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atracyphd2

Mon, 22 Mar 2004 01:40:10 EST

[drugawareness] Antidepressant-Induced Violence in Youths Causes FDA to

Examine Link

 

 

As you have noticed on our site, the number of news articles coming out since

the FDA hearing have increased tremendously! Updating you on all of them is

impossible. But I will try to update you on the most important or Mark will

post them on the front page of the site with all the latest news.

 

We also encourage you to search Google News for new articles we may miss.

 

Today the LA TIMES ran a large article discussing the violence associated

with the SSRIs. Note this statement from the article:

 

" And GlaxoSmithKline, during clinical tests on children with

obsessive-compulsive disorder or depression, found that the percentage of

children

taking Paxil who became hostile — which was defined as everything from

angry thoughts to violent acts — ranged from 6.3% to 9.2%. For those taking

the placebo, the range was zero to 1%, according to published records. "

 

This is critical information that needs to get out. Once again I would

encourage you to get this information to your local papers, BUT once again I

stress

the urgency of including what this article left out:

 

#1 The warning that abrupt or rapid withdrawal (which most doctors

continue to do) is VERY dangerous and can lead to even more serious problems as

the patient can experience seizures, heart attack, suicidal or homicidal

ideation along with psychosis, severe flu-like symptoms, electric shocks, etc.

from

coming down too rapidly. It is not worth taking the chance.

 

#2 Too many patients on these drugs will sit back and say, " Oh, those

people were that way before the drug. The drug had nothing to do with their

behavior and I am not that kind of person. "

 

But they need to understand that this is a drug reaction the patient has no

control over. As I explain in detail in my book about SSRIs, Prozac: Panacea or

Pandora? - Our Serotonin Nightmare, when one reaches a point where the REM

sleep has been repressed for long enough the body and brain WILL force one into

REM while awake to compensate.

 

Add to that this: The impairment produced by the drugs of one's ability to

metabolize serotonin produces nightmares. Then you, in that REM state - the

dream state, begin act out that nightmare.

 

The only control one has over this type of response is whether or not he

chooses to take the drug that produces the nightmares and represses REM leading

to

this end result.

 

We now know that 80% of the cases being diagnosed with this disorder (RBD)

are on SSRIs. Another 6% are on the older antidepressants.

 

#3 Before these drugs hit the market this sleepwalk nightmare known

as RBD was known as a " drug withdrawal state. " This will give you some idea of

why it is so important to avoid serious withdrawal from an SSRI

antidepressant. I cannot tell you how often I hear from people that they have

tried and

tried to come off these drugs before, but after getting my tape on withdrawal

they

were FINALLY able to come off without serious problems and make it off and

get well.

 

If 80% of the patients being diagnosed with this horrible sleepwalk state in

which the large majority hurt themselves or someone else, how many more will

experience RBD in withdrawal from SSRIs? It is clear to me that we can expect a

high rate.

 

PLEASE, PLEASE, PLEASE, with all of this information coming out about the

dangers of SSRIs, get this warning to people everywhere about the dangerous

withdrawal! We have far too many horrible cases coming in already without having

the numbers absolutely skyrocket due to the lack of warning about withdrawal -

especially with children.

 

Ann Blake Tracy, PhD

 

Executive Director, International Coalition For Drug Awareness

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

& audio tape or CD on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

 

 

http://www.latimes.com/news/nationworld/nation/la-na-violent21mar21,1,3763470.

story?coll=la-headlines-nation

 

March 21, 2004

 

 

THE NATION

 

FDA Probes Downsides of Antidepressants

 

Cases of youths turning violent while taking the drugs lead panel to examine

possible links to adverse behavior, especially in minors.

 

By Elizabeth Shogren, Times Staff Writer

 

WASHINGTON — A popular honors student who played on his varsity high school

basketball and baseball teams in rural Washington state, Corey Baadsgaard

nevertheless would come home complaining that no one liked him.

 

His family physician prescribed Paxil, a popular antidepressant. But

Baadsgaard, then 16, sunk deeper into depression. The doctor switched him to a

different antidepressant, Effexor, and stepped up the dose over a three-week

period

from 40 milligrams to 300. The first morning Baadsgaard took 300 milligrams, he

felt rotten and went back to bed.

Â

Three years later, he said, he still has no memory of what happened next: no

memory of taking a high-powered rifle into his third-period English class, of

herding his classmates and teacher into a corner, of holding them at gunpoint

for 45 minutes, of being persuaded by the principal into giving up his gun.

 

He spent 14 months in a juvenile detention center.

 

Baadsgaard and his father believe the antidepressants made him suicidal at

first, then violent. The Food and Drug Administration — based on such

anecdotal

evidence and the results of clinical trials — is reconsidering its decision

not to require that doctors and parents be warned about possible side effects of

the drugs known as serotonin reuptake inhibitors.

 

The link to suicide was the focus of an FDA advisory committee meeting last

month. But testimony from Baadsgaard and others who had turned violent while

taking the drugs suggested to several members of the committee that the FDA

should look more broadly at the medications' adverse effects.

 

Dr. Joseph Glenmullen, a Harvard Medical School psychiatrist who has studied

serotonin reuptake inhibitors, said Baadsgaard's story was plausible. And he

wondered whether antidepressants could help explain the rash of school

shootings and murder-suicides over the last decade.

 

People who take antidepressants, Glenmullen said, can " become very distraught…

.. They feel like jumping out of their skin. The irritability and impulsivity

can make people suicidal or homicidal. "

 

Added Dr. David Healy, director of the North Wales Department of

Psychological Medicine: " What is very, very clear is that people do become

hostile on the

drugs. "

 

Glenmullen and Healy emphasized that parents, patients and doctors should be

warned to watch for potentially dangerous reactions. However, both said they

planned to continue prescribing the drugs to their patients.

 

The pharmaceutical companies and many doctors dispute the suggestion that

antidepressants play a role in violent or suicidal acts.

 

Dr. Alastair Benbow, the European medical director for GlaxoSmithKline,

Paxil's manufacturer, refused to comment on specific cases. But he said he

didn't

believe there was " any clear evidence that Paxil is linked with suicide,

violence or aggression — and certainly not homicide. "

 

The source of aggressive behavior, doctors and mental health groups said, may

lie with the illness and not the treatment. And failing to treat depression,

they explained, could have consequences as grave as treating it.

 

" Suicide and violence are well-recognized outcomes of depression itself, "

Benbow said.

 

Although only one antidepressant, Prozac, is explicitly approved by the FDA

for children, doctors routinely prescribe others to their young patients. The

National Mental Health Assn. estimates that depression affects 1 in 33 children

and 1 in 8 adolescents; Healy believes young people account for 1 million of

the 20 million Americans who take antidepressants annually.

 

Most of the drugs carry no specific warnings about increasing the risk of

suicide or violence.

 

But one company, Madison, N.J.-based Wyeth, warned doctors in a letter last

summer that children taking Effexor in clinical trials had shown increased

hostility and suicidal tendencies compared with children taking placebos. The

company directed doctors not to prescribe Effexor to children.

 

And GlaxoSmithKline, during clinical tests on children with

obsessive-compulsive disorder or depression, found that the percentage of

children taking Paxil

who became hostile — which was defined as everything from angry thoughts to

violent acts — ranged from 6.3% to 9.2%. For those taking the placebo, the

range was zero to 1%, according to published records.

 

Benbow said the trials provided evidence of increased hostility in children,

particularly among those younger than 12 and with obsessive-compulsive

disorder.

 

But Dr. Timothy Wilens, a pediatric pharmacologist at Massachusetts General

Hospital in Boston, said that when he and his colleagues treated 82 children

with antidepressants for a variety of psychiatric problems, " there were no

serious outcomes " like suicide or homicide. Although a quarter of the patients

had

adverse responses like agitation, aggression, increased depression or

irritability, Wilens said he didn't " know of any evidence that these medicines

turn

people into predators. "

 

The link between antidepressant reuptake inhibitors and violence came under

scrutiny 10 years ago in a trial stemming from the case of Joseph Westbecker,

who weeks after starting Prozac killed himself and eight others at a

Louisville, Ky., printing plant.

 

Twenty-seven survivors and relatives of the dead sued Eli Lilly, Prozac's

manufacturer. The jury ruled in the company's favor after the plaintiffs'

lawyers

rested their case without presenting key evidence.

 

The judge suspected a behind-the-scenes deal between the drug company and the

plaintiffs. An investigation showed that Lilly had given huge settlements to

all the attack survivors and their lawyers.

 

In 1997, the judge changed the official record from a jury verdict in Lilly's

favor to dismissal of a settled case. But the drug company had won the case

in the eyes of public opinion.

 

" It's an example par excellence of the behind-the-scenes maneuvering that the

companies have done repeatedly to obscure the side effects from public view, "

Glenmullen said.

 

Drug companies have not always won.

 

A federal jury in Wyoming in 2001 found against SmithKlineBeecham (now

GlaxoSmithKline) in the case of Donald Schell, 60, who had been taking Paxil for

two

days when he killed his wife, daughter, granddaughter and himself. The jury

found that Paxil could cause some people to become homicidal or suicidal, and

that the drug was a " substantial " factor in the Schell murder-suicide. The

company was ordered to pay relatives of the victims $6.4 million.

 

But most of the hundreds of cases against the makers of antidepressants have

been dropped, dismissed or settled out of court. Only three have made it to

trial, said Andy Vickery, a lawyer in the Schell case.

 

Vickery now represents defendants who have committed horrible acts while

taking antidepressants. He recently decided to take on the case of Christopher

Pittman, a youth who in 2001 killed his paternal grandparents and set their

South

Carolina house on fire. His trial is to begin in April.

 

At the FDA hearing, Pittman's father read a letter written by his son while

he was in detention, about how while taking Zoloft he " took the lives of two

people that [he] loved more than anything. "

 

While on the drug, Pittman wrote, he " hated the whole world for no apparent

reason. " He got into fights and blew up at the smallest things. Things kept

getting worse, he wrote.

 

" When I was lying in my bed that night, I couldn't sleep because my voice in

my head kept echoing through my mind — telling me to kill them — until I got

up, got the gun, and I went upstairs and I pulled the trigger, " wrote Pittman,

who is now 14.

 

In Baadsgaard's case, the violent outburst was completely out of character,

said his father, Jay Baadsgaard. Corey never got into fights, his father said.

In their family, he was the " hugger. "

 

So, " as soon as it happened, we knew the drugs had to have something to do

with it, " Jay Baadsgaard said. Corey stopped taking the drugs while in juvenile

detention and has not had any behavioral problems since, his father said.

 

Jay Baadsgaard remains angry at the drug companies, and said the drugs should

be banned for children. " These drugs are hell, " he told the FDA panel in

February.

 

Corey Baadsgaard didn't go that far. He said he believed depressed kids

should try counseling, and the drugs should be prescribed only as " the last

resort. "

 

 

 

 

 

 

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