Strattera

[atomoxetine HCl]

PRECAUTIONS

General Effects on blood pressure and heart rate

— STRATTERA should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate. Pulse and blood pressure should be measured at baseline, following STRATTERA dose increases, and periodically while on therapy. In pediatric placebo-controlled trials, STRATTERA-treated subjects experienced a mean increase in heart rate of about 6 beats/ minute compared with placebo subjects. At the final study visit before drug discontinuation, 3.6% (12/ 335) of STRATTERA-treated subjects had heart rate increases of at least 25 beats/ minute and a heart rate of at least 110 beats/ minute, compared with 0.5% (1/ 204) of placebo subjects. No pediatric subject had a heart rate increase of at least 25 beats/ minute and a heart rate of at least 110 beats/ minute on more than one occasion.

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Tachycardia was identified as an adverse event for 1.5% (5/ 340) of these pediatric subjects compared with 0.5% (1/ 207) of placebo subjects. The mean heart rate increase in extensive metabolizer (EM) patients was 6.7 beats/ minute, and in poor metabolizer (PM) patients 10.4 beats/ minute. STRATTERA-treated pediatric subjects experienced mean increases of about 1.5 mm Hg in systolic and diastolic blood pressures compared with placebo. At the final study visit before drug discontinuation, 6.8% (22/ 324) of STRATTERA-treated pediatric subjects had high systolic blood pressure measurements compared with 3.0% (6/ 197) of placebo subjects. High systolic blood pressures were measured on 2 or more occasions in 8.6% (28/ 324) of STRATTERA-treated subjects and 3.6% (7/ 197) of placebo subjects.

At the final study visit before drug discontinuation, 2.8% (9/ 326) of STRATTERA-treated pediatric subjects had high diastolic blood pressure measurements compared with 0.5% (1/ 200) of placebo subjects. High diastolic blood pressures were measured on 2 or more occasions in 5.2% (17/ 326) of STRATTERA-treated subjects and 1.5% (3/ 200) of placebo subjects. (High systolic and diastolic blood pressure measurements were defined as those exceeding the 95 th percentile, stratified by age, gender, and height percentile -National High Blood Pressure Education Working Group on Hypertension Control in Children and Adolescents.)

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