FDA PUBLIC HEALTH ADVISORY
October 27, 2003
Subject: REPORTS OF SUICIDALITY IN
PEDIATRIC PATIENTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS FOR
MAJOR DEPRESSIVE DISORDER (MDD)
Dear Health Care Professional:
The Food and Drug Administration (FDA) would
like to call your attention to reports of the occurrence of
suicidality (both suicidal ideation and suicide attempts) in
clinical trials for various antidepressant drugs in pediatric
patients with major depressive disorder (MDD). While occurrences of
suicidality are not unexpected in patients with MDD, preliminary
data suggest an excess of such reports for patients assigned to
several of these antidepressant drugs compared to those assigned to
placebo. FDA has completed a preliminary review of such reports for
8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine*,
mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine)
studied under the pediatric exclusivity provision, and has
determined that additional data and analysis, and also a public
discussion of available data, are needed. FDA plans to hold an
advisory committee meeting before the Psychopharmacologic Drugs
Advisory Committee and the Pediatric Subcommittee of the
Anti-Infective Drugs Advisory Committee on February 2, 2004.
You may also be aware of press and medical
journal reports of suicide attempts and completed suicides in
pediatric patients receiving antidepressants. Such reports are very
difficult to interpret, in the absence of a control group, as these
events also occur in untreated patients with depression. Data
available to FDA on these spontaneous reports will also be presented
at the February 2, 2004, advisory committee meeting mentioned above.
Pending the broad public discussion of these
issues, FDA wishes to emphasize several critical points.
In the 20 placebo-controlled trials being
considered for these 8 drugs, involving over 4100 pediatric
patients, there have been no reports of completed suicides.
However, FDA has not at this point been able to rule out an
increased risk of suicidality for any of these drugs, including
Paxil (paroxetine), which was the subject of a FDA Talk Paper on
June 19, 2003.
FDA emphasizes that, for the 7 drugs evaluated
in pediatric major depressive disorder (MDD), data reviewed by FDA
were adequate to establish effectiveness in MDD for only one of
these drugs, Prozac (fluoxetine). Failure to show effectiveness in
any particular study in pediatric MDD, however, is not definitive
evidence that the drug is not effective since trials may fail for
many reasons. FDA recognizes that pediatric MDD is a serious
condition for which there are few established treatment options, and
that clinicians often must make choices among treatments available
for adult MDD.
FDA emphasizes that these drugs must be used
with caution. Prescribers are reminded of the following statement
present in all antidepressant labeling:
“Suicide: The possibility of a suicide
attempt is inherent in major depressive disorder and may persist
until significant remission occurs. Close supervision of high-risk
patients should accompany initial drug therapy. Prescriptions for
Drug X should be written for the smallest quantity of tablets
consistent with good patient management, in order to reduce the risk
of overdose.”
As recommended in the June 19, 2003 Talk Paper
for Paxil, FDA advises that caretakers of pediatric patients
receiving treatment with Paxil, or with any of the antidepressants,
talk to their doctor regarding the use of the drug.
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 (see
labeling for individual drugs).
*Although fluvoxamine data was reviewed with
the other antidepressant drugs data, it should be noted that it is
not approved as an antidepressant in the United States.
Additional Information (FDA
Talk Paper)
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Date created: October 27, 2003 |