From
Psychiatric News:
Days before a Food and Drug Administration (FDA) advisory committee reviewed the safety concerns about antipsychotic drug use in pediatric patients, two additional antipsychotics, quetiapine and olanzapine, were approved by the agency for treating youth with schizophrenia and those with bipolar I disorder.
With these additions, four second-generation antipsychotics (SGAs) have been approved by the FDA for use in patients under age 18: risperidone, aripiprazole, quetiapine, and olanzapine. Indications are for the acute treatment of schizophrenia and bipolar I manic or mixed episodes based on three- to six-week clinical trials in pediatric and adolescent patients. Risperidone and aripiprazole have also been approved by the FDA to treat irritability associated with autistic disorders.
Other SGAs, including ziprasidone and paliperidone, and recently approved
iloperidone and asenapine, are not approved for pediatric use but are sometimes prescribed off-label for children and adolescents.
In the past decade, mounting research evidence has linked SGAs to significant weight gain, increased blood glucose and cholesterol levels, and endocrine abnormalities in adult and underage patients.
At a public meeting held last December 8, representatives from the National Institute of Child Health and Human Development Antipsychotics Safety Therapeutic Working Group told the FDA's Pediatric Advisory Committee that the lack of knowledge about these drugs in the pediatric population is worrisome. A number of published epidemiological studies suggest that children may experience more dramatic weight gain and worse metabolic effects on SGAs compared with adults, the working group reported. Most recently, a study in the October 28, 2009, Journal of the American Medical Association showed that first-time SGA use was associated with a large increase in cardiometabolic risks in patients aged 4 to 19. The study found that average weight gain in youth taking SGAs ranged from 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) after a median of 10.8 weeks.
The working group urged the FDA and National Institutes of Health to fund and conduct postmarketing studies, both retrospective and prospective, to clarify the long-term effectiveness and safety of SGAs in children and adolescents.