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FDA Warning On ADHD Medications: Talking Points

March 23, 2006

On March 22, 2006, the U.S. Food & Drug Administration (FDA) Pediatric Advisory Committee recommended that medications for attention deficit hyperactivity disorder (ADHD) should not carry strong "black-box" warnings about potential cardiovascular and psychiatric risks. Instead, they recommended that drug labels include clearer warning labels.

The consensus recommendation, which the FDA is expected to follow, rejected the more severe "black-box" option that had been recommended by a different committee in February 2006. NAMI Medical Director Ken Duckworth submitted a written statement to the advisory committee for their consideration in reaching the decision. Key NAMI concerns include:

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.

Barriers to Treatment of ADHD:

  • The stigma associated with the diagnosis of ADHD
  • A crisis level shortage of children's mental health providers
  • Discriminatory caps on mental health coverage
  • Consumer and family systems that are fragmented and lack accountability: in short, a system in "shambles," as the President's New Freedom Commission has noted
  • A flawed health care delivery system that forces medical professionals to rush through patient visits

Consequences of Mistreated/Untreated ADHD:

  • Untreated or inappropriately treated ADHD often yield dire consequences it interferes with school and job performance and with relationships, and it raises the risk of substance abuse.

NAMI Calls to Action:

Federal, state and local leaders must help end these crises. NAMI will continue to recommend essential reforms that should immediately be undertaken, such as:

  • The mental health treatment system must use evidence-based assessment and intervention.These approaches would require clinicians to improve care continually by using the most current evidence to make decisions about the most appropriate care for people with ADHD and other mental illnesses.
  • We must correct the current deficit of medical professionals qualified to diagnose and properly treat children and adolescents with ADHD.
  • NAMI supports efforts to protect children from inaccurate diagnoses by ensuring that health care providers are better informed than they are now as to the proper diagnosis and safe and effective treatment for all mental illnesses.

NAMI Applauds a New FDA Guide:

NAMI applauds the FDA releasing a new medication guide to be distributed along with ADHD medication.  This guide will provide consumers with the needed education on the medication prescribed to treat their ADHD.


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