Study Warns of Side Effects For Preschoolers Taking Ritalin

Study Warns of Side Effects
For Preschoolers Taking Ritalin

Associated Press
October 20, 2006 11:40 a.m.

A new study suggests that preschoolers may be more prone to side
effects from Ritalin, a popular drug for attention-deficit disorder.

There were benefits for children who had severe ADHD, researchers
said, but children under the age of six on Ritalin need close
monitoring due to their increased risk for side effects compared to
older children.

The study was the first long-term government study of the drug's
effects on children of that age group and was prompted by reports of
the soaring number of preschoolers that are being given psychiatric
drugs, including Ritalin.

The study's message is "proceed with caution" said Thomas Insel,
director of the National Institute of Mental Health. "We're not
talking about fidgety three-year-olds," said Dr. Insel, whose agency
funded the study.

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

But critics disputed that. "I hope publication of this does not lead
to more overprescribing," said Sidney Wolfe of the watchdog group
Public Citizen. "The safety isn't adequately established, the efficacy
even less."

About 40% of children developed side effects and roughly 11% dropped
out because of problems including irritability, weight loss, insomnia
and slowed growth. Preschoolers on methylphenidate, or generic
Ritalin, grew about half an inch less and gained about two pounds less
than expected during the 70-week study.

"This is a catastrophe. It just opens up the way for drugging the
younger kids," said Peter Breggin, a New York psychiatrist and
longtime critic of psychiatric drug use in children. Dr. Breggin said
the research is part of a marketing push by the drug industry to
expand drug use to the youngest children.

The study appears in the November edition of the Journal of the
American Academy of Child and Adolescent Psychiatry. Several of the
researchers have financial ties to makers of ADHD drugs, including
Ritalin.

Lead author Laurence Greenhill, a psychiatrist with Columbia
University and New York State Psychiatric Institute, has been a paid
speaker for most companies that make the drugs.

Roughly 8% of U.S. children have ADHD, including around 3% of
preschoolers. Previous research found that about one in 100
preschoolers had been prescribed Ritalin, which has only been approved
for use in children aged six and older. Use in younger children is
considered "off-label" but is not illegal.

David Fassler, a psychiatry professor at the University of Vermont,
said the study does a good job of outlining pros and cons of Ritalin
treatment in preschoolers. "This is exactly the kind of information we
need to help parents make informed decisions about treatment options
for young children with ADHD," Dr. Fassler said.

The study involved 10 weeks of behavioral treatment including parent
training, then 70 weeks of drug treatment. Nearly 300 families were
enrolled but many dropped out after the first phase, either because
the behavior treatment worked or because they didn't want to put their
children on drugs. The drug phase started with 165 children, more than
a dozen dropped out because of side effects.

Behavior improvements were seen in children taking 7.5 to 30
milligrams daily, but the optimal dose was 14 milligrams daily -- less
than half the usual Ritalin dose for older children, Dr. Greenhill
said.

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Yes, I think the findings are helpful in that they show that Ritlain works,
but doctors and families need to be very cautious.

Jeff