Widespread Use Of Antipsychotics In Children Under Fire From FDA

Kathleen Blanchard's picture
Antipsychotics in Children

Previous studies have shown that antipsychotics, used in treatment of early schizophrenia in children, are helpful for childhood treatment of mental illness. The increasing popularity of prescribing antipsychotics for children who are aggressive, have frequent outbursts, or other behavioral problems, is now under fire from the FDA.

Newer antipsychotics carry health risks for children, including significant weight gain and metabolic disorders. Off-label prescribing of Risperdal may have been responsible for the death of a nine-year-old boy from stroke.

Following an eight week study on antipsychotic drug treatment in children, Linmarie Sikich, MD from the University of North Carolina, Chapel Hill told Medscape Psychiatry in September, "Our conclusion is that older, mid-potency antipsychotics like molindone really should be considered as first-line treatment for early-onset schizophrenia and that they may offer significant health advantages in terms of avoiding weight gain and the subsequent risk for diabetes and cardiovascular disease".


The antipsychotic drug research (Abstract), published in the September issue of American Journal of Psychiatry, was the result of the National Institute of Mental Health funded Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). Currently, 98% of antipsychotics used in childhood cases of mental illness are from newer drugs, though no proof exists that they are superior.

Newer antipsychotics can put children at risk for heart disease and physical disabilities. The FDA asked a panel of drug experts to support the findings, but their proposal was not approved.

Risperdal, a second generation, or newer antipsychotic was used to treat schizophrenia and bi-polar disorder was prescribed to 389,000 children and teenagers last year. Over half were younger than age twelve. Off-label prescriptions included treatment for attention deficit disorder (ADD); a condition not approved for treatment is Risperdal. As a result, thirty-one children died, and 1207 experienced serious side effects. Other antipsychotic drugs under scrutiny include Seroquel, Geodon and Abilify.

Thomas Laughren, director of FDA's division of psychiatry products believes physician education is needed to stop the practice of prescribing antipsychotics to children that could cause permanent damage – a job that should be tackled by medical specialty societies. Laughren also suggest changes in labeling, stating "he's anxious" to see what more can be done to curb the widespread use of antipsychotics that are no more effective than well known front-line medications.
Newer Antipsychotics Appear No Better Than Older Agent in Treating Child, Adolescent Schizophrenia.