Study Sparks Debate on Ritalin Use in Preschoolers

A new national study that raises the possibility of preschoolers with attention-deficit hyperactivity disorder taking Ritalin has sparked a debate over the safety and appropriateness of such a practice.

"This drug doesn't work as well in preschoolers as it does in older kids, and there are more adverse effects and a higher drop-out rate in this group," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "In addition, there is an explicit statement [in the study] saying that the size of this study is too small to conclude that this drug is safe and, to me, that is as important as anything."

The National Institute of Mental Health (NIMH), which funded the study, however, says the drug might be useful in certain severe cases of attention-deficit hyperactivity disorder (ADHD).

"Going into this, we had no data with which to know whether the medication was effective or safe, and what we know coming out of it is that there is some evidence of benefit in this young age group, but less than what we see with older children, and the risks are somewhat greater," said NIMH Director Dr. Thomas Insel. "We are recommending to clinicians and families that the drug should be considered as one of many options that can be used in very young children with severe ADHD, and I underline severe. If it's going to be used, it needs to be used carefully with careful monitoring," he added.

Others agreed that Ritalin should be considered on a case-by-case basis. "It is well known that ADHD has its onset usually between 3 to 4 years of age, so it is only reasonable if behavioral and psychosocial interventions fail that we consider the use of psychostimulants such as Ritalin, as this intervention is successful at least 70 percent of the time," said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami Miller School of Medicine. "It's a cost/benefit decision that parents have to judiciously consider, weighing the risk of side effects and the benefits of helping a child to control himself/herself."

Ritalin (methylphenidate) is used to treat ADHD but is not approved for children under the age of 6, although Insel said that about 1.2 percent of preschool kids are already receiving the drug. Such "off-label" prescribing is not illegal.

Even in older children, the drug has had its share of controversy. The U.S. Food and Drug Administration pediatric advisory committee recently met to consider whether ADHD drugs including Ritalin should carry a black box warning to highlight the possible risks of psychosis, mania and cardiovascular problems. In the end, the committee voted against a black-box warning but recommended the label use simpler language and include more information.

According to the Associated Press, about 8 percent of U.S. children have ADHD, including around 3 percent of preschoolers.

The study that sparked the latest controversy is the first, long-term government trial of Ritalin in preschoolers and is in the November edition of the Journal of the American Academy of Child and Adolescent Psychiatry.

Several of the study's authors have financial ties with companies that make the drugs.

The Los Angeles Times reported that the trial was initiated in response to the outcry that ensued when the Journal of the American Medical Association claimed that as many as 200,000 preschoolers were taking Ritalin off-label.

The trial involved 183 children with severe cases of ADHD who took Ritalin for about a year. Thirty percent of parents reported moderate to severe adverse events in their children, including emotional outbursts, difficulty sleeping, decreased appetite and irritability. About 11 percent of children dropped out because of side effects.

The preschoolers taking the drug also grew about a half inch less and gained about two pounds less than expected for their age.

Improvements in behavior were seen in children taking 7.5 to 30 milligrams daily, with the optimal dose being 14 milligrams daily. That is less than half the usual dose for older children.

The size of the study was a major sticking point for critics. "If you're worried about some serious adverse effects, you'd never see it in 183 kids," Wolfe said. "They specifically say this should be studied in at least 1,500 kids, which is seven times more than it was."

"Is there enough evidence for this drug to be approved for this group of preschool children for which it is currently not approved? The answer is clearly no. The authors themselves say no," he continued. "People should be extremely careful about giving this to young kids."

Insel said he suspected the drug's maker would not seek approval for this indication. "It's being used so widely, I don't know that they need to do any marketing," he added.

Insel also said he did not believe the study was that small and that, in fact, investigators had gone into the trial feeling that it would show that the drug should not be used. "The evidence does not bear that out," he said.

But long-term follow-up still needs to be done.

"What we don't know, and I think this is critical for parents, is what the long-term issues are," Insel said. "Are we altering brain development or is this a case in which the natural course of brain development has already been altered by a disorder, and we're in some ways mitigating those effects? We will need long-term follow-up, and that's in the works."