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.