WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine hydrochloride 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 Atomoxetine hydrochloride in a child or adolescent must balance this risk with the clinical need. Comorbidities 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. Atomoxetine hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of Atomoxetine hydrochloride in children and adolescents (a total of 12 trials involving over 2,200 patients, including 11 trials in ADHD and one trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Atomoxetine hydrochloride compared to placebo. The average risk of suicidal ideation in patients receiving Atomoxetine hydrochloride was 0.4% (5/1,357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials. Atomoxetine hydrochloride capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. Important:!All pediatric patients being treated with Atomoxetine hydrochloride should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy or at times of dose changes, either increases or decreases.