Fwd: [drugawareness] FDA WARNS SAY NO TO PAXIL FOR THOSE UNDER 18

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Thu, 19 Jun 2003 15:26:49 EDT

[drugawareness] FDA WARNS " SAY NO TO PAXIL " FOR THOSE UNDER 18

 

 

 

 

The following is the press release from me on this issue that has just been

sent out nationwide and following is the latest news from the FDA confirming

the warning in the US.

 

 

FOR IMMEDIATE RELEASE:

 

UK AND IRELAND'S BAN OF PAXIL IN UNDER 18's CAUSES FDA TO REVIEW DRUG WITH

POSSIBLE SIMILAR PAXIL BAN IN US.

 

US SENATE GATHERING CASES OF ANTIDEPRESSANT-INDUCED VIOLENCE AND SUICIDE IN

US YOUTH

______________________

 

For further information and interviews, contact:-

 

Dr. Ann Blake Tracy,

Executive Director, International Coalition For Drug Awareness

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

 

Office: 801-282-5282

Cell: 801-209-1800

Website: www.drugawareness.org

____________________________

 

Last week, the UK and Ireland's Regulatory bodies banned Paxil for use in

under 18s. Warning letters were sent to all physicians advising Paxil should

not

be prescribed to children because of its potential for violence, suicide,

self harm and medical damage. They also warned of the drug's serious addictive

potential and withdrawal problems.

 

Our FDA is now evaluating the same NINE studies highlighted following the UK

review. Last Friday Senator Charles Schumer (Democrat-NY) asked our FDA to

expedite their investigation and ban Paxil in America to protect children from

additional damage. A US Senate subcommittee is now gathering cases involving

adolescents and children who committed violent acts, suicide, self mutilation

while on this group of medications.

 

The studies came to light TWELVE years after the first study was completed.

Manufacturer, GlaxoSmithKline, may face criminal charges for withholding the

results of these studies.

 

UK authorities are still evaluating SSRI antidepressants for safety in other

age groups, reporting developments as information is gathered.

 

After working on court cases involving these drugs for a decade and a half, I

have a wealth of information from many high profile cases reported in the

news where connection to the drugs was not disclosed. I firmly believe it is in

the public interest to disclose data from these cases. Families filing

wrongful death lawsuits generally have gag orders placed on them after a

settlement,

but I do not and am therefore free to speak. It is clear this code of silence

caused many additional deaths that should never have happened.

 

I can discuss a large number of tragic cases involving Paxil, violence and

children including:-

 

The Carr Children (10 & 15) killed their 6 year old brother in Dallas last

summer and buried him out back (both were on Paxil).

 

Elizabeth Bush (14) shot her classmate at her Catholic school in PA two years

ago while under the influence of Paxil.

 

Jarred Viktor (15), a CA boy who had never been in a fight before, stabbed

his grandmother 61 times after only five days on Paxil.

 

In 1997 NJ Nick Mansies (15) invited a young boy (6) into his home while he

was selling cookies door to door. Under the influence of Paxil, Nick sodomized

and beat the boy to death. Two months ago a 10 year old boy in NJ while on one

of these antidepressants killed a 3 year old boy in the same way. The pattern

forming is that as the number of young children prescribed these drugs

increases, more young children are committing violent crimes.

 

A 15 year old boy in TN shot and killed his father after 10 days on Paxil,

then attacked his mother with a shovel

 

Chris Shannahan (15) from Rigby, ID killed a woman in a convenience store

after three months on Paxil.

 

A 12 year old boy in Chester, SC shot his grandparents while they slept, then

set the house on fire.

 

During the past 14 years, I have supported thousands suffering serious

adverse reactions and withdrawal effects as a result of prescribed mind altering

drugs. My book, " Prozac: Panacea or Pandora? - Our Serotonin Nightmare, " is

about

SSRI antidepressants, the most potent of which is Paxil. As the Executive of an independent, nonprofit educational organisation focusing on

dangerous prescription medications, I have lectured about the many varied

physical

and psychiatric antidepressant adverse reactions for numerous years now -

exactly the same dangers now confirmed by regulatory agencies in the UK and

Ireland.

 

I have been consulting in the Columbine tragedy and work closely with Mark

Taylor, the first boy shot that day. He took 7 - 13 bullets in the chest that

day collapsing both lungs. Known as the " Columbine Wonder Boy " for surviving

those deadly wounds, he would be happy to be interviewed if it would save others

from experiencing similar trauma to what he endured.

 

I can also arrange for you to interview Corey Baadsgard as well. Mark and

Corey have become good friends and together, are educating others about the

dangers of these drugs. At first glance these two seem to be an odd couple

because

Corey almost committed a Columbine at his own school in a small farming

community in eastern Washington State while under the influence of these drugs.

They both know firsthand why school shooting happen. Mark has forgiven Eric

Harris for shooting him and knows that Eric and Corey never would have been

involved in a school shooting if it were not for these antidepressants.

 

I was also the expert in the Phil Hartman murder/suicide, working closely

with the family who are in full agreement with me discussing details of that

case

whenever I can to raise awareness of these antidepressant dangers. That case

was settled by Pfizer, the makers of Zoloft, several years ago.

 

I have also consulted on numerous high profile cases relating to mothers who

have killed their children, including the Andrea Yates case; the Atlanta Day

Trader shooting; the NY City subway bombing; the Connecticut Lottery Shooting;

the Edgewater Technologies shooting near Boston; the decorated NJ police

officer; Edward Lutz, who shot five of his neighbors and attempted to kill his

best friend, a police chief, before killing himself last year, amongst many

others.

 

America's children are in danger and need protecting. Much information

surrounding the dangers of these drugs has been withheld and in light of recent

evidence, parents are likely to be worrying and need to know how their children

can safely withdraw from these drugs.

 

-Ends-

 

" New data from various clinical trials showed episodes of self-harm and

potentially suicidal behavior were between 1.5 and 3.2 times higher in patients

under 18 taking the drug than in those receiving a placebo. "

 

http://www.chron.com/cs/CDA/ssistory.mpl/business/1959728

 

 

June 19, 2003, 1:38PM

 

FDA: Teens, children shouldn't use Paxil

 

Reuters News Service

 

NEW YORK - The U.S. Food and Drug Administration today warned that patients

under age 18 should not take GlaxoSmithKline's antidepressant Paxil because of

a possible increased risk of suicidal impulses associated with the drug.

 

The statement from the FDA comes nine days after British regulators issued

similar precautions for children and adolescents. The drug, one of Glaxo's top

sellers, is known as Seroxat in the UK.

 

The drug generated global sales of about $3.4 billion last year, but it is

facing the prospect of generic competition in the United States within the next

18 months.

 

The medicine has been the subject of increased public concern because of

reports of adverse reactions, prompting Britain to set up an expert panel to

investigate.

 

Although only officially approved for adults, doctors have had discretion to

prescribe Paxil/Seroxat to young people on a so-called " off-label " basis.

 

Although companies are allowed to promote and market drugs only for approved

uses, doctors are free to prescribe drugs to patients at their discretion.

 

Children account for a small portion of patients taking the antidepressant.

For instance, a total of 4 million prescriptions were written for Seroxat in

Britain last year, with around 8,000 patients under 18 receiving treatment.

 

New data from various clinical trials showed episodes of self-harm and

potentially suicidal behavior were between 1.5 and 3.2 times higher in patients

under 18 taking the drug than in those receiving a placebo.

 

 

 

 

 

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