A 2008 study in Child and Adolescent Psychiatry and Mental Health reports that more than 8 million American children and adolescents take one or more psychotropic drugs to treat such mental health issues as bipolar disorder, attention-deficit hyperactivity disorder and behavior problems without a clear diagnosis. It's a rate higher than any other country in the world, the study shows, and there are no long-term data on the effects of these medications on child development, says Carl Tishler, PhD, an adjunct associate psychology professor at The Ohio State University. In addition, most of these medications have not been approved for use with children.

"Fifteen or 20 years from now, we may have a generation of people who as children took these medications for an extended period of time, and now have extended problems as a result," says Tishler, lead author of an article published in the April issue of the Journal of Medical Ethics. Many of the drugs, he says, may have short- and long-term negative effects on physical growth, brain development, behavior, mood and cognitive functioning. "We just don't know."

Tishler's paper, co-authored with Natalie Reiss, PhD, a psychologist at Case Western Reserve University, encourages researchers and ethicists to consider changes such as the use of more subtherapeutic dosing and randomized, double-blind studies with children, to allow for more pediatric Phase I clinical trials with psychotropic drugs. Tishler also recommends improving reimbursement for children's participation in clinical trials by providing study participants with free health-care services for a year rather than small trinkets such as teddy bears or payments to parents, which can be viewed by some as parents "selling their children for science," Tishler says.

At the very least, Tishler advocates a more organized and large-scale effort to collect data on long-term side effects with children who are taking psychotropics. Anytime these medications are prescribed by a health-care provider, he or she should be required to complete an assessment for that child that discusses any side effects the child is experiencing — from sleep or appetite disturbance to any abnormalities in their blood work, Tishler says. "That way, these 8 million children could, in effect, be in a study."

Tishler also puts some of the onus on psychologists to help ensure that parents understand the risks these medications may pose, and work with a child's physician to develop care plans that don't revolve only around writing a prescription.

"My hope is that our article makes us think twice before sending someone off for a medication evaluation," he says. "We should try harder to consider psychological and behavioral treatments with the child and family first before looking to medicate."

—A. Novotney