Study by Children’s Hospital of Philadelphia (CHOP) Found Increased Off Label

September 20, 2012

On September 10, 2012, Science Daily reported that the Children's Hospital of Philadelphia (“CHOP”) had published a national study in the journal Health Services Research that showed over the last decade an increase in prescriptions written for powerful antipsychotic drugs to treat publicly insured children.The researchers found a 62 percent increase in the number of Medicaid-enrolled children ages 3 to 18 were taking antipsychotics drugs by 2007.Despite the FDA having not approved the drug for treating ADHD, prescription antipsychotic drugs use was particularly high for children with ADHD.In 2007, 65% of children prescribed antipsychotics were using the drugs "off-label," or without FDA safety and efficacy data to support their usage.

David M. Rubin, MD, MSCE, a senior author of the study, attending pediatrician, and co-director of CHOP's PolicyLab stated that "[i]f 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."Mr. Rubin was pleased that many of these drugs have been recognized as a priority for pediatric research by the National Institutes of Health.The increased off-label use of antipsychotics drugs raising many concerns in light of evidence linking antipsychotics with an increased risk of serious metabolic side effects in children, weight gain and diabetes.

The researchers found that the 28% increase in the number of mental health diagnoses assigned to children does not entirely account for that the increased spike in antipsychotic prescriptions., The number of children prescribed antipsychotics has grown steadily particularly for children with public insurance.

For children using the antipsychotic drugs the most likely diagnoses are for schizophrenia, bipolar disorder and autism.However, these diagnoses did not make up the majority of antipsychotic drug users in the study.Children diagnosed with ADHD and those who were diagnosed with 3 or more concurrent mental health disorders made up the largest group of antipsychotics drug users.Moreover, 50% of children taking antipsychotics had a diagnosis of ADHD, while 14% had ADHD as their only diagnosis.