To: drugawareness@yahoogroups.com
Subject: [drugawareness] UK AND IRELAND’S BAN OF PAXIL IN UNDER 18’s CAUSES FDA TO REVIEW DRUG
From: "Mark Miller" <mmiller18@kc.rr.com>
Date: Fri, 20 Jun 2003 03:14:05 -0000

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The following is the press release from the ICFDA 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
Website: http://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 Director 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
f****ven 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: ****s, 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

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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