NY Post Exclusive-Paxil Suicide Stunner

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atracyphd2

Wed, 29 Sep 2004 21:08:24 EDT

 

 

NY POST EXCLUSIVE-PAXIL SUICIDE STUNNER

 

 

While we are on the subject of Paxil I am going to send you another

article that I have not had a chance to send sooner. I contains some

startling information on what this company knew and did not want

physicians or patients to know.

 

I quote:

" The New York Post reported Sunday after reviewing data on Paxil

trials that, " The manufacturer of controversial antidepressant Paxil

found in its own trials that children on the drug went though hellish

ordeals of " out of control " behavior, suicide threats, hallucinations

and hospitalization, records show. "

 

It all sounds identical to the early case studies reported on Prozac

that I included in my book with children becoming intensely suicidal

or homicidal leading patients to refer to their trips on Prozac as

" Prozac - Hell and Back " .

Reading these studies is worse than going to a Hollywood horror flick.

Hollywood never quite thought of anything so hellish as the trips

taken on SSRIs.

 

Dr. Tracy

______________

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio

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

Order Number: 800-280-0730

Website: www.drugawareness.org

______________

 

The New York Post reported Sunday after reviewing data on Paxil trials

that, " The manufacturer of controversial antidepressant Paxil found in

its own trials that children on the drug went though hellish ordeals

of " out of control " behavior, suicide threats, hallucinations and

hospitalization, records show. "

 

These reports are among 400 case studies of " adverse events " reviewed

by Dr. Andrew Mosholder, a scientist for the Food and Drug

Administration, which led him to conclude that most antidepressants

raise the risk of suicide in children.

 

This gives the public a glimpse into the contents of the data reviewed

by authorities who are making recommendations for strong warnings on

the use of antidepressants in children.

 

http://www.nypost.com/news/nationalnews/28392.htm

 

 

PAXIL SUICIDE STUNNER

 

 

By SUSAN EDELMAN

 

 

 

 

August 1, 2004 -- EXCLUSIVE

 

The manufacturer of controversial antidepressant Paxil found in its

own trials that children on the drug went though hellish ordeals of

" out of control " behavior, suicide threats, hallucinations and

hospitalization, records show.

 

Those reports, obtained by The Post, are among 400 case studies of

" adverse events " that led a scientist for the Food and Drug

Administration to conclude that most antidepressants raise the risk of

suicide in children.

 

At least 110 American kids have killed themselves while taking

antidepressants during the past decade, new FDA data says.

 

With U.S. doctors continuing to prescribe Paxil and other

antidepressants to millions of kids, the FDA is now considering

whether to issue stronger warnings or advise against their use, as

Great Britain has done.

 

The Post reviewed a sampling of reports of children who suffered

horrific events during Paxil clinical trials from 1994 to 2001. One

internal document lists 23 children and teens as making suicide attempts.

 

The kids swallowed handfuls of pills such as Tylenol,

" self-mutilated, " or did other " self-damaging acts, " it states.

 

 

 

 

Other examples of alarming behavior outlined in the documents include:

 

* A 10-year-old boy taking Paxil for two weeks " became violent and out

of control with aggressive and agitated behavior toward himself. " He

ran away from home and was put on suicide and escape watch in a

children's psychiatric ward;

 

* An 11-year-old girl on Paxil for two weeks was hospitalized after

telling her mom " she wanted to hang herself from the ceiling fan. "

 

* An 11-year-old boy " held a knife to his wrist and threatened to harm

himself " two days after stopping Paxil.

 

* A 14-year-boy on Paxil for two weeks became enraged, punched

pictures, broke glass and suffered deep cuts. After his anger eased,

" He expressed hopelessness and possible suicide thoughts. "

 

In some cases, investigators working for Paxil manufacturer

GlaxoSmithKline said the behavior was " possibly related " to taking

Paxil; in others, they blamed the children's depression, mental

disorder or family problems.

 

In recent weeks, GSK has begun posting on its Web site some previously

unpublished studies after state Attorney General Eliot Spitzer accused

the company of fraud for withholding reports of kids who became

violent or suicidal. But many documents remain privy only to GSK or

under seal in lawsuits, sources said.

 

 

The FDA has now asked a group of Columbia University doctors to review

the reports to determine whether antidepressants may have triggered

the suicide attempts and other dangerous behavior in children.

 

Earlier this year, a scientist in the FDA's own Office of Drug Safety,

Dr. Andrew Mosholder, found that kids on antidepressants became

suicidal twice as often as kids on sugar pills.

 

But FDA brass reacted coolly to his bombshell opinion. The agency

forbade Dr. Mosholder to present his findings at a hearing in February

or to discuss them, officials acknowledged.

 

Mosholder told Senate investigators he was pressured to change his

recommendation, but refused.

 

" We feel that further research is needed before we come to a

conclusion, " FDA spokeswoman Susan Cruzan told The Post. She called

Mosholder's suicide-link " premature. "

 

The FDA has warned doctors to beware of suicidal behavior when

prescribing antidepressants to kids.

 

In defending its pediatric trials, a spokesman for GSK said that " not

a single person " of more than 1,000 patients committed suicide.

 

" Any adverse event is taken seriously by the company, " spokesman Rick

Koenig said Friday.