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FDA Talk Paper
T03-70
October 27, 2003 |
Consumer Inquiries: 888-INFO-FDA
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FDA Issues
Public Health Advisory Entitled: Reports Of Suicidality in Pediatric
Patients Being Treated with Antidepressant Medications for Major
Depressive Disorder (MDD)
The Food and Drug Administration (FDA) is issuing a Public Health
Advisory to alert physicians to reports of suicidal thinking (and
suicide attempts) in clinical studies of various antidepressant drugs
in pediatric patients with major depressive disorder (MDD).
FDA recognizes that pediatric MDD is a serious condition for which
there are few established treatment options. In addition to use of
non-medication approaches to treatment, clinicians must often make
choices among drug treatments available for adult MDD. Currently,
Prozac (fluoxetine) is the only drug labeled for use in Pediatric
MDD, and was approved recently under the Pediatric Exclusivity
provision.
FDA has completed a preliminary review of reports for eight
antidepressant drugs –- citalopram, fluoxetine, fluvoxamine,
mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine --
all studied under the pediatric exclusivity provision of the FDA
Modernization Act (FDAMA, 1997). (Although fluvoxamine data were
reviewed along with the other antidepressant drugs, it should be noted
that it is not approved as an antidepressant in the United States.)
FDA notes, to date, that the data do not clearly establish an
association between the use of these drugs and increased suicidal
thoughts or actions by pediatric patients. Nevertheless, it is not
possible at this point to rule out an increased risk of these adverse
events for any of these drugs, including Paxil (paroxetine),
which was the subject of a FDA
Talk Paper on June 19, 2003. That talk paper advised that FDA is
reviewing the safety concerns related to off-label use of Paxil in
children based on recent trials of this drug.
FDA emphasizes that, for the seven drugs evaluated in pediatric
major depressive disorder (MDD), data FDA reviewed were adequate to
establish effectiveness in MDD only for Prozac (fluoxetine). Failure
to show effectiveness in any particular study in pediatric MDD,
however, is not definitive evidence that the drug is not effective
because trials may fail for many reasons.
FDA is aware of press and medical journal reports of suicide
attempts and completed suicides in pediatric patients receiving
antidepressants, and many such reports have also been submitted to FDA
as spontaneous reports. Such reports are very difficult to interpret,
however, in the absence of a control group, as these events also occur
in untreated patients with depression.
FDA emphasized the need for additional data, analyses and a public
discussion of available data. As we recognize that this is a serious
illness, we need a better understanding of how to use the products we
have.
In order to promote a public discussion of data and pertinent
regulatory actions, FDA has scheduled a meeting on February 2, 2004,
before the Psychopharmacologic Drugs Advisory committee and the
Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee.
The agency also reminds physicians and patients that these drugs
must be used with caution, both in adults and children. The labeling
of antidepressant drugs already carries precautionary language that
the possibility of a suicide attempt is inherent in MDD and may
persist until significant remission occurs. Close supervision of
high-risk patients should accompany initial drug therapy.
In its Public Health Advisory, FDA recommends that caretakers of
pediatric patients receiving treatments with any of these
antidepressants talk to their doctors before stopping the use of these
drugs. Patients should not discontinue use of any of these drugs
without first consulting with their physicians, and for certain of
these drugs it is important that they not be abruptly discontinued.
FDA sent the advisory through its Medwatch partners, which includes
doctors and organizations. FDA provides more information on the
clinical study data in its Public Health Advisory, which is available
on the FDA website at
http://www.fda.gov/cder/drug/advisory/mdd.htm.
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