3/15/2002 • Rare Neurologic Syndrome Linked to Antidepressant

3/15/2002 • Rare Neurologic Syndrome Linked to Antidepressant

Jim Rosack

Psychiatric News March 15, 2002 Volume 37 Number 6, p. 31

Neurologists warn other clinicians that SSRIs could contribute to a potential increase in certain patients‚ risk of having a rare form of stroke.
Rare Neurologic Syndrome Linked to Antidepressant

http://www.neurology.org/cgi/content/abstract/58/1/130

Jim Rosack

Psychiatric News March 15, 2002 Volume 37 Number 6, p. 31

Neurologists warn other clinicians that SSRIs could contribute to a potential increase in certain patients‚ risk of having a rare form of stroke.

A new report from a group of neurologists warns that combinations of medications that modulate brain levels of serotonin, including SSRIs and other antidepressants, could lead to a relatively rare form of stroke due to marked vasoconstriction.

The report, which appeared in the January issue of Neurology, includes case studies of three patients who developed Call-Fleming syndrome, which is characterized by sudden-onset severe headache, focal neurological deficits, and seizures. Although rare, the syndrome is most commonly seen in women.

The first patient studied, a 46-year-old woman, developed a “worst ever” headache, nausea, and blurred vision, which were followed a few days later by escalating neurological symptoms. The woman‚s medications included sertraline and trazadone, and for two days prior to developing symptoms, she had taken an over-the-counter cold remedy that contained dextromethorphan. Diagnostic testing confirmed severe, diffuse, intracranial vasoconstriction, including a 70 percent constriction of the origin of the vertebral artery.

In addition, several areas of ischemic stroke were identified. Within a week of discontinuing both the sertraline and the cold remedy, the women was discharged in markedly improved condition.

The second case described a 45-year-old woman who developed a sudden, “explosive” headache, again with accompanying nausea. Four weeks earlier, she had been started on paroxetine 40 mg and clonazepam 0.25 mg for a recurrence of major depression. Shortly before the onset of the headache, she had taken a cold remedy with dextromethorphan and pseudoephedrine. Again, severe, bilateral vasoconstriction was demonstrated on cerebral angiography, and MRI demonstrated multiple areas of ischemic stroke. The patient‚s paroxetine was discontinued, and her symptoms subsided. Interestingly, four months later, this patient again had a worsening of her depression and was prescribed mirtazapine. Within two weeks she again developed headaches, which resolved when the mirtazapine was stopped.

The third patient was a 34-year-old male who developed an “explosive” headache with sensitivity to light, nausea, and extreme fatigue. His family history included migraine syndrome, and as a result, he was treated with sumatriptan, a common migraine medication known to be a serotonin receptor agonist that causes significant cerebral vasoconstriction. Following a second dose of that drug later the same day, the patient had a generalized seizure, and an MRI five days later showed multiple bilateral ischemic areas.

Although the patient denied any use of illicit drugs, recent cocaine use was suspected.

Aneesh Singhal, M.D., the primary author of the report, has seen about a dozen similar cases in his practice. Although he believes that Call-Fleming syndrome is rare, he told Psychiatric News that it includes a number of conditions that are often labeled in different ways, and thus the syndrome may be underrecognized.

“This is a preliminary observation; it needs confirmation,” he stressed. “It ‚s important to note that it is not the individual drugs, that by themselves might enhance the risk [of stroke from vasoconstriction], but rather the combination of drugs,” he told Psychiatric News.

“It is conceivable that someone who has a migraine syndrome, is trying to lose weight, and is depressed, which is not an uncommon situation, may take three or four agents, and thus have increased risk of vasoconstriction and end up with stroke.”

Singhal said that differential diagnosis needs to include the possibility of serotonin-induced vasoconstriction in any patient who has a sudden onset of severe headaches that are not explained by any of the accepted causes, most commonly a subarachnoid hemorrhage. “If the known causes are ruled out, you have to remember that there is one more cause, and that is vasoconstriction.”

Singhal said patients who are taking serotonin-modulating medications should be routinely asked about the presence of moderate to severe, persistent or recurrent headaches. He stressed that although headache is a common side effect of many of these medications, when the headache is recurrent or sustained and moderate or severe, medications should be at least temporarily suspended, and the cause of the headache investigated.

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2/28/2002 • Antidepressant drug trials turn away most of the depressed population

2/28/2002 • Antidepressant drug trials turn away most of the depressed population

Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital

Brown University

While antidepressants are among the most frequently prescribed medications, most patients treated for major depression in a typical outpatient psychiatric practice would not qualify to take part in a clinical trial for a new antidepressant drug, according to a new Brown University study.

Antidepressant drug trials turn away most of the depressed population

http://www.brown.edu/Administration/News_Bureau/2001-02/01-091.html

Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital

Brown University

While antidepressants are among the most frequently prescribed medications, most patients treated for major depression in a typical outpatient psychiatric practice would not qualify to take part in a clinical trial for a new antidepressant drug, according to a new Brown University study.

Trials to determine the effectiveness of antidepressants have historically evaluated only a small subset of depressed individuals with a very specific clinical profile. People diagnosed with other psychiatric problems and people with mild depression are among those excluded, says the study, which appears in the March 2002 American Journal of Psychiatry.

“When you take any medicine you assume it‚s been found to be effective for your condition,” said Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital, and the study‚s lead researcher. “No one knows for sure whether antidepressants are effective for most of the patients we treat.”

As few as 15 percent of 346 depressed patients evaluated in the Rhode Island Hospital Department of Psychiatry outpatient clinic would have met the eligibility requirements of a standard drug trial, depending on the criteria.

To determine whether the clinic patients would qualify for the drug studies, the researchers reviewed inclusion and exclusion criteria used in 31 antidepressant trials published from 1994 to 1998 in five leading psychiatric journals. Many of the studies excluded patients who had psychotic features, a history of manic episodes, suicide risk, unstable medical illnesses, or a history of drug or alcohol abuse. Several also excluded subjects with eating disorders, obsessive-compulsive disorder or panic disorder.

Nearly all of the studies excluded patients who fell below a cutoff score on a measure of symptom severity, even though they were diagnosed with major depression. “We are not aware of any other medical condition in which individuals with the disorder are routinely excluded because they are not sick enough,” said Zimmerman.

“Drug companies are concerned that individuals with mild depression will respond just as well to a placebo as they will to antidepressant medication,” said Zimmerman. “However, this represents a sizable number of individuals who are prescribed these medicines, especially by primary care physicians.”

The researchers conducted diagnostic evaluations of patients at the Rhode Island Hospital Department of Psychiatry outpatient practice, a group ranging in age from 16 to 65. Excluding patients with any of the features commonly used in efficacy trials eliminated two-thirds of the patients. If patients with an anxiety disorder were also excluded, then more than 85 percent of the patients would not have qualified for a drug study of antidepressants ˆ yet more than 90 percent of the patients in the study for whom prescribing information was available were being treated with antidepressants at the time of the evaluation.

Some extrapolation of antidepressant studies by clinicians will always be necessary, Zimmerman said. It would be impossible to establish the effectiveness of antidepressant medications in every conceivable population of depressed patients. But the current practice of limiting studies to only “pure” moderate-to-severely ill depressives may skew the findings of drug trials, he added. If antidepressants are, in fact, not effective for some of these large subgroups of depressed individuals, their prescription incurs an unjustifiable exposure of risks and side effects, and alternative treatments need to be considered.

Opening antidepressant trials to patients with a wider range of symptoms would allow researchers to learn whether any specific subsets respond or do not respond to a drug. The question now is whether government mandates are necessary to make trials more inclusive, Zimmerman said. There is little motivation for drug companies ˆ whose primary aim is to show that their medication is safe and that it works for some patients ˆ to do this.

“Drug companies have been correct in assuming that if they show their medicine works for a highly select group of depressed patients, physicians will use it for all patients,” said Zimmerman.

This study was supported by grants from the National Institutes of Mental Health. Zimmerman worked with Jill I. Mattia, clinical assistant professor, and Michael A. Posternak, research fellow, in the Department of Psychiatry and Human Behavior at Brown University.

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Effexor gave me the urge to take my life.

“Anybody who says Effexor is not dangerous is lying”

 

I am 36 years old with 2 children. Last year was a traumatic year, splitting up with my children’s father, losing a baby, working 46 hours per week and starting another relationship with mentally cruel man. In September my doctor put me on Effexor 75mg for depression, which started me on a downward spiral with hideous side effects.

Anybody who says Effexor is not dangerous is lying. After 2 months on the drug, I stuck a hose to my exhaust pipe of my car, took 2 sleeping tablets so I would not wake up and get out, and went to sleep. EIGHT hours later I awoke, and drove home dejected and angry. All of this was on 300mg of Effexor. I plummeted even further, slashing my wrists over 100 times, and never once did I miss a dose.

I was sleeping approx 4 hours per night, put on 10 kilos with no real change in my diet and the brain zaps were very real. I decided to wean myself off the tablets against my doctors advise, and had the worst week of my life. Fast-forward to now 6 weeks later, and I truly believe Effexor gave me the urge to take my life. I feel fantastic, in control and nearly normal. I no longer plot my death or have the urge to cut. The only thing I can thank Effexor for is sorting out my true friends in this world. My suicide attempts were very serious ones, not telling anybody beforehand and by all accounts I should be dead. If it were not for unleaded petrol, I would be. The difference is, it would not be from suicide, it would have been from Effexor.

 

2/9/2002

This is Survivor Story number 43.
Total number of stories in current database is 48

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Suit: Antidepressant is Addictive

A lawsuit contends the manufacturer of the popular anti-depressant Paxil concealed evidence that the drug can be addictive

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

8/25/2001

Suit: Antidepressant is Addictive

http://dailynews.yahoo.com/htx/ap/20010825/us/paxil_suit_1.html

To learn more, go to http://www.baumhedlundlaw.com

A lawsuit contends the manufacturer of the popular anti-depressant Paxil concealed evidence that the drug can be addictive.

The lawsuit was filed Friday on behalf of 35 people from around the country who say they suffered symptoms ranging from electric-like shocks to suicidal thoughts after discontinuing use of the drug.

The lawsuit, which seeks class-action status and unspecified damages, says GlaxoSmithkline PLC concealed the possibility of physical and psychological withdrawal symptoms from the drug. It alleges fraud, deceit, negligence, liability, and breach of warranty.

There was no immediate comment from the British-based company. Calls to its U.S. offices after business hours Friday were not returned.

Introduced on the U.S. market in 1992, Paxil is the country’s second-largest selling anti-depressant.

Paul Domb, 42, of Miami, said that after he stopped taking Paxil last year, he suffered from convulsions, night sweats, and suicidal thoughts for about six weeks.

He said he thought the problems had to do with recent heart surgery, but after researching his symptoms he concluded they were caused by his withdrawal from Paxil.

“I stopped taking this drug … and it destroyed me. It almost killed me,” he said.

In June, a Wyoming jury awarded $8 million in damages to the family of a man after determining that Paxil caused him to kill his wife, daughter and granddaughter before committing suicide.

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4/23/2001 – Matt Miller's Zoloft tragedy featured in UK article

When Depression Turns Deadly:
Can Antidepressants Transform Despair into Suicide?

ANNE McILROY
THE GLOBE AND MAIL
Saturday, April 21, 2001

www.globeandmail.com

When Matt Miller’s family moved to a bigger house in a new neighbourhood in
Kansas City, Mo., the athletic 13-year-old with thick blond hair found that
he couldn’t penetrate the cliques at his new school. He was a nobody, an
outsider.

“He was angry at us, he was angry at the school, his grades suffered. He
wasn’t himself,” said his father, Mark Miller.

The boy’s teachers recommended that he see a psychiatrist, who prescribed
Zoloft, an antidepressant in the same chemical family as Prozac.
The doctor said it would help Matt’s mood, make him feel better about
himself. The boy started taking the pills and seemed to be in good spirits
for a few days.

But then he began showing signs of intense nervousness and agitation. He
couldn’t sit still, his father remembers. He kept kicking people under the
table. His eyes were sunken and he couldn’t sleep, yet he had a restless
energy.

After six days on the drug, on July 28, 1997, Matt hanged himself in his
bedroom closet.

“Suicide always takes you by surprise, but no one could have imagined that
Matt would have done that,” Miller said in an interview. “There was no
previous attempt, no serious threat of it, no note, no premeditation.
“It was a very impulsive act I am convinced was brought about by the
stimulant nature of the drug.”

Miller has launched a lawsuit against Pfizer Inc., which makes Zoloft. He is
one of about 200 people who have sued — so far unsuccessfully — the makers
of Prozac and similar products. The plaintiffs contend that the drugs, known
as selective serotonin reuptake inhibitors, caused their loved ones to kill
themselves and, in some cases, hurt or kill others as well.
One of the few cases to go to trial so far was that of William Forsyth, a
63-year-old wealthy Hawaii businessman who stabbed to death his wife of 37
years and then killed himself in 1993. At the time, he had been taking
Prozac for 11 days for panic attacks.

In 1999, a jury in the civil lawsuit cleared Prozac of liability in the
deaths. Forsyth’s adult children began another suit last year accusing Eli
Lilly and Co., the maker of the drug, of covering up damaging details about
the antidepressant.

Chief among the scientific experts who have given people, including Miller
and Forsyth’s children, reason to believe that a link may exist between
antidepressants and suicide is Dr. David Healy, whom Miller has engaged as
an expert witness in his suit.

Healy is a well-known British psychiatrist who argues that Prozac and
similar drugs may trigger suicide in some patients, and that there should be
warning labels on the products.

To Miller, Healy is a hero, a crusading scientist with the guts and
credibility to challenge the powerful, multinational drug companies in an
era in which many researchers and institutions depend on them for funding.
But discussing the down side of Prozac does not appear to have been a good
career move. Healy’s blunt expression of his views may have cost him a job
at the Centre for Addiction and Mental Health, a teaching hospital
associated with the University of Toronto. The centre had been recruiting
him for months, but last year rescinded his written job offer after he gave
a speech warning that Prozac may trigger suicide in some patients.

Eli Lilly Canada Inc. is a major corporate donor to the centre, but
university and hospital officials say their decision had nothing to do with
wanting to please the drug company or to avoid damaging future fundraising
efforts. They say their reasons are confidential.
Healy says the only explanation he was offered was that his lecture
“solidified” the view that he was not a good fit.

For Eli Lilly’s part, it points out that a U.S. Food and Drug Administration
panel of experts voted six to three against requiring Prozac to carry a
suicide-risk warning label. In September of 1991, the FDA concluded that
there was no credible evidence of a causal link between the use of
antidepressant drugs, including Prozac, and suicides or violent behaviour.
And a paper published in March of 1991 by Jerrold Rosenbaum of Massachusetts
General Hospital found that patients on Prozac were not prone to suicide any
more than patients on other medication.

Eli Lilly said, in a written response to questions from The Globe and Mail:
“There is, to the contrary, published scientific evidence showing that
Prozac and medicines like it actually protect against such behaviour —
reducing aggressive and suicidal thoughts and behaviour.”

When Prozac was introduced in the late 1980s, it was billed as a wonder drug
that could combat depression with far fewer risks than previous medications,
including the danger of an overdose or problems when mixed with alcohol.
Prozac and drugs like it — Zoloft, Paxil and Luvox — were said to help
with emotional limitations such as low self-esteem and fear of rejection.
Prozac was a commercial as well as a medical miracle, sold to an estimated
40 million people worldwide since it hit the market.

The drug boosts levels of the neurotransmitter serotonin, which seems to
improve the mood of patients. But within a few years of Prozac’s launch came
hints that it brought out a dark side in a small fraction of users.
Martin Teicher, a researcher at Harvard University, published an article in
the American Journal of Psychiatry in 1990 that discussed six cases in which
patients became intensely preoccupied with suicide after taking the drug.
Other scientists also found a potential link between Prozac and suicide.

Healy says in one of his published papers that Eli Lilly scientists
collaborated with the FDA on designing an experiment that would measure how
serious the problem was, but they then decided against conducting it.
Instead, in 1991, Eli Lilly published an analysis of data taken from
existing trials. Its conclusion? There was no increase of suicidal thoughts
or suicide among depressed patients taking Prozac.

But Healy says in the paper that data from only about one-eighth of the
patients in the clinical trials were included. No mention was made that some
had been prescribed a sedative that may have alleviated an intense nervous
state that can lead to suicide, which is called akathisia, he says.
The analysis also did not point out that 5 per cent of patients dropped out
of the studies because they were anxious and agitated and may have been
suffering from akathisia, Healy says.

Another document, dated Nov. 13, 1990, shows that company scientists were
pressured by executives to soften physicians’ reports of suicidal thoughts
or suicide attempts, according to Harvard psychiatrist Joseph Glenmullen,
who obtained the document and is author of the book Prozac Backlash.
Additional evidence about the potential risks can be found in the patent for
a second-generation Prozac pill, which Eli Lilly has licensed. The patent
says the new and improved Prozac would decrease side effects including:
“nervousness, anxiety, and insomnia,” as well as “inner restlessness
(akathisia), suicidal thoughts and self-mutilation.”

But at the same time, Eli Lilly says these symptoms are not associated in
any significant way with taking the current version of Prozac.
The new Prozac — which incidentally was co-developed by Teicher, one of the
drug’s early critics — isn’t yet on the market, Last year, Healy published a
study in the journal Primary Care Psychiatry that said two of 20 healthy
volunteers taking an antidepressant in the same family as Prozac reported
feeling suicidal.

But by his calculations, probably 40,000 people have committed suicide while
on Prozac since its launch, above and beyond the number who would have taken
their own lives if their condition had been left untreated.

The German government now requires warning labels, and Britain is
considering them. Canada and the United States do not.
Healy says he is not opposed to Prozac and thinks that it can do a lot of
good. But he says it is unethical and irresponsible not to warn doctors
about the potential dangers, and believes Eli Lilly chose not to do so to
maximize profits.

He says family doctors seem to be increasingly prescribing Prozac and other
antidepressants to children and now to women complaining of severe
premenstrual symptoms, yet patients in North America do not have to be told
about the potential risks.

Eli Lilly and the other drug companies argue that depression, not
antidepressants, are to blame for suicides. Pfizer is trying to have Healy
barred from testifying in the Miller case, questioning his credibility as an
expert witness.

So what are Canadian consumers to think? Jacques Bradwejn, chairman of the
psychiatry department at the University of Ottawa, says he has reviewed the
literature and agrees with the FDA and Eli Lilly that there is no evidence
that Prozac and similar drugs cause more suicides than would have occurred
if patients had not been treated.

But a small number of patients — even as many as 1 per cent — may fall
into a nervous state that could trigger suicide, he said, adding that more
research is needed to better understand the problem.

While Prozac may be overprescribed for patients who are not truly ill,
Bradwejn worries that the message that the Prozac is dangerous will do more
harm than good for those who are moderately to severely depressed.
“If the message is too alarmist, it could have a very negative effect on
Canadians.”

DEPTHS OF DESPAIR

A study by Dr. David Healy found that two of 20 healthy volunteers taking a
selective serotonin reuptake inhibitor in the same family as Prozac reported
suicidal feelings. This is the story of one of those people, a 30-year-old
woman who didn’t know what drug she was taking, as recorded in the study.
“On the Friday she telephoned early in the morning, distressed and tearful
from the previous night. Her conversation was garbled. She described almost
going out and killing herself. . .

“The night previously she had felt complete blackness all around her. . . .
She felt hopeless and alone. It seemed that all she could do was to follow a
thought that had been planted in her brain by some alien force.
“She suddenly decided she should go and throw herself in front of a car,
that this was the only answer. It was as if there was nothing out there
apart from the car. . . . She didn’t think of her partner or child. She was
walking out the door when the phone went. This stopped the tunnel of
suicidal ideation.

“She later became distraught at what she had nearly done and guilty that she
had not thought of her family.”

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6/28/2000 – Antidepressant medication use and breast cancer risk

As most of you have already read in my book, Dr. Lorne Brandes linked
antidepressants to cancer in a 1992 study. Now we have additional evidence
that this is happening with one of the leading cancer killers in women –
breast cancer. This study indicates that long term use is the biggest culprit
in breast cancer with 2 years of use of the older tricyclic antidepressants ev
en doubling the rate of cancers and Paxil showing a substantial increase as
well. “Use of tricyclic medications for greater than 2 years, however, may be
associated with a twofold elevation, and use of paroxetine [Paxil] may be
associated with a substantial increase in breast cancer risk.”

We are always grateful to have any of you update us on important issues such
as this so that we can notify others. A special thank you goes out to our
Norwegian director, Svein Reseland, for updating us on this study and for the
assistance he has contributed over the years. It is a pleasure to work with
him.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
___________________________

Am J Epidemiol 2000 May 15;151(10):951-7 Related Articles, Books

Antidepressant medication use and breast cancer risk.

Cotterchio M, Kreiger N, Darlington G, Steingart A

Division of Preventive Oncology, Cancer Care Ontario, Toronto, Canada.

[Medline record in process]

Experimental and epidemiologic studies suggest that antidepressant medication
use may be associated with breast cancer risk. This hypothesis was
investigated using a population-based case-control study; cases diagnosed in
1995-1996 were identified using the Ontario Cancer Registry, and controls
were randomly sampled from an Ontario Ministry of Finance database. Data were
collected using a self-administered questionnaire, and multivariate logistic
regression was used to estimate odds ratios and 95% confidence intervals.
Adjusted odds ratio estimates ranged from 0.7 to 0.8 and were not
statistically significant for “ever” use of antidepressants, tricyclics, and
selective serotonin reuptake inhibitors. Compared with no antidepressant use,
use of tricyclic antidepressants for greater than 2 years’ duration was
associated with an elevated risk of breast cancer (odds ratio (OR) = 2.1, 95%
confidence interval (CI): 0.9, 5.0). Of the six most commonly reported
antidepressant medications, only paroxetine use was associated with an
increase in breast cancer risk (OR = 7.2, 95% CI: 0.9, 58.3). Results from
this study do not support the hypothesis that “ever” use of any
antidepressant medications is associated with breast cancer risk. Use of
tricyclic medications for greater than 2 years, however, may be associated
with a twofold elevation, and use of paroxetine may be associated with a
substantial increase in breast cancer risk.

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The Aftermath of Antidepressants

The Aftermath Of Prozac, Zoloft, Luvox, Fen-Phen, & Many Other Serotonergic Drugs

By Ann Blake-Tracy – Executive Director,
International Coalition For Drug Awareness

Ann Blake-Tracy has specialized for 10 years in adverse reactions to serotonergic medications. She is the executive director of the International Coalition for Drug Awareness (www.drugawareness.org) and author of the book PROZAC:PANACEA OR PANDORA?

WARNING: IT SHOULD BE NOTED THAT A GRADUAL TAPERING OFF OF MEDICATIONS IS SAFEST WITHDRAWAL METHOD TO AVOID SERIOUS WITHDRAWAL EFFECTS

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Note: Keep in mind that these drugs are all serotonergic agents and clones or “copy cat” drugs of Prozac – the first SSRI antidepressant introduced to the market in America. Basically what applies to one, applies to the others. For instance we have more data out on Prozac because it has been around longer, but as the mode of action is the same for all of these meds the effects will be the same for the other drugs on this list as it is for Prozac. If we are discussing one drug, similar effects would be expected from any other company’s version of the drug. In fact it would be more honest to give them the titles of Prozac #1, Prozac #2,Prozac #3, etc. rather than the brand names they have been given, from the second clone, Zoloft, to the latest Prozac clone, Celexa.

My concern is that each new SSRI introduced seems to be a little stronger on serotonin reuptake and therefore potentially more dangerous. And the all too common practice of going from one SSRI to another blocks additional receptors and magnifies the harmful effects of these medications. It is crucial to learn that according to medical research the theory behind this group of drugs is invalid. Known as serotonin reuptake inhibitors. They are designed to block serotonin in the brain, thereby increasing brain levels of this neurotransmitter. Yet for three decades researchers have been intensely interested in serotonin because LSD and PCP produce their psychedelic effects by mimicking serotonin. Elevated serotonin is found in: psychosis or schizophrenia, mood disorders, organic brain disease, mental retardation, autism and Alzheimer’s. While low levels of the metabolism of serotonin (which also produces high serotonin), are found in those with: depression, anxiety, suicide, violence, arson, substance abuse, insomnia, violent nightmares, impulsive behavior, reckless driving, exhibitionism, hostility, argumentative behavior, etc. The drugs increase serotonin and decrease the metabolism of serotonin leading to any and all of the above results. This information is extremely crucial for patients and physicians to learn as soon as possible. We have a high rate of use of these drugs nationwide. Raising serotonin and lowering the metabolism of serotonin in such a large number of people can produce very serious, widespread and long term problems for all of society.

So why are we now in the 90’s being told that increased serotonin is good for us? Is it because it is good for the pocketbooks of the manufacturers? One manufacturer is running full page newspaper and magazine ads and half hour TV infomercials to bring in over $7 million daily, while on the other hand they are settling Prozac suicide cases for huge amounts of money in exchange for silence from victim’s families on the details of those settlements. The silence in the court cases insures that the drug will be allowed to finish out its patent time, thus bringing in the highest possible profits for the company. They know that with $7 million coming in daily, they can afford to settle a large number of lawsuits and still come out “smelling like a rose” financially.

Eli Lilly has been sued for Prozac related deaths in numerous state and federal courts with most of these cases being settled or dismissed – many were dismissed due to the unethical manipulation of the Wesbecker verdict
(see time line for details).

We have witnessed no decrease in suicide, but increases in murder/suicide, suicide, unwed pregnancies, domestic violence, manic-depression, MS, hypoglycemia, diabetes, bankruptcies, divorce, mothers (parents) killing children, road rage, school shootings, cancer, Chronic Fatigue Syndrome, and Fibromyalgia since these serotonergic drugs have become so popular and I relate it directly to the effects of these drugs.

The death toll has continued to climb drastically since I wrote PROZAC: PANACEA OR PANDORA? Some of the cases you may be familiar with are:

1. Mr. and Mrs. Phil Hartman (Zoloft), Prozac was found in the van of Mark Barton, the Atlanta day trader, who recently killed his family and others in a shooting spree before taking his own life;
2. Neal Furrow, in LA Jewish school shooting was reported to have been court ordered to be on Prozac along with several other medications;
3. The Salt Lake Family History Library shooting;
4. School shootings in Littleton, Colorado (Luvox), Atlanta, Georgia, Springfield, Oregon (Prozac), and Caldwell, Idaho;
5. Another boy in Pocatello, ID in 1998 who in seizure activity from Zoloft had a stand off at the school;
6. 15 year old Chris Shanahan (Paxil) in Rigby, ID who out of the blue killed a woman;
7. The shooting at the lottery in Connecticut last spring by Matthew Beck (Luvox) that left five dead in a murder/suicide;
8. The New York City Subway bombing by Edward Leary (Prozac);
9. Nick Mansies (Paxil) in New Jersey who was convicted of killing a little boy who was selling cookies door to door;
10. In Orange County, CA Dana Sue Gray (Paxil) who co-workers described as a very caring nurse killed several elderly people;
11. Officer Stephen Christian (Prozac) one of the finest officers on the Dallas Police force, who ran into a police substation shooting at fellow officers and was killed;
12. 13 year old Chris Fetters (Prozac) in Iowa who killed her favorite aunt;
13. David Rothman (Prozac) killed two co-workers and himself at the Dept. of Agriculture in Ingelwood, CA;
14. Williams Evans (Zoloft) shot one co-worker at the Ohio Bureau of Employment Services before shooting himself in Columbus, OH;
15. Winatchee, WA where 43 people were wrongfully imprisoned in a false accusation of sexual abuse “witch hunt” fury started by a child under the influence of Prozac and Paxil;
16. Christopher Vasquez (Zoloft) killed Michael Morrow in Central Park;
17. Megan Hogg (Prozac) duct taped the mouths and noses of her three little girls and took a handful of pills; Vera Espinoza (Prozac) in Randolph, VT shot her small son and daughter before shooting herself;
18. An elderly man (Prozac) in Layton, UT axed his wife and daughter to death;
19. Margaret Kastanis (Prozac) used a knife and hammer to kill her three children before stabbing herself to death;
20. An elderly man (Paxil) in Dallas, TX strangled his wife before shooting himself twice in the chest;
21. Larramie Huntzinger (Zoloft) blacked out and ran his car into three young girls killing two in Salt Lake City, UT;
22. Mary Hinkelman (Prozac), a nurse in Baroda, MI shot her two small daughters and her sister before shooting herself;
23. Lisa Fox (Prozac) shot her small son and her dog before shooting herself in Brighton, MI;
24. Debi Louselle (Zoloft) shot daughter and then herself in Salt Lake City, UT;
25. A father in Wyoming shot his wife, daughter and baby grand-daughter then himself after only days on Paxil;
26. A mother (Prozac) in Pleasant Grove, UT killed her 17 year old son with a sledge hammer while he slept before she attempted suicide by drinking Drano;
27. Larry Butz, a superintendent of schools in Ames, IA shot his wife, son and daughter before shooting himself – many cases pending in court are not mentioned.

This is only a handful of MANY, MANY more cases – there would not be room for anything else if I continued listing the cases.

A few additional famous victims: Princess Di (Prozac) and Dodi Fayed -via their driver Henri Paul (Prozac), Monica Lewinsky (Prozac, Zoloft, Effexor, Serzone and Phen-Fen), Chris Farley (Prozac), Pres. Clinton’s ex-partner Jim Mc Dougal (Prozac), Abby Hoffman (Prozac), Del Shannon (Prozac), Danielle Steele’s son (Prozac), INXS singer Michael Hutchence (Prozac), Sarah – Dutchess of York (Phen-Fen)

The latest figures show Prozac has about 44,000 adverse reports filed with the FDA. Out of those reports there are about 2,500 deaths with the large majority of them linked to suicide or violence.

The suicide statistics relating to women are shocking. According to the CDC there are about 30,000 suicides yearly in the United States. Out of those about 6,000 are women – a ratio of about 4.3 to 1, male to female. About twice as many women as men are treated for depression demonstrating that generally men are more than 8 times as lethal in their suicidal gestures as women. Women were known to use less lethal means until the SSRI antidepressants hit the market. But on Prozac and Paxil, women committed 40% of the suicides – many were strikingly violent and clearly leaving no
means for rescue. (Remember that because Prozac was the first of this group of drugs its track record gives us a vision of what is to come with other serotonergic antidepressants, especially when they are so powerful in the reuptake of serotonin.)

TIME LINE OF CRITICAL INFORMATION DISCOVERED SINCE THE BOOK:

*NOTE: Any documents beginning with PZ are Lilly documents on Prozac which have been ferreted out by attorneys and are now being used in lawsuits against the drug company. (Christian vs. Eli Lilly, by Vickery & Waldner, Houston, TX)

* Mid 1950’s: Dr. Felix Sulman began his research on those who suffer from high serotonin levels because of an inability to metabolize serotonin. He found that serotonin is a stress neuro-hormone leading even rabbits, the most docile of creatures, to be aggressive. He coined the term “serotonin irritation syndrome.” He found that those who were unable to break down serotonin would have the levels increase. They were in effect being poisoned by the serotonin produced by their own bodies, the irritation victims suffered from migraines, hot flashes, irritability, sleeplessness, pains around the heart, difficulty in breathing, a worsening of bronchial complaints, irrational tension and anxiety. . . horrifying nightmares. It also caused his volunteers to sleep badly – that is, always on the edge of consciousness so that they were not properly rested – and to wake after only a few hours of sleep.” (sleep apnea) He also found it caused pregnant women to abort.
* October, 1977: Slater, et.al., Inhibition of REM Sleep by Fluoxetine, a Specific Inhibitor of Serotonin Uptake, October 1977, at p. 385 – Prozac was found to affect sleep habits, specifically to suppress deep sleep, which the scientists call REM (rapid eye movement) sleep in cats. By the fourth day of drug treatment the cats receiving the larger doses, which had been friendly for years, began to growl and hiss. After cessation of the drug treatment, the cats returned to their usual friendly behavior in a week or two; those on the higher doses recovering more slowly. – – 1977: [PZ 1298 1999] “A total of six dogs from the high dose group were removed from treatment … due to severe occurrences of either aggressive behavior, ataxia, or anorexia.”]
* July 31, 1978: [PZ1061 1025-28, July 31, 1978] Human subjects began to be used by Lilly in controlled clinical trials. The first group of patients showed no improvement in their depression, but there were a “large number of reports of adverse reactions.” The first human to receive Prozac experienced “dystonia resembling an extrapyramidal reaction” – an uncontrollable, Parkinson-like shaking or trembling.
* July 23, 1979 [PZ 1297 969] The clinical studies in depression showed that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off drug. In future studies the use of benzodiazepines to control the agitation will be permitted.”
* August 3, 1979: The clinical trials excluded patients who had serious suicidal risk. [E.g. control #001519, IND Protocol No. 14, August 3, 1979; PZ1135 695, July 2, 1986 memorandum of Dr. Wernicke].
* December 17, 1984: [PZ 65 449, report of Lilly to FDA] Lilly reported to the FDA that benzodiazepines and other sedatives were given with Prozac throughout the clinical trials. This was to help offset the stimulant effect of the drug. In a memorandum of Lilly scientist Charles Beasley [PZ 541 2007-08] issues of “agitation vs. sedation” and concomitant sedative medications like benzodiazepines (to control the agitation) are discussed. Concerns are that agitation in a suicidal patient can induce suicide.
* March 3, 1986 Lilly controlled the flow of information to the FDA and decided that suicide data on Prozac should not be evaluated, “in the safety-update for the FDA the number of suicides and suicide attempts will not be especially evaluated.” [PZ 879 1966, March 3, 1986 telex]
* September 12, 1986: German BGA very concerned with the risk of suicide and ultimately approved Prozac on the condition that physicians be warned of the risk of suicide and told to consider using sedatives and closely monitor patients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299, September 12, 1986] Lilly actually warned physicians in Germany and other countries that this measure “can be necessary” to minimize the risk of suicide, [PZ 1341 402, December 6, 1989 German warning; PZ 2469 490]
* February 7, 1990: In response to the Harvard study, Teicher, et al., Lilly’s top scientist, Leigh Thompson, told his fellow executives that “Lilly can go down the tubes if we lose Prozac”. [PZ 1941 827, February 7, 1990]. In the ensuing months Dr. Thompson spoke frequently with his principal FDA regulator about the issue, once at 6:15 in the morning. [PZ 391 1959, July 18, 1990]. Lilly later described the man as “our defender”. [PZ1941 2256, September 12, 1990]
* May 29, 1990, Lilly added “suicidal ideation” in the section dealing with post-marketing reports. [PZ883 562, July 26, 1990 memorandum]
* September 14, 1990: Contrary to the advice of his staff, Dr. Thompson told the Eli Lilly Board of Directors that suicide and hostile acts were probably, caused by the patients’ underlying disorders rather than Prozac. [PZ542 2101, September 14, 1990; PZ4002 889, Board Minutes]. The staff was concerned because they knew that this issue was never studied during the clinical trials.
* September 11, 1990: Note from Dr. Bruce Stadel, Chief of the Epidemiology Branch, attaching an analysis done by Dr. David Graham, Section Chief within the Epidemiology Branch, of Lilly’s July 17, 1990 submission to the FDA on the Prozac/suicidality/violence issue. The following factors were (a) brought to the attention of those in the higher echelons of the FDA, but (b) ignored, discounted or “trashed” by them: #1 Lilly’s analysis improperly excluded 76 out of 97 suicides; as Dr. Stadel expressed it, “[i]t is inappropriate in a safety analysis to exclude such a large proportion of case”; #2 Lilly admitted that its clinical trials “were not designed for the prospective evaluation of suicidality” and that “[i]n these trials, patients with current suicidal ideation were excluded”; #3 Lilly admitted that the HAMD-3 rating scale it used to assess suicidality in clinical trials was inadequate; and that Lilly’s statements about violence only demonstrated “how great under-reporting is” and that “[t]he actual data showed a higher percentage of treatment-emergent suicidality among fluoxetine (2.9% than tricyclic (0.8%) patients . . . [which percentage] was similar to that reported by Teicher.”
* July 1, 1992: A study lead by Dr. Lorne Brandes of the Manatoba Institute of Cell Biology in Winnipeg, Canada was published in CANCER RESEARCH linking the two most popular anti-depressants, Elavil and Prozac to cancer.
* 1994: A study headed by Howard Markell published in The Journal of Pediatrics showed LSD flashbacks and LSD reactions induced by Prozac.
* June 9, 1994: The New York Review of Books article by Dr. Sherwin Nuland slams Peter Kramer for pushing Prozac in his book Listening to Prozac. He pointed out that all docs are taught in med school this little poem about serotonin: “This man was addicted to moanin’, confusion, edema, and groanin’, intestinal rushes, great tricolored blushes, and died from too much serotonin.” He listed constriction of lungs and intestines, diarrhea, wheezing, flushing, mental confusion, tightening of bronchioles, and lessening conscious control over behavior from increases in serotonin. “Moreover, . . . it is still too early to arrive at a reliable estimate of possible dangers that may appear in the long term,” and 15% dropped out of the clinical trials on Prozac because of adverse reactions. He also discussed the similarity of serotonin to the psychedelics like LSD and PCP.
* November, 1994: Krystal JH, Webb E, Cooney N, et al., “Specificity of Ethanol-like Effects Elicited in Serotonergic and Noradrenergic Mechanisms,” ARCHIVES OF GENERAL PSYCHIATRY, Vol. 51, Issue 11, pgs 898-911, 1994 demonstrated that an increase in brain levels of either of two neurotransmitters, serotonin or noradrenalin, produces:
#1 a craving for alcohol,
#2 anger,
#3 anxiety.
They found this to be especially true for those who have a history of alcoholism. An increase serotonin in turn increases noradrenalin. Numerous reports have been made by reformed alcoholics who are being “driven” to alcohol again after being prescribed a serotonergic drug. And many other patients who had no previous history of alcoholism have continued to report an “overwhelming compulsion” to drink while using these drugs.

A few personal accounts:

#1 A young woman, a recovering alcoholic, reported that during the eight month period she had been using Prozac she found it necessary to attend AA meetings every day in order to fight off the strong compulsions to begin drinking again.
#2 In the Southeastern United States a middle aged psychologist, also a recovering alcoholic, after being prescribed Prozac, found herself needing to attend AA meetings morning, noon, and night to keep from destroying the sobriety she had achieved.
#3 A young father, who was Mormon and had never before in his life used alcohol, found himself drinking Ever Clear and exhibiting bizarre as well as violent behavior, after being prescribed Prozac and Ritalin.
#4 A young mother who had never used alcohol before began drinking large amounts within weeks of being prescribed Prozac and quickly found herself committed to a mental institution due to the psychotic behavior that resulted. Added to her Prozac prescription were anti-psychotic meds and electric shock treatments. She then began to experience seizures and was started on anti-seizure meds.
#5 A concerned neighbor reported her friend was drinking straight Vodka on a regular basis after being prescribed Zoloft. #6 A daughter reported her father, sober for 15 years, began drinking again on Prozac.

* December, 1994: Not guilty verdict on Wesbecker wrongful death suit against Lilly’s Prozac.
* Treatment emergent suicidality with Prozac has been demonstrated to be two to three times higher than any other anti-depressant. (Jick, et al., Antidepressants and Suicide)
* May, 1995: Judge John Potter who presided over the Wesbecker case filed documents to demand that Lilly be forced to disclose the secret deal they made with the plaintiffs to withhold very damaging evidence in exchange for settlement. In his pleading to the court Potter stated, “Lilly sought to buy not just the verdict, but the court’s judgment as well.” Potter accused Lilly of “giving the verdict the widest possible publicity” accompanied by the claim that Lilly had “proven in a court of law that Prozac was safe.” Furious with Lilly’s attempt to turn his courtroom into an advertising agency for Prozac, he claims his motion reflects “the court’s duty to protect the integrity of the judicial system.” He believes, as do prominent legal ethicists, that a full and open disclosure of the terms of the settlement is a necessary public safety issue.
* July, 1997: Mayo Clinic found that the increased serotonin, which produces blood clotting, was causing a gummy glossy substance to build up on heart valves. Dr. Heidi Connolly with the Divisions of Cardiovascular Diseases and Internal Medicine, who headed the study stated, “We do know that fenfluramine and phentermine [Fen-Phen] alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury.” Fenfluramine produces a rapid release of serotonin, inhibits serotonin reuptake, and may also have receptor agonist activity. The study’s revelations should send a loud and very clear warning throughout the medical community concerning all serotonergic medications.
* August 25, 1997: Letter to Ann Blake-Tracy, “I caught the last part of your presentation on Radio Station KEX, Portland, while flipping through the dial last night. I was flabbergasted to hear you speak of the horrible potential side effects from Prozac, which I have been taking for approximately four years, particularly since I have been diagnosed recently with cardiomyalgia, severe artery disease, congestive heart failure and also Fibromyalgia. (I was a very “well” person prior to taking the Prozac and am now exhausted all the time, with horrible aching joints and considerable pain and a massive heart problem.) The adverse cardiovascular effects from Prozac, the one drug in this class of drugs out long enough to have somewhat of track record, are listed in the drug information sheet put out by the manufacturer. The “frequent” effects listed are hemorrhage and hypertension. The “infrequent” effects include very serious adverse effects: congestive heart failure, myocardial infarct, tachycardia, angina pectoris, arrhythmia, hypotension, migraine syncope and vascular headache.
* September, 1997: Redux and Phen-Fen were pulled from the market.
* October 20, 1997: Dr. Candace Pert, Research Professor at Georgetown University Medical Center, past head of the brain chemistry department at the National Institute of Health, and author of the new book, MOLECULES OF EMOTION, sounded an alarm in TIME, October 20. She stated, “I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.”
As we are being led to believe these drugs produce effects only in the brain, Dr. Pert accuses the medical profession of oversimplifying the action of these drugs and adds that “the public is being misinformed about the precision of these selective serotonin-uptake inhibitors.” It is critical that both physicians and patients be made aware of these adverse physical reactions. She points out that the medical profession not only oversimplifies the action of these drugs in the brain, but “ignores the body as if it exists merely to carry the head around!” And that, “these molecules of emotion regulate every aspect of our physiology.” The body plays a very significant role in how we feel and act the way we do. This fact can no longer be ignored. Serotonin and serotonin receptors exist throughout the body, as well as the brain, and every aspect of the body’s physiology is affected by these serotonergic medications. In fact approximately 90% of the body’s serotonin is produced in the intestinal tract. According to Dr. Michael Gershon of New York’s Columbia Presbyterian, this is the reason why Prozac produces so many gastrointestinal side effects.
* March, 1998: Two new studies published. One that shows Prozac so strongly inhibits one particular serotonin receptor that this produces both obesity and seizures and the other discusses the blockage of muscle and neuronal nicotinic acetylcholine receptors indicating interactions between the serotonergic and cholinergic systems in the central nervous system.
* April, 1998: Our next generation of guinea pigs – one month before a 15 year old on Prozac, Kip Kinkel, in Springfield OR killed his parents and two classmates the American Psychiatric Association and the American Academy of Pediatric Psychiatrists asked the FDA to consider the serotonergic antidepressants for use in children as young as two and drugs for anxiety, aggression and manic depression in babies only one month old! The use of Prozac among young children ages 6 – 12 has increased an alarming 400% from 1995 (51.000 new prescriptions) to 1996 (203,000 new prescriptions).
* June, 1999: CLINICAL PSYCHIATRY NEWS reported that Dr. Malcolm Bowers a psychiatrist at Yale has found that physicians are not paying enough attention to patient factors that could make initiation of SSRIs dangerous. He found that “SSRI-induced psychosis has accounted for 8% of all general hospital psychiatric admissions over a recent 14-month period.” And “What is surprising is that this particular group of side effects is really underplayed.” (The 8% figure represents over 150,000 SSRI induced psychotic breaks per year!!!!!!!)

WARNING: Children so often get coughs and colds, yet using a cough or cold medication with dextromethorphan could cause the serotonin syndrome, a very serious and potentially fatal adverse reaction and/or produce PCP reactions.

Serotonin syndrome remains an often misdiagnosed or unrecognized fatal reaction due to the medical profession being so uninformed about this drug-induced disorder.

Developing brains are far more vulnerable than adult brains and brain damage generally becomes more apparent after the brain is fully developed, rather than immediately. Increases in cortisol produce brain damage while medical research shows that one single 30mg dose of Prozac DOUBLES the level of cortisol. This drastic increase in cortisol causes a multitude of serious physical reactions including impairment of linear growth, as well as impairing the development and regeneration of the liver, kidneys, muscles, etc. In light of so many unspeakable tragedies, I have grown weary of all the silly philosophical discussions we have heard since Kramer’s LISTENING TO PROZAC came out. Patients are dying or having their health destroyed mentally as well as physically (when do we begin to discuss the very serious physical side effects associated with high levels of serotonin?). These patients and their families are frantically searching for answers while this research sits right under our noses and could easily be made available to them. The widespread use of Prozac and its clones is not a statement of either their safety or their effectiveness. It is a statement about the effectiveness of an infinite marketing budget and incredible advertising campaign! These drugs have very serious physical side effects, as well as dangerous psychiatric side effects.

To prevent further tragedy this medical research must be acknowledged and addressed in headline news without delay rather than remain buried in seldom read medical research documents as has been the case in the past with other mind- altering medications, once thought to be safe, which were subsequently prohibited by law, i.e. LSD, PCP, cocaine, etc.

PRAISE FOR PROZAC: PANACEA OR PANDORA?

“I started having bad reactions . . . Oct ’96 I found Prozac to be causing joint and muscle pain itself . . . signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said against it until I got problems (thought it was saving my life, while all the time it was insidiously and interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can’t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people who are prepared to fight for the truth for the benefit of mankind.” Oct. 1998 note from a British nurse

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the groundwork to educate other professionals and the general public about the new SSRI antidepressants – Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.” (Jeff Wise, psychologist, Salt Lake County Drug and Alcohol Abuse )

“In 15 years of reading books on drugs I have never read a book with more information or so well documented as PROZAC: PANACEA OR PANDORA?” (Dr. Kevin Millet, Bountiful, UT)

“As I lecture to physicians nationwide on the medical use of psychoactive drugs PROZAC: PANACEA OR PANDORA? always accompanies me in my brief case.” (Dr. Bruce Woolley, neuropsychopharmacologist, Brigham Young University)

“I found PROZAC: PANACEA OR PANDORA? fascinating reading and the most complete analysis of the various factors pertaining to the Prozac controversy.” (Attorney Donald Sokol, Susanville, CA)

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information , . . .. this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials from hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects from the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going off these meds.” (Nick Jameson, Prozac patient)

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.” (Dr. Paul Kennedy, N.J.)

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.” (Margaret McCaffery, N.Y. who lost her daughter, a neurosurgeon, in a Prozac suicide)

“The work Ann Blake-Tracy is doing is very important and she is truly a heroine.” (Dr. Candace Pert, Washington, DC, one of the two developers of the serotonin binding process which made possible the development of the serotonergic drugs. Dr. Pert has boldly stated, speaking of these serotonergic medications, “I am alarmed at the monsters I created!”)

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

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09/21/1999 – Prozac Found at Wedgwood Baptist Killer’s House

This just released today.

Prozac found at Wedgwood Baptist killer’s house
By Kathy Sanders
Star-Telegram Staff Writer

FORT WORTH — A doctor had prescribed the anti- depressant drug Prozac
for Larry Gene Ashbrook, but investigators are unsure whether he had
been taking it when he killed seven people and then himself in a
southwest Fort Worth church last week, police said yesterday.

http://www.star-telegram.com/news/doc/1047/1:TOPSTORY/1:TOPSTORY092199.html

Star-Telegram

By Kathy Sanders,  Star-Telegram Staff Writer

Updated: Tuesday, Sep. 21, 1999 at 08:16 CDT

FORT WORTH — A doctor had prescribed the anti-depressant drug Prozac for Larry Gene Ashbrookbut investigators are unsure whether he had been taking it when he killed seven people and then himself in a southwest Fort Worth church last week, police said yesterday.

Fort Worth police Lt. Mark Krey, who is heading the investigation into the largest mass shooting in the city’s history, said police found a Prozac vial with Ashbrook’s name and want to ask doctors why it was prescribed.

Krey said Ashbrook, 47, may have slipped into insanity after his 85-year-old father died in July.

“The level of paranoia within his life had advanced to an extreme stage,”  Krey said. “We’re investigating the possibility that with the death of his father, Mr. Ashbrook stopped taking medication. We believe when he lost his  father, who was his anchor to reality and his caretaker to ensure he took  his medication, he lost any connection to reality.”

Also yesterday, police said a homemade pipe bomb exploded in Wedgwood Baptist Church with enough force that it sent a piece of shrapnel hurtling the sanctuary.

But rather than blasting out into a sanctuary where more than 150 worshippers were taking part in a youth service, most of the shrapnel shot toward the ceiling and then rained down. No one was seriously injured by the shrapnel.

“We are very blessed in the manner in which it detonated … or it would have caused serious bodily injury,” Krey said.

Prozac is commonly used to treat various forms of clinical depression, including depression in children, as well as bulimia and obsessive-compulsive disorder.

Dr. Peter Kowlaski, a psychiatrist in private practice in Fort Worth and former medical director for Mental Health- Mental Retardation Services of Tarrant County, said the medical community generally views Prozac as a good anti- depressant that does not contribute to, or prevent, violent behavior.

“The person who is ill will sometimes act out violently, but most people with psychiatric illnesses are not likely to act violently,” he said. “Those who do most often do evil independent of their psychiatric conditions.”

Police found the Prozac bottle in Ashbrook’s Forest Hill home. FBI officials said they also found nine vials of prescription drugs for Jack Ashbrook, who died after a battle with cancer, as well as a diary in which the father documented his medication, said spokeswoman Marjorie Poch.

“The writing changed in the last couple of weeks of the diary. It’s only speculation, but he [Larry Ashbrook] may have started taking his father’s medication,” she said. “Either that or he started recording when his father took the pills for him.”

On Wednesday night, Ashbrook walked into the Wedgwood church, where a youth  rally was under way, and began shooting people, police said.

Killed were Kristi Beckel, 14; Shawn Brown, 23; Susan Kimberly Jones, 23;  Cassandra Griffin, 14; Joseph “Joey” Ennis, 14; Sydney Browning, 36; and  Justin Ray, 17. Seven others were injured.

The final three victims were laid to rest yesterday, but Ashbrook’s body remained unclaimed at the Tarrant County Medical Examiner’s Office.

Aaron Ashbrook, his brother, said the family is completing funeral arrangements, but declined to comment further.

“I think there probably has been more said than there needs to be, and a lot  of it’s untrue,” he said.

He declined to elaborate.

“It wouldn’t make any difference,” he said. “I think the damage has already been done.”

Investigators sorted information yesterday from nearly 70 depositions taken from people the night of the shooting, reinterviewed the wounded and tried to trace Ashbrook’s final, fatal steps.

“Investigators are going through a number of depositions to determine the  exact sequence of events,” said homicide Sgt. Dave Loftis. “We want to know, first of all, specifically what happened and how everything went down that day.”

But the answer to the most- asked questions — what set Ashbrook off and why did he choose Wedgwood — may never come.

“I don’t have any motive right now,” Loftis said. “I don’t know if we’ll ever have an answer to those questions. If we can, we certainly will get them. It’s like any of those senseless acts of violence — there aren’t any answers. And can any motive explain it and make sense of it?”

In his writings, Larry Ashbrook details a vast, unspecified conspiracy against him by law enforcement agencies and others. His brother described him to Wise County sheriff’s deputies as a paranoid schizophrenic.  But the  state mental health system said last week that it had no record of any contact with Ashbrook.

Krey said Ashbrook apparently was such a loner that few people have been found to help explain his activities.

“I believe we won’t find anybody because there is nobody to find. And that is consistent with the mental illness he appeared to be afflicted with,” he said.

Inside the church, Ashbrook fired all six rounds from a .380- caliber semiautomatic handgun, and then fired up to 50 more shots from a Ruger 9 mm semiautomatic pistol, officials said.

Six of the seven people who died were killed by gunshot wounds in the head, autopsy reports show. The seventh was shot in the back.

Ashbrook shot himself with the Ruger, police said. He was apparently alive in a back pew when paramedics rushed into the sanctuary, but was pronounced dead a short time later, police said.

Justin Ray and a woman videotaped Ashbrook’s rampage, police said.  Officials in Forest Hill said Ashbrook may also have made a futile effort to contaminate the city’s water system.

“He put concrete in the commodes and, working for the city, I wanted to make sure he didn’t do something else,” Public Works Director Michael Duehring
said.

“I wanted to make sure he did not contaminate our water system. I can’t go any further than that and tell you what he did, but he didn’t do any damage.”

FBI officials inspected plumbing in Ashbrook’s home Thursday but did not consider the threat serious, Poch said.

“The agent said it looked like he was just trying to mess up the inside of the house,” she said. “The agent who was out there said he had ripped off the shower head and neck and put one of those paper cones and a quart of motor oil to back down into the pipes. He said it was stuck in there still.”

Staff writers Bob Mahlburg and Carolyn Poirot contributed to this report.

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8/8/1999 • Antidepressant discontinuation-related mania: critical prospective observation and theoretical implications in bipolar disorder.

8/8/1999 • Antidepressant discontinuation-related mania: critical prospective observation and theoretical implications in bipolar disorder.

Goldstein TR, Frye MA, Denicoff KD, Smith-Jackson E, Leverich GS, Bryan AL, Ali SO, Post RM
Department of Clinical Psychology, University of Colorado, Boulder, USA.

J Clin Psychiatry 1999 Aug 60(8); 563-7 quiz 568-9

These 6 cases suggest a paradoxical effect whereby antidepressant discontinuation actually induces mania in spite of adequate concomitant mood-stabilizing treatment. These preliminary observations, if replicated in larger and controlled prospective studies, suggest the need for further consideration of the potential biochemical mechanisms involved so that new preventive treatment approaches can be assessed.

Antidepressant discontinuation-related mania: critical prospective observation and theoretical implications in bipolar disorder.

Goldstein TR, Frye MA, Denicoff KD, Smith-Jackson E, Leverich GS, Bryan AL, Ali SO, Post RM
Department of Clinical Psychology, University of Colorado, Boulder, USA.

J Clin Psychiatry 1999 Aug 60(8); 563-7 quiz 568-9

These 6 cases suggest a paradoxical effect whereby antidepressant discontinuation actually induces mania in spite of adequate concomitant mood-stabilizing treatment. These preliminary observations, if replicated in larger and controlled prospective studies, suggest the need for further consideration of the potential biochemical mechanisms involved so that new preventive treatment approaches can be assessed.

BACKGROUND: Development of manic symptoms on antidepressant discontinuation has primarily been reported in unipolar patients.
This case series presents preliminary evidence for a similar phenomenon in bipolar patients.

METHOD: Prospectively obtained life chart ratings of 73 bipolar patients at the National Institute of Mental Health were reviewed for manic episodes that emerged during antidepressant taper or discontinuation. Medical records were utilized as a corroborative resource. Six cases of antidepressant discontinuation-related mania were identified and critically evaluated.

RESULTS: All patients were taking conventional mood stabilizers. The patients were on antidepressant treatment a mean of 6.5 months prior to taper, which lasted an average of 20 days (range, 1-43 days). First manic symptoms emerged, on average, 2 weeks into the taper (range, 1-23 days). These 6 cases of antidepressant discontinuation-related mania involved 3 selective serotonin reuptake inhibitors (SSRIs), 2 tricyclic antidepressants (TCAs), and 1 serotonin-norepinephrine reuptake inhibitor. Mean length of the ensuing manic episode was 27.8 days (range, 12-49 days). Potential confounds such as antidepressant induction, phenomenological misdiagnosis of agitated depression, physiologic drug withdrawal syndrome, and course of illness were carefully evaluated and determined to be noncontributory.

CONCLUSION: These 6 cases suggest a paradoxical effect whereby antidepressant discontinuation actually induces mania in spite of adequate concomitant mood-stabilizing treatment. These preliminary observations, if replicated in larger and controlled prospective studies, suggest the need for further consideration of the potential biochemical mechanisms involved so that new preventive treatment approaches can be assessed.

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07/19/1999 – My antidepressant made me do it! – Hartman estate says

The following article makes its first appearance today (7/19/99) on
salon.com:

My antidepressant made me do it!
The Hartman estate says Zoloft was to blame for a murder-suicide.
By Rob Waters

(http://www.salon.com/health/feature/1999/07/19/zoloft/index.html)

My antidepressant made me do it!

The Hartman estate says Zoloft was
to blame for a murder-suicide.

– – – – – – – – – – – –
By Rob Waters

July 19, 1999 | It was May 1998, and comedian Phil Hartman and his wife, Brynn, were planning a party. Their son, Sean, was soon turning 10 and they wanted to make it special with a bash at Planet Hollywood. Brynn was inviting her son’s friends, including some of his classmates from his school in Encino.

In mid-May she called Kathryn Alice, the mother of one of Sean’s friends, to get her address. Sean and Calvin, Kathryn’s son, played together and had visited each other’s homes. Through their sons, the moms had gotten to know each other, too. They chatted on the phone, and Brynn confided that things were tough. “She said she was barely hanging on by a thread,” Alice recalls. “I told her things will get better, but she said ‘I don’t know.'”

The invitation soon arrived in the mail, but the birthday party never happened. On May 28, at about 2:30 a.m., Brynn Hartman returned home from a night out with a female friend. As Sean and his sister, Birgen, slept in their rooms, Brynn entered the master bedroom and shot her sleeping husband three times. Four hours later, with police in the house and friends listening outside, Brynn lay down on the bed next to Phil’s body and pulled the trigger once more, killing herself.

How could this happen? Why did a woman who was, by all accounts, a devoted and protective mother, deprive her children of their parents? In the days after the killings, the tabloids and mainstream press ruminated over the problems in the couple’s often stormy relationship, speculating that Phil was preparing to leave her, or that she had relapsed into an old cocaine addiction. People magazine reported that she had recently started drinking again after 10 years of near-sobriety and had checked into an Arizona rehab clinic earlier in the year. Indeed, toxicology reports cited in press accounts indicate that at the time she died, Brynn Hartman had both cocaine and alcohol in her system.

But the couple’s family and their lawyers have another answer: Zoloft made her do it.

In late May 1999, one year after the deaths, attorneys for the Hartmans’ estate and children filed a lawsuit against Pfizer, the pharmaceutical giant that makes Zoloft, a new-generation antidepressant similar to Prozac. The suit contends that Brynn Hartman’s violent outburst was caused by a rare but previously documented side effect of the medication that left her agitated, jittery and “out of touch with reality.” It is one of more than 170 wrongful death lawsuits filed against the makers of these new antidepressants since Prozac first hit the market 12 years ago.

The Hartman suit also charges that Arthur Sorosky, the psychiatrist that supplied Brynn Hartman with Zoloft, was not really her doctor and never conducted an evaluation. Sorosky, the complaint alleges, was actually her son Sean’s doctor and gave Brynn medication samples — the kind doled out to physicians by drug company salesmen — “without the benefit of a history and physical examination [or] diagnosis.”

Sorosky’s attorney, Joel Douglas, told Salon Health that his client and Brynn Hartman had “a doctor-patient relationship” and that Sorosky had prescribed the Zoloft in a proper and appropriate way. “From what I understand,” he added, “with cocaine and alcohol in her system, you don’t need to look for Zoloft to understand what happened.”

Original report on murder/suicide: http://www.cnn.com/SHOWBIZ/TV/9805/28/hartman/

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