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Escitalopram
oxalate
(marketed as Lexapro) Information
Historical Information
Previous FDA Alert – Suicidal
Thoughts or Actions in Children and Adults [Issued 7/2005]
7/2006: The issues described
below have been
addressed in product labeling.
All patients being treated with any type of
antidepressants should be observed closely
for clinical worsening and suicidality
especially during the first few months of
therapy and when the dose is modified.
Pediatrics
FDA has concluded that suicidal thinking or
behavior may increase in pediatric patients
treated with any type of antidepressant,
especially early in treatment. Increases in
suicidal thinking or behavior due to drug can
be expected in about 1 out of 50 treated
pediatric patients. Note that, although
Lexapro is prescribed for pediatric patients,
it is not approved by FDA for use in
pediatric patients.
Adults
Several recent scientific publications report
the possibility of an increased risk for
suicidal behavior in adults who are being
treated with antidepressant medications. Even
before these reports became available, FDA
began a complete review of all available data
to determine whether there is an increased
risk of suicidality (suicidal thinking or
behavior) in adults being treated with any
type of antidepressant medication. It is
expected that this review will require a year
or longer to complete. In the meantime, FDA
is highlighting that adults being treated
with any type of antidepressant medication,
particularly those being treated for
depression, should be watched closely for
worsening of depression and for increased
suicidal thinking or behavior.
This
information reflects FDA’s preliminary
analysis of data concerning this drug. FDA
is considering, but has not reached a final
conclusion about, this information. FDA
intends to update this sheet when additional
information or analyses become available.
Recommendations
All patients being treated with any type of antidepressant for any
indication should be observed closely for clinical worsening,
suicidality, 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. For pediatric patients, such
observation would generally include at least weekly face-to-face
contact with patients or their family members or caregivers during
the first 4 weeks of treatment, then every other week visits for the
next 4 weeks, then at 12 weeks, and as clinically indicated beyond
12 weeks. Additional contact by telephone may be appropriate between
face-to-face visits. Adults whose symptoms worsen while being
treated with antidepressant medications, including an increase in
suicidal thinking or behavior, should be evaluated by their
healthcare professional.
Consideration should be given to changing the therapeutic regimen,
including possibly discontinuing the medication, in patients whose
depression is persistently worse, or who are experiencing emergent
suicidality or symptoms that might be precursors to worsening
depression or suicidality, especially if these symptoms are severe,
abrupt in onset, or were not part of the patient’s presenting
symptoms.
Data Summary
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled
trials of 9 antidepressant drugs (SSRIs and others) in children and
adolescents with MDD, obsessive compulsive disorder (OCD), or other
psychiatric disorders (a total of 24 trials involving over 4400
patients) have revealed a greater risk of adverse events
representing suicidal thinking or behavior (suicidality) during the
first few months of treatment in those receiving antidepressants.
The average risk of such events in patients receiving
antidepressants was 4 percent, twice the placebo risk of 2 percent.
No suicides occurred in these trials; however, the duration of
treatment was limited. Spontaneous post-marketing reports of
suicide-related events associated with the use of SSRIs, including
suicidal ideation, suicide attempt, self-mutilation and completed
suicide have been received. Because these events may also be related
to underlying psychiatric illness, definitive evaluation of the
effects of SSRIs on suicide related events from post-marketing
reports alone is not possible, and the data from controlled clinical
trials is more informative.
Although there are no similar comprehensive data linking the use of
antidepressant medications and an increased risk of suicidality in
adults, FDA has initiated a complete review of all available data.
FDA has asked the manufacturers of all marketed antidepressants to
identify all placebo-controlled clinical trials conducted in adults
in their development programs for their antidepressant products,
regardless of the indication studied, and to provide information
from these trials to FDA. Manufacturers are being asked to use a
similar approach to assembling this information as was used in
evaluating the risk of suicidality in placebo-controlled trials in
pediatric patients treated with antidepressant medications.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.
Other Information
Report Adverse Events to
MedWatch
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Date created: July 19, 2006 |
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