The FDA has asked GlaxoSmithKline to add a label warning about the risk of heart problems for patients taking the prescription drug dextroamphetamine sulfate (Dexedrine), a stimulant used to treat attention-deficit/hyperactivity disorder (ADHD).
The FDA has received reports of sudden death among children and teenagers who had heart problems and who took Dexedrine.
In May 2006, the FDA had asked the makers of similar stimulant ADHD drugs to add the warnings. In March, an FDA advisory committee had recommended that ADHD drugs not carry the more severe boxed warnings but that simpler language be used and more information be included about heart risks. However, a month earlier, a different committee had called for a boxed warning on ADHD drugs because of possible cardiac risks. The FDA has apparently settled for the less severe advisory.
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The warnings issued since last spring also cite possible suppression of growth and a heightened risk for psychosis, bipolar illness, and aggression. It is unclear whether other ADHD drugs might be affected by this new warning.
The new warning, it is hoped, should remind clinicians to review the side-effect profiles of medications. Dexedrine is in an older class of stimulants. Whether other ADHD drugs must also add new labeling remains to be seen.