From Our 2006 Archives

More Kids Get Antipsychotic Drugs

Some Experts Worry About Safety of 'Atypical' Antipsychotic Drugs

WebMD Medical News

Reviewed ByLouiseChang,MD
on Wednesday, May 03, 2006

May 3, 2006 -- Children represent the fastest growing group of users of a new generation of antipsychotic medications, even though the drugs are not approved for their use and serious safety concerns remain.

Between 2001 and 2005, prescriptions for atypical antipsychotic drugs increased by 80% among children and teens, compared with an increase of 46% among adults aged 20 to 44.

In 2005, roughly 97% of all antipsychotic prescriptions written for U.S. children were atypical antipsychotics, according to an analysis conducted by pharmacy benefit manager Medco Health Solutions Inc.

While it is clear that more children are taking antipsychotic drugs, it is less clear why.

ADHD and Antipsychotic Drugs

Studies conducted at Vanderbilt Medical Center in Nashville, Tenn., suggest that the drugs are routinely prescribed for attention deficit hyperactivity disorder (ADHD).

But a Medco official says he does not believe this is the case. Lon Castle, MD, says the increase in use is being driven by a growing recognition that children suffer from psychotic illnesses and other psychiatric conditions.

"When I was in training -- and even in practice -- the thinking was that children didn't have psychiatric conditions like schizophrenia or bipolar disorder," Castle tells WebMD. "But within the last few years, psychiatry has made dramatic strides and we are now better able to identify children who probably do have these diseases."

Increase Among Girls

Atypical antipsychotics are approved for use in adults to treat psychotic illnesses like schizophrenia and also Tourette's syndrome. But they are also widely used "off label" to treat many psychiatric conditions. "Off label" refers to prescribing drugs to treat conditions for which they are not approved by the FDA.

Atypical antipsychotics include the drugs Clozaril, Risperdal, Zyprexa, Seroquel, and Geodon.

The older antipsychotics carry a high risk of movement-related side effects.

Although the newer generation of drugs is believed to be better tolerated, few studies have been done in children. Atypical antipsychotics are known to promote weight gain, and the FDA has warned that their use is associated with an increased risk of diabetes and other obesity-related conditions.

The Medco analysis, which included 2.5 million of its 55 million members, found that prescriptions for the drugs among children and teens rose steadily between 2001 and 2005, while prescriptions for drugs approved for the treatment of ADHD remained flat.

The growth was most pronounced in girls. There was a 110% increase in prescriptions written for atypical antipsychotics among girls under the age of 20 during the years studied, compared with a 27% increase among women 20 years and older.

In 2005, about six children out of 1,000 were taking atypical antipsychotic drugs, compared with 10 adults out of 1,000, the Medco analysis found.

Prescriptions for Children

Vanderbilt University Medical Center pediatrician William Cooper, MD, and colleagues were among the first to investigate the increase in antipsychotic drug use among children and teens.

In a study published in the summer of 2004, the researchers reported that prescriptions for atypical antipsychotics doubled among Tennessee children on Medicaid between 1996 and 2001.

They further reported that 43% of prescriptions were written for children with ADHD or a related disorder as the primary diagnosis, while just 14% were written for bipolar disorder and 9% for schizophrenia or other psychotic conditions.

In a later nationwide study, the researchers concluded that 6 million prescriptions for atypical antipsychotics were written for children between 1995 and 2002. Again the researchers found that a large percentage of the prescriptions were written for children with ADHD as the primary diagnosis.

"The bottom line is that we are seeing a huge increase in the use of these medications among children, and we are not sure if they work or if they are safe," Cooper tells WebMD. "These drugs have not been tested for many of the indications that they are being used for."

Safety Issues

New safety concerns were raised this week in a series of articles published in USA Today. An investigation by the newspaper revealed that there were at least 45 unexplained child deaths between 2000 and 2004 in which an atypical antipsychotic drug was listed by the FDA as the "primary suspect."

Castle says there are "very real concerns" about the safety of the drugs, and his sentiments were echoed by Medco's Chief Medical Officer Robert Epstein, MD, in a news release.

"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, and there is a need for more studies to understand the long-term effects of these drugs on children," he says.

A drug industry group --- the Pharmaceutical Research and Manufacturers of America (PhRMA) -- says atypical antipsychotics are a useful tool in treating mental illness. Sharon Briger, PhRMA's senior director of clinical medical policy, issued this statement in a news release:

"Atypicals, a new class of antipsychotics that treat schizophrenia, bipolar and other mood disorders, represent an important advancement in treating patients of all ages with serious mental illnesses. Without medication, these disorders could lead to complications and even death. Whether or not a medicine is appropriate or not for a patient is a decision that should be left up to health care providers who are trained to recognize particular patterns and diagnose accordingly."

SOURCES: "New Data: Antipsychotic Drug Use Growing Fastest Among Children," report from Medco Health Solutions, Inc. Lon Castle, MD, director of medical policy and programs, Medco Health Solutions Inc., Franklin Lakes, N.J. William Cooper, MD, associate professor of pediatrics, Monroe Carell Jr. Children's Hospital, Vanderbilt University Medical Center, Nashville, Tenn. "New Antipsychotic Drugs Carry Risks for Children," USA Today, May 2, 2006. Robert Epstein, MD, chief medical officer, Medco Health Solutions, Inc. News release, Pharmaceutical Research and Manufacturers of America.

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