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FDA Panel Recommends Against Black Box Warnings For ADHD Medications

March 24, 2006

On March 22, 2006, the U.S. Food & Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) recommended against requiring "black-box" warnings about potential risks associated with the use of stimulants to treat Attention Deficit Hyperactivity Disorder (ADHD). Instead, the panel recommended that these drugs should include clear warnings that stimulants lead a small number of children to experience hallucinations and mania. 

In February, another FDA panel, in an eight to seven vote recommended that the FDA require a Black Box warning for ADHD medications based on rare and serious cardiac risks and sudden death.  That prompted the PDAC’s meeting on March 22 that included a review of this recommendation as well as potential psychiatric side effects. 

NAMI medical director Ken Duckworth provided written testimony to PDAC to aid it in its deliberations.  This testimony can be viewed on the NAMI Web site.    The PDAC reviewed data and research related to the safety, efficacy and risks of ADHD medications and declined to require a Black Box warning.  

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