August 6, 2004

Children’s Hospital researchers find increase in antipsychotic prescriptions

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Jennie Conrad, mother of three children with ADHD, is concerned with the overuse of antipsychotic drugs to treat the condition. Photo by Neil Brake

Children’s Hospital researchers find increase in antipsychotic prescriptions

At a time when parents, schools and physicians still struggle with the perceived overuse of the medication Ritalin to treat children with attention difficulties, a new study suggests the potential for another controversy.

Researchers at the Monroe Carell Jr. Children’s Hospital at Vanderbilt have found a new class of antipsychotic medications is being prescribed for an increasing number of TennCare children with attention deficit/hyperactivity disorder (ADHD).

The study, published in the August Archives of Pediatrics & Adolescent Medicine, found that nearly one in 100 adolescent TennCare recipients are being prescribed powerful antipsychotic medications for behavioral problems associated with ADHD.

The study, authored by William Cooper, M.D., associate professor of Pediatrics at the Children’s Hospital, tracked medical records of thousands of children listed in Tennessee’s managed care program for Medicaid enrollees and the uninsured (TennCare) between 1996 and 2001.

The study revealed that between 1996 and 2001 the proportion of TennCare children who were new users of antipsychotic medications increased from 23 per 10,000 children to 45 per 10,000.

Use ADHD and mood disorders increased more than twofold. Perhaps most concerning, the adolescent population had more than a threefold increase in use of the drugs for ADHD/conduct disorder, that amounted to nearly one in every 100 adolescents covered under TennCare.

Jennie Conrad knows about the use of medications to treat children with ADHD and behavior disorders. She worked for the Regional Interventional Program (RIP) helping families who have children with behavior that interferes with schoolwork.

Conrad said RIP promotes the use of behavior modification including positive reinforcement — techniques she has tried with two sons and a daughter with ADHD or related conditions.

“I struggled with the decision to use medications. I feel like it’s diagnosed a little soon, and medications are given a little too quickly, sometimes,” Conrad said. “But after we tried behavior modification, I realized sometimes you do need to go to medication. Children need to be calm enough that they can learn and not disrupt others.”

Two of Conrad’s sons are currently taking Stratera, a popular new drug for ADHD with fewer side effects than Ritalin. One boy still has trouble controlling his aggression. Cooper says it appears antipsychotic medications are targeted to help aggressive behavior associated with ADHD.

“In this society, with aggression, they want to nip that in the bud,” said Conrad. “But as a parent, I would want to know a lot about the drugs. What are the short-term and long-term side effects? I would really want it to be studied.”

Cooper and Catherine Fuchs, M.D., associate professor of Psychiatry in the division of Child and Adolescent Psychiatry, said this was precisely the concern when, starting in 1998, they began noticing an increasing number of children in Vanderbilt’s clinics who were on antipsychotic drugs. In 2001, Cooper and Fuchs began the retrospective research.

“There were three areas of concern. First, these drugs appeared to be prescribed for disorders they are not proven to treat in children; second, the side effects of these drugs in children are not well understood; and third, usage of these drugs appears to be increasing dramatically.” Cooper said.

The drugs were introduced during the 1990s as a new generation of antipsychotics, and include clozapine, risperidone, olanzapine, quetiapine fumarate and ziprasidone hydrochloride.

They were approved for use in psychosis and Tourette’s syndrome. Cooper theorized the introduction of this new class of antipsychotic drugs was part of the reason for the increase in off-label use. The older antipsychotic drugs are well known to have potential side effects like movement disorders and other serious neurologic problems not seen in the newer class of drugs.

“The newer drugs do have their own set of potential side effects, including serious weight gain, heart rhythm problems, and diabetes,” said Cooper. “These are potential side effects that are not well understood when applied to children. In fact, some preliminary studies suggest that the side effects from these medications are more common and may be more severe in children than in adults.”

Cooper’s area of special interest is application of research to public health programs.

He and Fuchs, along with co-investigators Gerald Hickson, M.D., professor of Pediatrics and Psychiatry; Patrick Arbogast, Ph.D., assistant professor of Preventive Medicine and Wayne Ray, Ph.D., director of the division of Pharmacologic Epidemiology, were assisted by the state’s TennCare program in gathering data for the study. The study’s authors eliminated any child listed with a severe disability, including a severe mental illness like psychosis or autism.

Cooper said there is modest evidence to support the use of this newer class of antipsychotic medications to treat severe disruptive behaviors associated with autism and mental retardation, but not for behavioral symptoms associated with ADHD and conduct disorders.

He said it may be perceived that newer antipsychotic drugs are safer for children, and that the drugs can help children with aggressive behaviors.

“But those studies still need to be done. We don’t know if the drugs are really safe and beneficial when used this way,” Cooper said.

Conrad said she hopes this study makes parents think seriously before seeking these powerful drugs as a quick fix.

“Maybe it’s because I’m older and we didn’t always think we had to go to a pill to fix things, but today people think a pill is an instant fix. I don’t think it is. It takes a combination of things,” Conrad said.

Cooper says anecdotal reports are leading him to believe the same questions need to be asked for all children. While this study focused on the TennCare population, Cooper and his colleagues are already working with CDC records in a new study to find out if this concern extends to the entire population.

“We would like for physicians to think very carefully before prescribing these drugs to children,” Cooper said. “And we hope this study encourages more research to find out how these drugs might be best used to help children.”

Fuchs agrees.

“The goal of this article is to encourage physicians to carefully consider the risk/benefit ratio in their decision making about prescribing practices for the new generation of antipsychotics.

The medications are very effective. However, it is important for us as physicians to develop increased understanding of behavioral changes as they relate to illness; with the understanding that we will be able to make more effective treatment decisions.”