FDA Issues Public Health Advisory

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http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01256.html

 

FDA Talk Paper

T03-70

October 27, 2003

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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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