Atomoxetine, a Novel Treatment for Attention-Deficit-Hyperactivity Disorder

Alisa K. Christman, Pharm.D.; Joli D. Fermo, Pharm.D.; John S. Markowitz, Pharm.D.


Pharmacotherapy. 2004;24(8) 

In This Article

Precautions and Contraindications

Based on the pharmacologic effects of increased levels of norepinephrine in the body, atomoxetine should be used with caution in patients who have hypertension, tachycardia, or any other significant cardiovascular or cerebrovascular disease because of its effects on increasing blood pressure and pulse. In clinical studies performed in children, adolescents, and adults, the quantitative increases in blood pressure observed were clinically insignificant for systolic and diastolic blood pressure and pulse.[23,24,27] Any increases were sustained within 1 year from baseline to end point, with a mean systolic increase of 3.6 mm Hg and a mean diastolic increase of 3.5 mm Hg.[16] Mean increase in the pulse during 1 year was 3.9 beats/minute.[16] As treatment continued, the increased changes in blood pressure ceased to occur. Once atomoxetine was discontinued, the blood pressure quickly returned to baseline.[6,23,24,34]

Regarding electrocardiographic changes, no statistically significant changes were reported. Trials evaluating the increases in blood pressure and pulse in adults indicated that moderate increases from baseline to end point were not found to be clinically significant. In clinical trials involving adult patients with ADHD, mean increases in pulse in subjects treated with atomoxetine occurred at about 5 beats/minute more compared with the mean pulse rate of placebo-treated subjects. The frequency of clinically observed tachycardia was about 3% and 0.8% in atomoxetine- and placebo-treated groups, respectively, and was dose dependent.[16] The increases in pulse observed subsided on discontinuation of atomoxetine. Mean increases in blood pressure were about 1.5 mm Hg in systolic and diastolic blood pressures in pediatric atomoxetine-treated patients and about 3 mm Hg in systolic and about 1 mm Hg in diastolic blood pressures in adult atomoxetine-treated patients. Systolic measurements greater than 150 mm Hg were not found to be statistically significant and occurred at a rate of 1.9% and 1.2% in subjects treated with atomoxetine versus placebo, respectively.[16]

In trials evaluating the effects of atomoxetine in adults with ADHD, the rate of urinary retention or hesitation was 3% in a sample of 269 atomoxetine-treated patients versus 0% in the placebo group.[16] Therefore any complaint of urinary retention or hesitancy should be considered possibly related to atomoxetine.