FDA committee recommends black box warning for ADHD drugs.(Food and Drug Administration)(Attention-deficit/hyperactivity disorder )

Black box warnings may soon be added to the labeling of drugs used to treat attention-deficit/hyperactivity disorder (ADHD). The new, stronger warnings would caution patients and prescribers of the possible increased risk of serious cardiovascular events in children and adults. If the new labeling is implemented, it comes in response to a non-binding recommendation issued on February 9, 2006 by the Food and Drug Administration's (FDA's) Drug Safety and Risk Management Advisory Committee.

The new recommendation, which has sparked controversy among professional organizations and the scientific community, follows post-marketing safety data reported to the FDA documenting sudden death and serious adverse events (SAEs) in children and adults with therapeutic doses of ADHD drugs. Among patients using methylphenidate and amphetamine, 25 deaths were reported to the FDA between 1999 and 2003, 19 of which were deaths in children under the age of 18 years. While all of the deaths occurred during ADHD drug therapy, some …