About one in 100 preschoolers are being treated with stimulant drugs, such as Ritalin, for attention-deficit hyperactivity disorder (ADHD). However, Ritalin is not approved for 3- to 5-year-old children and few studies have been conducted with this age group. Ritalin has been shown to have serious side effects such as stunting physical development, heart problems, insomnia, changes in personality, cardiotoxicity and sudden death. Despite these side effects, some experts believe that Ritalin use is necessary in children with ADHD who are at high risk of physical harm. Now research conducted by the National Institute of Mental Health (NIMH) reports that Ritalin has a "moderate" effect on 3- to 5-year-old children, although the preschoolers were found to be more sensitive to side effects. The long-term risks of Ritalin use are not yet known.
The study, published in the Journal of the American Academy of Child and Adolescent Psychiatry, investigated the safety and effectiveness of Ritalin (methylphenidate) treatment on 3- to 5-year-old children with ADHD. NIMH researchers administered either generic Ritalin or a placebo to 183 children between the ages of 3 and 5, in four different phases for 70 weeks. The researchers recorded vital signs from the participants and adverse events from parents and teachers. The children's parents attended 10 two-hour ADHD training sessions and had the option to discontinue Ritalin treatment at any time.
The researchers found that Ritalin had positive effects in about 50 percent of the children. However, 30 percent of parents reported adverse events in their children including emotional outbursts, trouble sleeping, repetitive behaviors and thoughts, appetite loss, and irritability. Twenty-one children were discontinued from the drug due to adverse events. These results suggest that Ritalin was not as effective as seen in older children, and had more side effects.
"Eleven percent of preschoolers discontinued treatment because of intolerable methylphenidate adverse events," the study authors write. "Of the serious adverse events reported, one occurred in baseline, two in lead-in, three in titration, one in parallel, and one in maintenance. Only one was possibly related to methylphenidate."
REFERENCES:
1. Wigal T et al. Safety and tolerability of methylphenidate in preschool children with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-303.
Posted by Elaine Gavalas on November 29, 2006 02:51 PM
