Public Advisory: Strattera and Childhood/Teenage Suicide Link

The Food and Drug Administration directed Strattera maker Eli Lilly to revise the labeling to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug.

The following points are appropriate for inclusion in the boxed warning about the link between children and teens tendency for suicide and Strattera: The unsafe drug increases the risk of suicidal thinking in children and adolescents with ADHD. Doctors must balance the increased risk of suicidal thinking with the clinical need for Strattera. Teens and children who are started on Strattera therapy should be observed for clinical worsening, suicidal thinking, or unusual changes in behavior. Parents and caregivers should be advised to closely observe children and teens who have been prescribed Strattera and to immediately note changes with their doctor. (FDA)