Public Health Advisory
Suicidal Thinking in Children and Adolescents Being
Treated With Strattera (Atomoxetine)
Today the Food and Drug Administration
(FDA) directed Eli Lilly and Company (Lilly), the manufacturer of
Strattera (atomoxetine), to revise the labeling for this product to
include a boxed warning and additional warning statements that alert
health care providers to an increased risk of suicidal thinking in
children and adolescents being treated with this drug. FDA also
informed Lilly that it has determined that a Patient Medication
Guide (MedGuide), which will advise patients of the risks associated
with Strattera and precautions that can be taken, should be
distributed to patients when Strattera is dispensed.
Strattera is approved for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and
adult patients.
The increased risk of suicidal thinking
for this drug was identified in a combined analysis of 12 short-term
(6-18 weeks) placebo-controlled trials (11 in ADHD and 1 in enuresis
[bedwetting]). These 12 trials involved a total of over 2200
patients, including 1357 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 risk of suicidal thinking was about 4 per
thousand patients treated with Strattera compared to no events in
placebo-treated patients. There was 1 suicide attempt among these
approximately 2200 patients, occurring in a patient treated with
Strattera. Based on these data, FDA has determined that the
following points are appropriate for inclusion in the boxed warning:
- Strattera increases the
risk of suicidal thinking in children and adolescents with ADHD.
- Anyone considering the
use of Strattera in a child or adolescent for ADHD must balance
the increased risk of suicidal thinking with the clinical need for
the drug.
- Patients who are
started on therapy should be observed closely for clinical
worsening, suicidal thinking or behaviors, or unusual changes in
behavior.
- Families and caregivers
should be advised to closely observe the patient and to
communicate changes or concerning behaviors with the prescriber.
Pediatric patients being treated with
Strattera should be closely observed for clinical worsening, as well
as agitation, irritability, suicidal thinking or behaviors, and
unusual changes in behavior, especially during the initial few
months of a course of drug therapy, or at times of dose changes,
either increases or decreases. This monitoring should include daily
observation by families and caregivers and frequent contact with the
physician.
In addition a MedGuide is being
prepared for Strattera to provide directly to patients and their
families and caregivers information about the increased risk of
suicidal thinking in children and adolescents prescribed Strattera.
The MedGuide is intended to be distributed by the pharmacist with
each prescription or refill of a medication.
A similar analysis in adult patients
treated with Strattera for either ADHD or major depressive disorder
(MDD) found no increased risk of suicidal ideation or behavior with
use of Strattera.
FDA plans to work closely with Lilly to
optimize the safe use of this drug and implement the proposed
labeling changes and other safety communications in a timely manner.
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Date created: September 29, 2005 |