February 10, 2006 -- FDA Advised to Add 'Black Box' Warnings to Ritalin, Other Stimulants

An advisory panel to the federal Food and Drug Administration (FDA) said yesterday it is recommending that the FDA require manufacturers of widely prescribed stimulants such as Ritalin, Adderall, and Concerta to place the most serious type of warning on the drugs, to indicate they may increase the risk of strokes and cardiac arrhythmias in children and adults. The advisors cited reports of sudden deaths of people taking the drugs and suggested the stimulants may increase heart risks more than two-fold. Stimulants are widely used to reduce childhood behavioral problems such as attention deficit hyperactivity disorder (ADHD) and are increasingly being prescribed for adults; data presented to the advisory panel suggested that 2.5 million children and 1.5 million adults currently take them. Members of the advisory panel apparently agreed that a "black box" warning might prompt families to explore behavioral treatments as an alternative to drugs in controlling childhood ADHD, and they agreed that parents of children with pre-existing heart conditions should consult their doctors before giving stimulants. The FDA is not required to implement the recommendations of its advisory panels, but usually does so. FDA officials were said, however, to be "taken aback" by yesterday's recommendations, and it was not clear whether the suggested actions would be taken.