Antipsychotic use in children aged 3-18 years increased by 62% between 2002 and 2007, according to Medicaid data from about 15 million children in the United States.
Although the use of second-generation antipsychotics (SGAs) in children has grown in recent decades, evidence supporting their effectiveness for many conditions is limited, said Meredith Matone of the Children’s Hospital of Philadelphia and her colleagues, including Dr. David M. Rubin, codirector of policy lab at the hospital and an associate professor of pediatrics at the University of Pennsylvania, Philadelphia.
"In light of recent research indicating rising use of antipsychotics in children coupled with concurrent research demonstrating significant side effects of these medications, it felt like a critical next step to understand who the populations of users were and how this population may have changed over the course of the last decade," she said in an interview. The findings were published online (Health Services Research Sept. 5 [doi:10.1111/j.1475-6773.2012.01461.x]).
To examine the relationship between diagnosis and prescription of SGAs, the researchers reviewed Medicaid data from children in 50 states and the District of Columbia between 2002 and 2007.
Overall, 354,000 children were using SGAs in 2007. Of these, 39% were diagnosed with attention-deficit/hyperactivity disorder (ADHD), 11% with bipolar disorder, 12% with ADHD and bipolar, and 38% with other conditions.
In 2007, 50% of children taking antipsychotics had a diagnosis of ADHD, and in 14%, ADHD was their only mental health diagnosis. Approximately two-thirds (65%) of the antipsychotic prescriptions for children were for off-label use of the drugs. "The lack of safety and efficacy data is especially significant given a growing body of research indicating serious adverse side effects of antipsychotics in children," the researchers noted.
The study points out that neither the American Academy of Child and Adolescent Psychiatry nor the American Academy of Pediatrics recommends second-generation antipsychotics for ADHD management.
Ms. Matone and her colleagues said they had expected to see use of the medications for diagnoses associated with diagnoses such as ADHD and conduct disorder – despite the lack of Food and Drug Administration approval of the drugs for those indications. "However, the size of this population of off-label users and its growth over time was surprising," Ms. Matone said.
"For clinicians, these findings reinforce the importance of both understanding safety concerns associated with pediatric antipsychotic use and being informed about the efficacy and availability of alternative non-pharmacologic treatment therapies.
"There is also a need for information sharing with parents about treatment decisions involving off-label medication use, safety concerns, and alternative treatment approaches," she said.
In addition, further research is needed to explore the indication for antipsychotic use in patients with behavioral problems such as ADHD, the researchers noted.
The study was supported by the Agency for Healthcare Research and Quality and by a fellowship from the Stoneleigh Foundation to Dr. Rubin.