Alert for Healthcare
Professionals
Atomoxetine (marketed as Strattera)
FDA Alert [09/05]: 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
.
Recommendations
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.
Data Summary
The increased risk
of suicidal thinking for this drug in children and adolescents was
identified in a combined analysis of 12 short-term (6-18 weeks)
placebo-controlled trials (11 in ADHD and 1 in enuresis). 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. 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 the use of Strattera.
To
report any unexpected adverse or serious events associated with the
use of isotretinoin, please contact the FDA MedWatch program at
1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Approved Product Labeling
Additional Information
http://www.fda.gov/cder/drug/infopage/atomoxetine/default.htm
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/infosheets/patient/AtomoxetinePIS.pdf
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Atomoxetine
Date created: September 29, 2005 |