From the FDA Drug Label
The safety and effectiveness of brexpiprazole for treatment of major depressive disorder have not been established in pediatric patients. Pediatric use information is approved for Otsuka Pharmaceutical Company, Ltd.’s Rexulti® (brexpiprazole) tablets. However, due to Otsuka Pharmaceutical Company, Ltd.’s marketing exclusivity rights, this drug product is not labeled with that information.
Rexulti (brexpiprazole) is not FDA-approved for use in children 1.
From the Research
Rexulti (brexpiprazole) is FDA-approved for the treatment of schizophrenia in adolescents, but its use in children under 13 years is off-label. According to the most recent study 2, brexpiprazole is one of the drugs approved by the Food and Drug Administration for the treatment of schizophrenia in adolescents. However, except for haloperidol, all pharmacological indications for this disorder in children under 13 years are off-label.
Key Points to Consider
- The safety and efficacy of brexpiprazole have been established in adolescents, but not in children under 13 years through adequate clinical trials.
- Physicians sometimes prescribe medications off-label based on clinical judgment, but this should be done with extreme caution in children, especially with antipsychotics like Rexulti.
- The developing brains of children and adolescents may respond differently to psychiatric medications, and there are concerns about potential long-term effects on growth, development, and metabolic parameters.
- If a child is experiencing psychiatric symptoms that might typically be treated with antipsychotics in adults, it's essential to consult with a child psychiatrist who can recommend age-appropriate, FDA-approved treatment options specifically studied in pediatric populations.
Clinical Implications
- Brexpiprazole may be considered as a treatment option for adolescents with schizophrenia, but its use in children under 13 years should be approached with caution.
- Close monitoring of potential side effects, such as extrapyramidal symptoms, hyperprolactinemia, and weight gain, is necessary when using brexpiprazole in pediatric patients.
- Further studies are needed to establish the safety and efficacy of brexpiprazole in children under 13 years.