The use of psychotropic prescription drugs to treat attention-deficit/hyperactivity disorder (ADHD), mood disorders, anxiety, and other mental health disorders in very young children appears to be leveling off, according to a report published today.

A national study of more than 43,000 children aged 2 to 5 years found that overall psychotropic prescription use peaked in the mid-2000s, then stabilized in the late 2000s.

However, bucking the trend for decreased use, the study found that boys, white children, and those lacking private health insurance had an increased likelihood of psychotropic drug use during the entire 16-year study period.

The study from researchers at Cincinnati Children's Hospital in Ohio was published online September 30 in Pediatrics.

Result of FDA Warnings?

Previous studies have documented 2- to 3-fold increases in psychotropic prescriptions for US preschool children during 1991 and 2001, even though few psychotropic medications are approved by the US Food and Drug Administration (FDA) for this age group, the researchers note.

To examine national trends in psychotropic medication use in 2- to 5-year-olds, they analyzed data for 1994 to 2009 from the National Ambulatory and National Hospital Ambulatory Medical Care Surveys, which collect data on office- and hospital-based physician visits in the United States.

"The likelihood of receiving a behavioral diagnosis increased in 2006 to 2009, but this was not accompanied by an increased propensity toward psychotropic prescription," Tanya Froehlich, MD, the study's senior author, said in a statement.

"In fact, the likelihood of psychotropic use in 2006 to 2009 was half that of the 1994 to 1997 period among those with a behavioral diagnosis," she noted.

Specifically, psychotropic drug use decreased from 43% of those with 1 or more behavioral diagnoses from 1994-1997 to 29% from 2006-2009, the researchers say.

This decrease may be the result of several warnings issued by the FDA in the mid- to late-2000s, they suggest. Chief among them, a 2004 black box warning on antidepressant medications concerning suicide risk among children and adolescents; a 2005 black box warning on atomoxetine (Strattera, Eli Lilly and Company) regarding potential sudden death and suicidal ideation; a 2006 FDA Advisory Committee recommendation for a black box warning on psychostimulants (which was later reversed); and a 2007 directive to ADHD medication manufacturers to notify patients about adverse cardiovascular events and psychiatric symptoms.

Prescribe With Caution

The researchers note that additional research is warranted to figure out why boys, white children, and those lacking private health insurance had an increased likelihood of psychotropic drug use during the study period and to determine the appropriateness of these prescriptions.

Commonly prescribed psychotropic drugs fall into several categories, including both typical and atypical antipsychotics, antidepressants, antianxiety agents, stimulants, and mood stabilizers.

"Our findings underscore the need to ensure that doctors of very young children who are diagnosing ADHD, the most common diagnosis, and prescribing stimulants, the most common psychotropic medications, are using the most up-to-date and stringent diagnostic criteria and clinical practice guidelines," Dr. Froehlich said.

"Furthermore, given the continued use of psychotropic medications in very young children and concerns regarding their effects on the developing brain, future studies on the long-term effects of psychotropic medication use in this age group are essential," she added.

The study was supported by the National Institute of Mental Health. The authors have disclosed no relevant financial relationships.

Pediatrics. Published online September 30, 2013. Abstract