Fwd: [drugawareness] FDA Hearing on Safety of Antidepressants Under 18

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drugawareness

atracyphd2

Tue, 28 Oct 2003 22:20:04 EST

[drugawareness] FDA Hearing on Safety of Antidepressants Under 18

 

 

 

The FDA has scheduled a hearing on Feb. 2, 2004, of the Psychopharmacologic

Drugs Advisory committee and the Pediatric Subcommittee of the Anti-Infective

Drugs Advisory Committee. In order to testify at that hearing on the adverse

effects of antidepressants upon children and teens you must contact Anuja Patel

at 301-827-6790 or e-mail her at patela

 

We encourage as many of you who can come to please do so. At that time the

International Coalition for Drug Awareness intends to hold a seminar for victims

and their families. Additional information will be released as those plans

develop.

 

PLEASE keep in mind that this is for youth only. Considering recent reports

show that the human brain is not fully formed until the early to late 20's I

would think it would be okay to submit reports of those in that age group as

well. The time will come for hearings on other age groups.

 

Also yesterday the U.S. Food and Drug Administration issued a public health

advisory to alert doctors to reports that children and teen-agers with major

depression thought about or attempted suicide while involved in several clinical

trials of the SSRI antidepressants.

 

They state that " . . . 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). "

 

It did warn that no one should stop taking the drugs abruptly, and certainly

not without consulting a doctor - as if there is an army of doctors out there

that evenaware of SSRI withdrawal or how to go about safely withdrawing

patients. (Make sure they get my tape on how to do that when you contact them!)

 

The FDA reviewed reports on eight SSRIs and SNRIs -- Paxil, Prozac, Zoloft,

Celexa, Luvox, Serzone, Effexor and Remeron.

 

Now to see if truth wins out this time rather than the politics of big

business. I say it is long past time to have lives win out over greed! The MCA

in

the UK has set the example of being responsible in this matter since information

came out on this earlier this year. I would hope the FDA follows suit. But so

far I am not impressed with the urgency in their warnings on this very

critical matter.

 

Dr. Ann Blake Tracy,

Executive Director, International Coalition For Drug Awareness

& author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& tape on safe withdrawal " Help! I Can't Get Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

http://www.fda.gov/bbs/topics/answers/2003/ans01256.html

 

 

 

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FDA Talk Paper

 

T03-70

October 27, 2003

 

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

 

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 <A

HREF= " http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01230.html " >Talk Paper</A>

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 <A

HREF= " http://www.fda.gov/cder/drug/advisory/mdd.htm " >

http://www.fda.gov/cder/drug/advisory/mdd.htm</A>.

 

 

 

 

 

 

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