Committee votes to add black box to ADHD drugs

February 20, 2006

The FDA Drug Safety and Risk Management Advisory Committee voted 8 to 7 in favor of adding a black box warning to the labeling of all stimulant drugs used to treat ADHD. The group also voted unanimously (15-0) in support of requiring that FDA medication guides be distributed with each stimulant prescription, explaining the potential risks to patients and their families.