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Atomoxetine
General information
Atomoxetine is a non-stimulant noradrenaline reuptake inhibitor that is efficacious in the treatment of ADHD [ ]. Sudden deaths of children and adolescents taking Adderall XR® have led to the need to screen children for risks of heart defect before beginning this stimulant medication. The label for atomoxetine has been altered to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents treated with this medication.
An association of ADHD and completed suicide, particularly in adolescent males, has been reported [ ]. However, there is little evidence to suggest a direct link. Rather, co-morbidities (such as mood disorders, conduct disorder, and substance abuse) that are commonly associated with ADHD may lead to an increased risk of completed suicide, and may be related to increased suicidal ideation in patients taking atomoxetine.
Drug studies
Systematic reviews
The efficacy and safety of atomoxetine in children and adolescents have been evaluated in a systematic review of nine randomized placebo-controlled trials [ ]. Atomoxetine (n = 1150) was superior to placebo (n = 678) in reducing ADHD symptoms. The NNTB values for treatment response and relapse prevention were 3.43 (95% CI = 2.79, 4.45) and 10.3 (95% CI = 5.89, 40.62) respectively. The commonest adverse events were gastrointestinal (reduced appetite, NNTH = 9; abdominal pain, NNTH = 22; vomiting, NNTH = 30; dyspepsia, NNTH = 49) and somnolence (NNTH = 19). Young age and high baseline hyperactive/impulsive symptoms were associated with more adverse events, and ADHD inattentive subtype was associated with fewer adverse events.
Organs and systems
Cardiovascular
Since atomoxetine is a selective noradrenaline transport blocker, it could cause increased blood pressure by increasing noradrenaline concentrations in peripheral sympathetic neurons, an effect that could be masked in healthy subjects by central sympatholytic mechanisms. The pressor effect of atomoxetine 18 mg has been studied in 21 patients with impaired central (n = 10) and peripheral (n = 11) autonomic nervous system function in a randomized, crossover, placebo-controlled study [ ]. Atomoxetine acutely increased sitting and standing systolic blood pressure in patients with central autonomic impairment by 54 and 45 mmHg respectively compared with placebo. However, in those with peripheral autonomic impairment, atomoxetine had no pressor effect. The authors proposed that this suggests that a functional central sympatholytic pathway is essential to avoid hypertension in patients taking atomoxetine. They suggested caution when atomoxetine is used in patients with autonomic impairment.
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