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 Effexor 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.
FDA has released questions and answers concerning the use of
the antidepressant drug Effexor (venlafaxine) and the class of
antidepressant drugs known as selective serotonin reuptake
inhibitors, or SSRIs in adults.