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Increasing scrutiny of antipsychotics

October 1, 2006
by MICHAEL LEVIN-EPSTEIN
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No atypical antipsychotics are approved for use in children, but their use by kids has increased six-fold

Physicians increasingly are treating children with behavior and mood disorders with second-generation antipsychotics. It's a situation that needs to be monitored closely, experts say, because none of these drugs are FDA approved for use in children and many children with behavioral health conditions aren't candidates for atypical antipsychotics, which can produce significant side effects.

Mark Olfson, MD, professor of clinical psychiatry at Columbia University Medical Center and New York State Psychiatric Institute, is very familiar with the phenomenon. He is the lead author of a study in the June issue of the Archives of General Psychiatry that found a substantial increase in the use of antipsychotics in the treatment of children with a variety of mental illnesses,1 and he is concerned about the trend.


Mark Olfson, MD The study found that in 1993, about 200,000 office visits in the United States by children to psychiatrists resulted in antipsychotics being prescribed, which jumped six-fold to more than 1.2 million a decade later. In fact, just four years ago 18% of all visits by patients age 20 or younger to psychiatrists resulted in prescriptions for antipsychotics. However, only 14% of children who received antipsychotics were diagnosed with a psychotic disorder.

Most of the antipsychotics prescribed were second-generation (atypical) antipsychotics; none has been approved by the FDA for use in children. Many of the prescriptions were written for children with ADHD and other attention disorders.

“Boys, particularly adolescent boys, are being prescribed [antipsychotics] at higher rates,” says Dr. Olfson. “A lot of the medications are being given for general aggression and behavioral symptoms rather than for specific psychotic disorders.”

While the study did not examine first-generation (typical) antipsychotics, 90% of the antipsychotic prescriptions from 2000 to 2002 were for second-generation drugs. In addition, many children were receiving at least one other psychotropic medication, such as stimulants, antidepressants, or mood stabilizers, at the time the antipsychotics were prescribed.

Antipsychotic treatment varied among subpopulations, with rates among children age 13 and younger about half that of those between 14 and 20. “White children had rates of antipsychotic treatment that were three times higher than those children of other racial/ethnic groups,” says Dr. Olfson.

In general, the survey results are disturbing, Dr. Olfson concludes. “We need to know a lot more about the effective dosages and safety of treating children with antipsychotic drugs,” he asserts.

Dr. Olfson and colleagues’ findings don't appear to be isolated. Jennifer Luddy, spokeswoman for pharmacy benefit manager Medco Health Solutions, says that according to an analysis of member claims from 2001 to 2005, the number of children age 19 and younger taking antipsychotics rose 73% during that period, compared with a 37% increase among members age 20 to 44. This finding differs from utilization data involving other behavioral medications, such as those for ADHD, in which use among children remained flat from 2004 to 2005, and antidepressants, which saw a significant drop in use among children in that one-year period. “Children are receiving the latest generation of antipsychotics… at a much higher rate than adults,” the analysis concludes.

That may be because the atypicals are viewed as less dangerous than older antipsychotics and can be helpful for conditions that previously were treated with other medications, according to Robert Epstein, MD, Medco's chief medical officer. “However, these drugs are not without their risks,” he notes. “There is evidence that the risk of diabetes and metabolic disorders from using atypical antipsychotics could be much more severe for pediatric patients than adults.”

Daniel Safer, MD, a psychiatrist and associate professor at Johns Hopkins University, agrees. He says that while the newer antipsychotics generally have fewer side effects, such as muscle spasms, compared with older medications, they're certainly not side-effect free. Although there have been informative studies on those side effects, lingering questions still remain on the long-term consequences of the use of antipsychotics in children.

At $5 to 12 per pill, newer antipsychotics are expensive, notes Dr. Safer. Those costs have prompted state Medicaid programs to consider formulary restrictions. About 30% of youth in the United States are enrolled in Medicaid, Dr. Safer notes, adding that these children receive second-generation neuroleptic drugs at a distinctly greater rate than those with commercial insurance.

But Robert Findling, MD, director of the Division of Child and Adolescent Psychiatry at University Hospitals of Cleveland, says not to forget about antipsychotics benefits for this population. “We certainly know that these medicines carry risks,” he says, “but they have benefits as well. What we need are accurate, reliable data to better characterize the risk-benefit ratio.”

While some antipsychotics (such as risperidone) have been studied more extensively than others, for the most part a sufficient number of large-scale, multisite clinical trials on children's use of antipsychotics have not been conducted, Dr. Findling says. However, he notes that “The best evidence suggests that for some of these youngsters, [antipsychotics] may be a very helpful intervention.” Physicians should stick with those interventions that are best supported by data and be diligent in monitoring for side effects, he concludes.

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