| MothWrangler 2005-09-30, 12:38 pm |
| From FDA news release (September 29, 2005)
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html:
FDA Issues Public Health Advisory on Strattera (Atomoxetine) for
Attention Deficit Disorder
The Food and Drug Administration (FDA) today is issuing a Public Health
Advisory to alert physicians of reports of suicidal thinking in children
and adolescents associated with Strattera, a drug approved to treat
attention deficit hyperactivity disorder (ADHD). FDA has also directed
Eli Lilly and Company, manufacturer of Strattera, to develop a
Medication Guide for patients and caregivers.
FDA is advising health care providers and caregivers that children and
adolescents being treated with Strattera should be closely monitored for
clinical worsening, as well as agitation, irritability, suicidal
thinking or behaviors, and unusual changes in behavior, especially
during the initial few months of therapy or when the dose is changed
(either increased or decreased). Patients and caregivers who have
concerns or questions about these symptoms should contact their
healthcare provider.
"FDA's action today is another example of the agency acting swiftly to
alert the public to significant drug safety information needed to use a
drug in a safe manner," said Dr. Steven Galson, Director for the Center
for Drug Evaluation and Research, FDA.
Today's actions follow a review and analysis of 12 clinical trials
conducted in children with ADHD and one trial in children with enuresis
(bedwetting) that identified an increased risk of suicidal thinking for
Strattera. There was one suicide attempt by a patient who received
Strattera among the approximately 2,200 patients in the trial. As part
of a larger evaluation of psychiatric drugs and suicidality, FDA had
requested that the manufacturer conduct a review of its database and
clinical trials, which included more than 2200 patients--1350 patients
receiving Strattera (atomoxetine) and 851 receiving a placebo. The
analysis showed that 0.4% of children treated with Strattera reported
suicidal thinking compared to no cases in children treated with the placebo.
Nancy
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