FDA Panel OKs 3 Antipsychotic Drugs for Pediatric Use, Cautions Against Overuse

KEYWORDS:
• ADOLESCENT PSYCHIATRY
• ANTIPSYCHOTIC AGENTS
• BIPOLAR DISORDER
• CHILD PSYCHIATRY
• DRUG REACTION, ADVERSE
• DRUG THERAPY
• OLANZAPINE
• PATIENT SAFETY
• QUETIAPINE
• SCHIZOPHRENIA
• UNITED STATES FOOD AND DRUG ADMINISTRATION
• ZIPRASIDONE

Despite safety concerns, a US Food and Drug Administration (FDA) advisory panel recommended in June that the agency approve 3 atypical antipsychotic drugs for the treatment of children and adolescents with bipolar disorder or schizophrenia. The drugs are associated with substantial weight gain and metabolic problems.

An expert panel advised the US Food and Drug Administration to approve quetiapine, ziprasidone, and olanzapine for use in some children with bipolar disorder or schizophrenia.

(Credit: Molecule Data Source: DrugBank Accession Nos. DB01124, DB00334, DB00246)

Two atypical antipsychotic drugs, risperidone and aripiprazole, are currently approved for the treatment of these conditions in pediatric patients. But the FDA asked its advisors to consider whether there is sufficient evidence to support approval of 3 similar drugs for use in younger patients. These drugs—quetiapine, ziprasidone, and olanzapine—are currently approved for treating schizophrenia or bipolar disorder in adults and are used widely off label in children.

In its briefing materials, the FDA noted that quetiapine, ziprasidone, and …