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Alert for Healthcare
Professionals
Bupropion hydrochloride
(marketed as the antidepressant Wellbutrin)
FDA Alert [7/2005]: Suicidality in Pediatric and Adult Patients
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 bupropion 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.
To
report any unexpected adverse or serious events associated with the
use of bupropion, please contact the FDA MedWatch program at
1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
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.
Additional Information
http://www.fda.gov/cder/drug/antidepressants/default.htm
FDA Patient
Information Sheet
http://www.fda.gov/cder/drug/infosheets/patient/bupropionPT.htm
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Bupropion
Date created: May 2005, updated May 9, 2007 |
