FDA panel opposes ADHD black boxes

An FDA advisory committee Wednesday recommended against adding black box warnings to pediatric ADHD drugs. The Pediatric Advisory Committee recommended that the labels note that ADHD drugs are associated with a rare incidence of psychosis and mania in children. The labels should also tell physicians and parents to watch for the emergence of aggression, according to the committee. The panel suggested retaining the current black box warning about suicidality on the label of Strattera atomoxetine from Eli Lilly (LLY) but said there are no data to suggest the risk applies to other approved ADHD drugs. ...