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FDA Public Health Advisory
Suicidality in Adults Being Treated with Antidepressant Medications
Several recent scientific publications suggest the
possibility of an increased risk for suicidal behavior in adults who
are being treated with antidepressant medications. Even before these
reports became available, the 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 antidepressant medications. It is expected that this review
will take a year or longer to complete. In the meantime, FDA is
highlighting that:
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Adults being treated with antidepressant
medications, particularly those being treated for depression, should
be watched closely for worsening of depression and for increased
suicidal thinking or behavior. Close watching may be especially
important early in treatment, or when the dose is changed, either
increased or decreased.
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Adults whose symptoms worsen while being treated
with antidepressant drugs, including an increase in suicidal
thinking or behavior, should be evaluated by their health care
professional.
These recommendations are consistent with existing
warnings for treated adults in the approved labeling (package
insert) for antidepressant medications that can be found at:
http://www.fda.gov/cder/drug/antidepressants/PI_template.pdf The
Healthcare Professional and Patient Information Sheets for the
antidepressant indications will be updated to add this information
within the week. A list of drugs to be included in this update can
be found at:
http://www.fda.gov/cder/drug/antidepressants/antidepressantList.htm
FDA is working closely with the manufacturers of all
marketed antidepressants to fully evaluate the risk of suicidality
in adults treated with these drugs. The FDA has asked these
manufacturers to identify all placebo-controlled 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. The
method used to analyze the data for risk of suicidality in children
using antidepressant medications is described in more detail at the
following web page:
http://www.fda.gov/cder/drug/antidepressants/default.htm. A
similar approach will be used for adults.
FDA’s comprehensive review will involve many hundreds of individual
clinical trials and many thousands of adult patients. It is expected
that this review will require a year or more to complete because of
the large number of trials and the thousands of adverse events that
must be checked for possible evidence of suicidality. The FDA will
make the results of its review available to the public once its
analyses are complete, and will update this advisory in the meantime
if more definitive information becomes available.
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Date created: June 30, 2005 |
