FDA Alert [9/2005]:  Suicidal Thinking in Children and Adolescents

The Food and Drug Administration (FDA) directed Eli Lilly (Lilly) to revise the labeling for Strattera 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.  In addition, a Medication Guide will be prepared to provide directly to patients, their families, and caregivers information about the risks mentioned above.  The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of a medication.

Strattera is currently approved in the United States to treat ADHD in children, adolescents, and adults.  Strattera has not been studied in children under 6 years of age.    

This information reflects FDA’s current analysis of data available to FDA concerning this drug.  FDA intends to update this sheet when additional information or analyses become available.