News Update: Quetiapine tablets approved for schizophrenia in teens, bipolar disorder in children, teens

January 1, 2010

The FDA approved quetiapine tablets as monotherapy for the treatment of schizophrenia in adolescents (aged 13-17 years) and as either monotherapy or adjunctive therapy for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (aged 10-17 years).

In December 2009, the FDA approved quetiapine tablets (Seroquel, AstraZeneca) as monotherapy for the treatment of schizophrenia in adolescents (aged 13-17 years) and as either monotherapy or adjunctive therapy (with lithium or divalproex) for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (aged 10-17 years). This agent was previously approved for the treatment of bipolar disorder and schizophrenia in adults.

The safety and efficacy profile of quetiapine 400 to 800 mg in pediatric patients was assessed in 4 clinical trials, in which >1,000 pediatric patients were exposed to quetiapine. Across the studies, the most common adverse events associated with quetiapine were somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and weight increase.

The FDA mandated that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS) for quetiapine, including a medication guide and periodic assessments to determine patients' understanding of the potential risks associated with this agent.