Concerta safe for children with ADHD and epilepsy

By Martha Kerr

CHICAGO (Reuters Health) - Children with both attention-deficit attention disorder (ADHD) and epilepsy may safely take Concerta, a once-a-day formulation of methylphenidate, a team from Boston's Children's Hospital and Harvard University told the American Neurological Association meeting being held here this week.

Children with ADHD have a high risk of epilepsy, but studies of immediate-release methylphenidate have yielded conflicting results in children with both conditions. There have been no studies of the safety of an extended-release formulation such as Concerta, principal investigator Dr. Alcy Torres told Reuters Health.

This randomized, double-blind, placebo-controlled, crossover trial involved 27 children, mean age 10 years, with ADHD and epilepsy and who had been seizure-free with anti-epilepsy medication for at least one month prior to enrollment.

Patients received 18 mg, 36 mg or 54 mg Concerta for one week, and then crossed over to another arm of the study.

"The addition of Concerta is safe...it did not induce seizures," Torres said. "There were no serious adverse events" and all minor events resolved within 48 hours of drug discontinuation.

Adverse events associated with placebo were essentially the same as with active treatment, Torres noted.

Approximately 40 percent of children responded to the 18 mg dose, approximately 50 percent responded to the 36 mg dose and 75 percent of children responded to the 54 mg dose.

The Harvard researchers are applying for an expansion in the labeling of Concerta. They are also conducting a similar study with the non-stimulant Strattera in this patient population.

"This is what most practitioners are doing anyway," Torres commented.