medication is needed for a 10-year-old child:

1. Consider FDA-approved alternatives for specific conditions:

   • For ADHD: stimulants, atomoxetine, or alpha-2 agonists
   • For irritability in autism: risperidone or aripiprazole (approved for children as young as 5-6 years)

2. If antipsychotic treatment is absolutely necessary for severe symptoms:

   • Risperidone has more pediatric data and FDA approval for younger children (for irritability in autism)
   • Aripiprazole also has approval for younger children in specific indications

3. Any off-label use would require:

   • Thorough informed consent discussing lack of FDA approval
   • Careful documentation of treatment rationale
   • Close monitoring for metabolic and other side effects
   • Consideration of referral to a specialist in pediatric psychopharmacology 2

The evidence clearly indicates that olanzapine should not be used in a 10-year-old child due to lack of FDA approval, limited efficacy data, and significant safety concerns in this age group.