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Rising Use of “Off-Label” Antipsychotics in Children

August 8, 2012 — According to a study published in the Archives of General Psychiatry, antipsychotic drugs are prescribed in nearly one-third of all psychiatrist office visits with children and teenagers. Researchers say that many of the children are prescribed antipsychotics drugs “off-label” to treat attention deficit/hyperactivity disorder (ADHD), disruptive behaviors, and more. Unfortunately, children could be exposed to serious side effects — including weight gain and diabetes.

The U.S. Food and Drug Administration (FDA) has not approved any antipsychotic drugs for ADHD. In teenagers, the drugs are approved for schizophrenia, bipolar mania, tics associated with Tourette syndrome, and irritability with certain intellectual disabilities. However, between 2005 and 2009, 90% of antipsychotic prescriptions were written “off-label” to treat unapproved disorders. Approximately 40% of antipsychotic prescriptions were used to treat ADHD.

The researchers found that antipsychotic treatment has increased rapidly among young people. Antipsychotics are now prescribed in about the same proportion of youth and adult psychiatrist office visits (29% of adult visits compared to 30% of youth visits). They are among the most common and also costly type of medication.

Although the study does not determine whether the antipsychotic drugs were necessary, the researchers were concerned about the metabolic safety concerns of antipsychotic medications — especially because there is little empirical evidence that the drugs are effective for treating ADHD and other “off-label” disorders.

According to the researchers, “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.”

The study indicates an increasing clinical acceptance for prescribing antipsychotics to treat disruptive behavioral disorders — an important finding, given that disruptive behavioral disorder is the most common diagnosis in children and adolescent psychiatrist visits (63% and 34%, respectively). Disruptive behavior disorder is more commonly diagnosed in boys than in girls, and in nonwhite youths than in white youths.

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