ADHD Drugs Not to Get "Black Box" Warning

March 2006

A federal advisory panel came to the conclusion that drugs used to treat attention deficit hyperactivity disorder (ADHD) do not need to carry a “black-box” warning, the government’s strongest, alerting users of psychiatric and cardiovascular risks.

However, the Food and Drug Administration (FDA) pediatric advisory committee determined the drug labels should highlight the possible dangers in plain language easily understood by patients. The updated labels may not appear until companies begin using a newly adopted format that may take several years to put into effect.

Still, the FDA could decide to require “black-box” warnings on drugs used to treat ADHD that would alert adults of the increased risk of heart attack, stroke, and other serious problems.

Psychiatrists and other experts asked the committee to be cautious before recommending strengthened warnings associated with ADHD drugs. They felt adding the “black-box” warning would cause more harm than good.

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