Atomoxetine (Strattera®, Eli Lilly and Company) a norepinephrine re-uptake inhibitor, is licensed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, in adolescents and adults. It was registered in Singapore in April 2005.

Eli Lilly and Company has issued a Dear Healthcare Professional Letter to alert our healthcare professionals of an increased risk of suicidal thinking in children and adolescents associated with the use of Strattera®.

This new findings emerged as part of a larger evaluation of psychiatric drugs and suicidality following the Food and Drug Administration's request to manufacturers to conduct a review of their database and clinical trials.

Eli Lilly and company reanalysed 12 clinical trials on Strattera® conducted in children with ADHD and 1 trial in children with enuresis. The review involved more than 2,200 patients, including 1,357 receiving Strattera® and 851 receiving placebo. The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera®. The average rate of suicidal thinking was about 0.4% in children treated with Strattera® compared to no events in children treated with placebo. There was 1 suicide attempt in these 2,200 patients which occurred in a patient on Strattera®. A similar analysis in adult patients treated with Strattera® for either ADHD or major depressive disorder found no increased risk of suicidal ideation or behaviour with the use of Strattera®. There were no completed suicides among children, adolescents, or adults on the medication during any Strattera® clinical trials.

Physicians are advised to carefully monitor patients on Strattera® for possible clinical worsening, as well as agitation, irritability, suicidal thinking or behaviours, and unusual changes in behaviour, especially during the initial few months of therapy or when the dose is increased or decreased. Patients, their families and caregivers should be informed of this risk. They should also closely observe the patient for signs and symptoms and communicate these to the physicians should they occur.