WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

Strattera (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of Strattera (atomoxetine) in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Strattera (atomoxetine) is approved for ADHD in pediatric and adult patients. Strattera (atomoxetine) is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo controlled trials of Strattera (atomoxetine) in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Strattera (atomoxetine) compared to placebo. The average risk of suicidal ideation in patients receiving Strattera (atomoxetine) was 0.4% (5/1357) patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions (5.1)]