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 fluoxetine is approved for treating
pediatric patients who have depression or
obsessive-compulsive disorder.
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 current analysis
of all available data concerning this drug.
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.