"Black-Box" warnings

In an article on Wednesday, March 22, it was reported that the advisory committee of the FDA's Drug Safety and Risk Management voted to recommend putting a "black-box" warning on ADHD medication, providing any warnings to possible side effects the drugs may pose to the cardiovascular system. Although it has not been proven, there are suspicions that certain side effects may be caused by ADHD medications like Ritalin and Adderall. In several trials, children were taken off of their medication and the "similar reports" found among had ceased. However, when they resumed the dosage, some of the "reports" returned. Nothing is being said for certain, but the reports are being thoroughly examined. Today a third panel for the FDA is reviewing an application by Cephalon Inc. to sell their sleep-disorder drug, Provigil, as ADHD treatment.

Ritalin, or methylphenidate, is a common medication in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). The disorder is characterized by "abnormally high levels of activity, impulsivity, and/or inattention that is more frequently displayed and more severe than is typically observed in individuals with comparable levels of development." The disease is often diagnosed between three and five years of age. Today, nearly three to seven percent of school-age children have been diagnosed with ADHD. Because Ritalin is a central nervous system stimulant, it is been reported that many have abused the medication without a prescription. There have been controversies over the use of Ritalin in children of such young age with ADHD.