STRATTERA CARDIOVASCULAR CONSIDERATIONS

All medications for the treatment of ADHD are sympathomimetic. The stimulatory effects from these drugs on the sympathetic nervous system are usually mild or moderate, but in patients of all ages, particularly those with cardiovascular compromise, these effects may result in serious adverse events including sudden/cardiac death.

· STRATTERA should be used with caution in patients with hypertension, tachycardia, congenital long QT syndrome, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate.

· STRATTERA-treated adult subjects experienced mean increases in systolic (about 3 mm Hg) and diastolic (about 1 mm Hg) blood pressures compared with placebo.

· Sudden death has been reported in association with stimulant drugs used for ADHD treatment at usual doses in children with structural cardiac abnormalities. Although STRATTERA is not a stimulant drug, it should not generally be used in children, adolescents, or adults with known structural cardiac abnormalities.

· All drugs with sympathomimetic effects prescribed in the management of ADHD should be used with caution in patients who: a) are involved in strenuous exercise or activities, b) use stimulants, or c) have a family history of sudden/cardiac death.

· QTc prolongation was reported in two cases of intentional atomoxetine overdose which may have involved other drugs (bupropion, risperidone, quetiapine).