Strattera - Warnings & Precautions

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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.)

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.