Study looks at risk of Ritalin in preschoolers with ADHD

In the first long-term government study of Ritalin use in preschool-age children, the findings warn of side effects but also benefits in children with severe cases.

The drug is not approved for use in children under age 6, and the researchers said those youngsters need close monitoring. Preschoolers are more likely to develop side effects than older children, according to experts.

There were benefits for children with severe cases of ADHD, but the researchers said preschoolers on Ritalin need close monitoring because they are more likely than older children to develop side effects.

The research was done because of concerns over reports that the numbers of preschoolers being given psychiatric drugs like Ritalin are soaring.

Dr. Thomas Insel, director of the National Institute of Mental Health NIMH) called the study’s message “proceed with caution.”

“We’re not talking about fidgety 3-year-olds,” he said. The NIMH funded the study.

The research involved children with severe attention deficit hyperactivity disorder (ADHD) with behaviors that included hanging from ceiling fans, playing with fire or jumping off slides. The researchers say the benefits of low-dose treatment outweigh the risks for these children. Critics, however, disputed that.

Dr. Sidney Wolfe of the watchdog group Public Citizen said, “I hope publication of this does not lead to more overprescribing. The safety isn’t adequately established, the efficacy even less.”

Around 40% of children developed side effects and approximately 11% dropped out because of problems including weight loss, irritability, insomnia and slowed growth.

Preschoolers on methylphenidate, or generic Ritalin, grew about half an inch less and gained about 2 pounds less than expected during the 70-week study.

Dr. Peter Breggin, a longtime critic of psychiatric drug use in children, called the findings “a catastrophe” and said, “It just opens up the way for drugging the younger kids.”

He said the research is part of a marketing push by the drug industry to expand drug use to the youngest children.

Around 8% of children in America have ADHD, including roughly 3% of preschoolers. Previous research found that about 1 in100 preschoolers had been prescribed Ritalin, which ahs only been approved for use in children over age 6. Use in younger children is not illegal, but considered an “off-label” usage.

University of Vermont psychiatry professor Dr. David Fassler said the study does a good job of outlining pros and cons of Ritalin treatment in preschoolers.

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“This is exactly the kind of information we need to help parents make informed decisions about treatment options for young children with ADHD,” he said.

The study, which will be published in the November 2006 edition of the Journal of the American Academy of Child and Adolescent Psychiatry, included 10 weeks of behavioral treatment along with parent training and about one year of drug treatment. Almost 300 families were enrolled, but many withdrew after the initial phase, either due to success with the behavior treatment or because they did not want to put their children on drugs.

The drug phase began with 165 children, and more than a dozen dropped out because of side effects.

Behavior improvements were seen in children taking 7.5 to 30mg/day, but the optimal dose was 14 milligrams daily – less than half the normal Ritalin dose for older children, Greenhill said.

SOURCES: Dr. Thomas Insel, director, National Institute of Mental Health. Dr. Sidney Wolfe, MD, Public Citizen watchdog group. Dr. Peter Breggin, MD, New York, USA. Dr. Laurence Greenhill, MD, Columbia University, New York State Psychiatric Institute, New York, USA. Dr. David Fassler, MD, psychiatry professor, University of Vermont, USA.

© Copyright 2007 Insight Journal Online Magazine.

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