Strattera

[atomoxetine HCl]

In adult placebo-controlled trials, STRATTERA-treated subjects experienced a mean increase in heart rate of 5 beats/ minute compared with placebo subjects. Tachycardia was identified as an adverse event for 3% (8/ 269) of these adult atomoxetine subjects compared with 0.8% (2/ 263) of placebo subjects.

STRATTERA-treated adult subjects experienced mean increases in systolic (about 3 mm Hg) and diastolic (about 1 mm Hg) blood pressures compared with placebo. At the final study visit before drug discontinuation, 1.9% (5/ 258) of STRATTERA-treated adult subjects had systolic blood pressure measurements 150 mm Hg compared with 1.2% (3/ 256) of placebo subjects. At the final study visit before drug discontinuation, 0.8% (2/ 257) of STRATTERA-treated adult subjects had diastolic blood pressure measurements 100 mm Hg compared with 0.4% (1/ 257) of placebo subjects. No adult subject had a high systolic or diastolic blood pressure detected on more than one occasion.

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Orthostatic hypotension has been reported in subjects taking STRATTERA. In short-term, child-and adolescent-controlled trials, 1.8% (6/ 340) of STRATTERA-treated subjects experienced symptoms of postural hypotension compared with 0.5% (1/ 207) of placebo-treated subjects. STRATTERA should be used with caution in any condition that may predispose patients to hypotension. Effects on urine outflow from the bladder — In adult ADHD controlled trials, the rates of urinary retention (3%, 7/ 269) and urinary hesitation (3%, 7/ 269) were increased among atomoxetine subjects compared with placebo subjects (0%, 0/ 263). Two adult atomoxetine subjects and no placebo subjects discontinued from controlled clinical trials because of urinary retention. A complaint of urinary retention or urinary hesitancy should be considered potentially
related to atomoxetine.

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