Rising Use of “Off-Label” Antipsychotics in Children

August 8, 2012 — The Archives of General Psychiatry has published a study that has found a rapid increase in the prescription of antipsychotic drugs to children and teenagers. The drugs are often prescribed “off-label” to treat disruptive behavior disorders and Attention Deficit/Hyperactivity Disorder (ADHD). The researchers raised concerns about the growing clinical acceptance of antipsychotics in children, the lack of studies regarding their safety and effectiveness, and severe side effects that include metabolic changes, weight gain, and diabetes.

Between 2005 and 2009, prescriptions for antipsychotic drugs were written in approximately one-third of psychiatrist visits involving children and teenagers. The rate of prescriptions is now comparable to the rate of adults who are given antipsychotics.

Although the rate of prescriptions is the same, the reason for giving the drugs is different. Children were primarily given antipsychotics after a diagnosis of ADHD or disruptive behavior disorder, whereas adults were primarily prescribed the drugs to treat depression and bipolar disorder.

The problem is, antipsychotic drugs are not FDA approved to treat ADHD or disruptive behaviors in children. In fact, between 2005 and 2009, 90% of prescriptions for antipsychotics in children were “off-label” — for purposes not approved by the FDA. About 40% of antipsychotic prescriptions were for ADHD. The FDA has only approved these drugs to treat schizophrenia, bipolar mania, tics from Tourette syndrome, and irritability in autistic children.

The study did not investigate whether the drugs were necessary or beneficial for treating the “off-label” conditions. The researchers said the data indicates a growing clinical acceptance of prescribing antipsychotics to children for unapproved purposes.

The data also raises concerns about the possible side effects. “Young people may be especially sensitive to the adverse metabolic effects of second-generation antipsychotics. As compared with adults, children may be more vulnerable to antipsychotic-induced weight gain and perhaps even to antipsychotic associated diabetes.”

Disruptive behavior is one of the most common diagnoses in children and adolescent psychiatric visits (63% and 34% of visits, respectively). The disorder is more commonly diagnosed in boys than girls, and in nonwhites than whites.

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