Pharmacy Times, Volume 0, 0

An FDA panel's recommendation to excludea "black-box" warning about possible psychiatricand cardiac risks associated with attention-deficit/hyperactivity disorder (ADHD)drugs contrasted with an earlier FDA committee'svote. Instead, the FDA's pediatric committeeproposed that the medications usesimpler language and include more informationon the labels.

In February 2006, a different FDA advisorycommittee had voted in favor of a black-boxwarning on ADHD drugs because of possiblecardiac risks. A black-box warning is the FDA'sstrongest alert, and it usually negatively affectsthe sales of drugs that carry the warning. TheFDA typically follows the recommendations ofits advisory committees.

Controversy surrounding ADHD drugs hasbeen brewing for some time. The increasednumber of patients taking these stimulantscontinues to surge. Eli Lilly's Strattera is nowrequired to carry a black-box warning that itmay trigger suicidal thoughts in children. In theUnited States, Adderall XR (Shire US Inc) carriesa warning informing patients with heartconditions not to use the drug.