More U.S. Kids Prescribed Off-Label Antipsychotics: Study

TUESDAY Sept. 18, 2012 -- Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States.

Off-label drug use is a term used to describe when drugs are prescribed using a dosage, type of dosage or for a purpose that hasn't yet been approved by the U.S. Food and Drug Administration.

In the study, researchers from the Children's Hospital of Philadelphia found a 62 percent jump in the number of publicly insured children between the ages of 3 and 18 taking antipsychotics. In 2007 alone, 65 percent of the 354,000 children on these drugs were taking them for uses that have not been approved by the FDA, the investigators pointed out.

"We knew that the number of children prescribed antipsychotics had grown steadily over the past two decades, particularly among children with public insurance," study author Meredith Matone, a researcher at PolicyLab, said in a hospital news release. "With this study, we wanted to learn more about why these drugs are being used so often, what diagnoses they're being used to treat, and how prescribing patterns changed over the course of the last decade."

The researchers pointed out that the spike in off-label antipsychotic use may be partly due to a 28 percent increase in the number of children diagnosed with a mental health disorder. Off-label use of these drugs is primarily associated with treatment for attention-deficit/hyperactivity disorder (ADHD) or conduct disorder. The researchers noted that in 2007, 50 percent of children taking antipsychotics were diagnosed with ADHD, and 14 percent of these had ADHD as their only diagnosis.

Children diagnosed with three or more mental health disorders were also among the largest group of kids taking antipsychotics. Children diagnosed with schizophrenia, bipolar disorder and autism were also most likely to be prescribed antipsychotics, according to the study published Sept. 10 in Health Services Research.

"The fact that we see an uptick in prescribing antipsychotics for many diagnoses tells us that antipsychotics are likely being used to treat specific behaviors, like aggression, that are shared among a variety of mental health diagnoses," Matone explained in the news release.

The increase in off-label use of antipsychotics, however, is a growing concern because these drugs have been linked to greater risk for serious side effects in children, including weight gain and diabetes, the researchers pointed out.

"If a child is prescribed an antipsychotic, it's important for doctors to inform parents and caregivers if the drug is being prescribed off-label, of potential side effects, and of counseling therapies that might be offered as an alternative to medication," study senior author, Dr. David Rubin, attending pediatrician, and co-director of the Children's Hospital of Philadelphia PolicyLab, said in the news release. "Given the significant proportion of off-label use of antipsychotics in children, it is reassuring that these drugs have been recognized as a priority for pediatric research by the [U.S.] National Institutes of Health."

The researchers concluded that more large-scale studies are needed to help formulate policies and guidelines for the use of antipsychotics among children.

More information

The U.S. Food and Drug Administration has more about off-label drug use.

Posted: September 2012


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