Risk of Suicidality in Children Treated w Strattera (Dec 05)

FDA recently alerted health care providers that treatment of children and adolescents with Strattera increases the risk of suicidal thinking. Strattera (atomoxetine) is approved to treat ADHD in patients 6 years and older.

The increased risk of suicidal thinking was identified in a combined analysis of 12 placebo-controlled trials lasting six to eighteen weeks. This analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no reports in children treated with placebo. A similar analysis in adults treated with Straterra for either ADHD or major depressive disorder found no increased risk of suicidality with use of the drug.

A new boxed warning will point out that children who are started on Strattera therapy should be observed closely for suicidal thinking or behaviors, clinical worsening, or unusual changes in behavior. This is especially important during the initial months of therapy or when the dose is changed.

Families should contact their child's doctor if they observe any of these signs.
Eli Lilly, the drug's manufacturer, will also be developing a Patient Medication Guide to provide this information directly to patients and their caregivers.