Fluvoxamine
Maleate 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 fluvoxamine is approved
for treating pediatric patients only if they have
obsessive-compulsive disorder (OCD).
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 |