Is a Black Box Warning Appropriate?
• NAMI’s position is that the FDA Drug Safety & Risk Management Advisory Committee (the February 2006 committee) recommendation that a black box warning be added to the labeling of ADHD medications was premature. NAMI takes this position given the lack of clear evidence linking ADHD medications to serious adverse cardiac events or sudden death. • The Black Box Warning raises more questions than it answers. • NAMI calls for an immediate, transparent review of the relevant data. Specifically NAMI seeks a comparison of data showing the risks associated with not taking the medications to data showing the risks of serious and rare adverse cardiac events and sudden death among youth and adults with ADHD who take these medications. • Adults with ADHD and families of children living with this serious disorder need to understand this risk ratio so they can make informed decisions, in consultation with their treating provider, about the appropriate use of medications to treat ADHD.
