Published Online: Monday, May 1, 2006

An FDA panel's recommendation to exclude a "black-box" warning about possible psychiatric and cardiac risks associated with attention- deficit/hyperactivity disorder (ADHD) drugs contrasted with an earlier FDA committee's vote. Instead, the FDA's pediatric committee proposed that the medications use simpler language and include more information on the labels.

In February 2006, a different FDA advisory committee had voted in favor of a black-box warning on ADHD drugs because of possible cardiac risks. A black-box warning is the FDA's strongest alert, and it usually negatively affects the sales of drugs that carry the warning. The FDA typically follows the recommendations of its advisory committees.

Controversy surrounding ADHD drugs has been brewing for some time. The increased number of patients taking these stimulants continues to surge. Eli Lilly's Strattera is now required to carry a black-box warning that it may trigger suicidal thoughts in children. In the United States, Adderall XR (Shire US Inc) carries a warning informing patients with heart conditions not to use the drug.

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