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 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
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.
Last Updated on 10/19/03 webmaster@namiscc.org