Warnings added to ADHD drug label

NEWS IN BRIEF — Posted Sept. 18, 2006

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At the request of the Food and Drug Administration, warnings of possible cardiac and psychiatric adverse events have been added to the label of the drug dextroamphetamine, according to a letter issued by GlaxoSmithKline, the drug's manufacturer.

The agency took this action after two advisory committees met earlier this year and recommended adding such warnings to the information accompanying stimulant drugs used to treat attention-deficit/hyperactivity disorder. The agency decided against a black-box warning.

The label for this drug now warns that misuse can lead to sudden death and serious cardiovascular disease. Usual use also can lead to similar adverse events in those who have preexisting cardiac issues. The label advises that physicians asses patients' heart health before prescribing and evaluate promptly if symptoms of heart trouble develop.

The new label also warns that these drugs can exacerbate preexisting psychological problems, increase the risk of seizures and suppress growth in some children.

Note: This item originally appeared at

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