7/18/2000 – Tonight San Francisco News

Fox news on KTVU, Chan. 2 out of San Francisco
will air a special tonight at 10:00 PM Pacific Time
and again tomorrow night at the same time on the
adverse reactions and long-term reactions to SSRI
antidepressants.

The reporters flew to Salt Lake City two weeks ago
to interview me (Ann Blake-Tracy), along with several victims
of the SSRI antidepressants I have worked with over
the last several years. I am grateful to those
individuals and all the others who offered to be
interviewed for having the courage to share their
experiences in order to prevent these tragedies in
the lives of others.

KTVU also interviewed Andy Vickery for this news
piece. Mr. Vickery’s Houston, TX law firm has been
the leading firm in more SSRI wrongful death suits
than any other law firm that I am aware of in the world.
In case you have missed their link on our site, their
website is located at (www.justiceseekers.com) and
is packed with very informative SSRI material.

Ann Blake-Tracy

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7/17/2000 – Call for Stories and Photos.

Dear ICFDA eGroups subscribers….

This is a rather different message, and a difficult one at that.

As many of you may know, my wife and I lost our 13-year son to
an SSRI-induced suicide three years ago next week.
(drugawareness.org/matthewmiller.html)

In a few weeks we will be going to trial here in Kansas City in
attempt to prove that Pfizer has long known about the
relationship between their drug Zoloft, and violent or suicidal
actions. (information posted at justiceseekers.com)

It most likely will be a long, difficult and personally taxing ordeal.

My wife and I have chosen to pursue this litigation because we
believe there need to be changes in the ways these drugs are
marketed and labeled, especially by doctors who prescribe
off-label to children.

We know we are not going into this alone. We have outstanding
legal representation. We have the prayers of many who have
also suffered. We know that all those who have died on these
medications, and they are far too numerous to mention, stand
with us. (It is no understatement to say that we feel their
presence every day. Perhaps even your own loved ones.) And
we ultimately know that the good Lord blesses our efforts—this
“rising up in righteous anger.”

In the coming weeks, we will have an opportunity to share our
story with many people, especially within the news media. In
fact, we have an important interview with a national news
organization in August.

And that’s why I’m writing.

One of the things that most convinced us that Matt’s medicine
was responsible for his actions were the countless letters we
have received from our website. They still come in every day.
For the most part, they represent a tragic realization that the
“cure” was “cause.”

If you have suffered on SSRI medications, specifically Prozac,
Paxil, Zoloft, Luvox, Effexor, Serzone, Celexa (or any other
serotonergic medicine), please send me a photo and a short
paragraph on a separate piece of 8 1/2″ X 11″ paper stating what
happened. It could be as simple as “My brother took his life on
Zoloft after three weeks of use,” or “I almost lost my life trying to
withdraw from Paxil.” Please use names and addresses and
phone numbers. I want to build a scrapbook to share with the
press.

Perhaps with your help, we can make a difference. And your
help in building this scrapbook will go a long ways to show the
human dimension to this national tragedy.

If you can, please send a photo and short paragraph to me by
August 15, 2000 to:

13920 Garnett
Overland Park, KS 66221

Or if you prefer, email me your photo (preferably as JPEG file)
and paragraph to me at mmiller1@…. I will not be able
to return originals, but I will let you know I’ve received them.

Thank you for your cooperation. Obviously some of you reached
by this email will not have had a personally devastating
experience with these drugs, and for that I am grateful. But, if you
have, please take a moment to help out in this way.

I know this book will make a powerful statement with whomever
we talk to.

Thank you again…Mark and Cheryl Miller

642 total views, 5 views today

7/15/2000 – FDA Warning Comes 40 Years Too Late on Mellaril

We are grateful to our e-group member, Martin Hirschfeld,
and also to Vera Hassner Sharav, President, CIRCARE:
Citizens for Responsible Care & Research, for forwarding
this information to us.
AFTER 40 YEARS OF USE – the FDA has put new
restrictions on the use of the antipsychotic, Mellaril.
Obviously for many patients this strong warning about
life threatening side effects has come 40 years too late!
How many patients would still be alive had the warning
come when it should have – 40 years ago? This should
cause us to ask just how many more drugs are as
damaging or even more dangerous, that we have yet
to be warned by the FDA of their dangers?

For those using SSRIs, note that an additional warning
of contraintication is issued to those using Luvox or another
drug often given in conjunction with SSRIs, propranolol.
Considering the accumulation rate of SSRIs, including
Luvox, the contraindication for Mellaril should include
anyone who has been on Luvox in the recent past
as well. And because psychosis is listed as a “frequent”
side effect of Luvox, the prescribing of an antipsychotic
such as Mellaril could be a fairly common practice
threatening the lives of many.

Dr. Ann BlakeTracy
________________________

New Labeling For Novartis’ Mellaril Reflects Restricted Use

http://www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and
Drug Administration (FDA) has asked Novartis to update
the labeling for its antipsychotic drug Mellaril (thioridazine)
to warn of potentially life-threatening side effects, the
company said on Wednesday.

Thioridazine has been shown to prolong patients’ QTc
interval, an electrocardiogram measurement reflecting
the refractory period of the heart, which can lead to the
potentially fatal ventricular tachycardia known as torsades
de pointes and sudden death, according to the FDA.

As a result, Mellaril is now indicated only for patients
with schizophrenia who either cannot tolerate other
antipsychotic drugs or who fail to respond to them,
the company said.

In addition to changing Mellaril’s label, Novartis will
send letters to about 360,000 US doctors and 60,000
pharmacies apprising them of the FDA’s new position
on the drug, and asking them to share the information
with their patients.

The letters advise that “switching to a different antipsychotic
agent should be considered.”

Mellaril, which was approved in 1959, has already been
eclipsed by newer therapies for many patients, a Novartis
spokesperson told Reuters Health. While the new warnings
threaten to slash sales of the drug even further, “in the short
term, we won’t be discontinuing it,” he said.

The product is also sold by a handful of generic manufacturers,
including Geneva and Mylan.

Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated
with certain other drugs,” including the antidepressant
fluvoxamine [Luvox] and the beta-blocker propranolol, and
is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.

Before being treated with Mellaril, patients should be
evaluated with a baseline ECG and should have their
serum potassium levels measured, the letter adds,
noting that monitoring should be continued throughout
the treatment.

The letter points out that Boehringer Ingelheim’s Serentil
(mesoridazine), which is chemically related to thioridazine,
“also appears to have the capacity to prolong the QTc interval.”

Boehringer Ingelheim and the FDA did not respond to telephone
calls seeking comment.

Copyright © 2000 Reuters Ltd. All rights reserved.
=================================================================
New Labeling For Novartis’ Mellaril Reflects Restricted Use

www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and Drug Administration
(FDA) has asked Novartis to update the labeling for its antipsychotic drug
Mellaril (thioridazine) to warn of potentially life-threatening side

effects, the company said on Wednesday.
Thioridazine has been shown to prolong patients’ QTc interval, an
electrocardiogram measurement reflecting the refractory period of the heart,
which can lead to the potentially fatal ventricular tachycardia known as
torsades de pointes and sudden death, according to the FDA.
As a result, Mellaril is now indicated only for patients with schizophrenia
who either cannot tolerate other antipsychotic drugs or who fail to respond
to them, the company said.
In addition to changing Mellaril’s label, Novartis will send letters to
about 360,000 US doctors and 60,000 pharmacies apprising them of the FDA’s
new position on the drug, and asking them to share the information with
their patients.
The letters advise that “switching to a different antipsychotic agent should
be considered.”
Mellaril, which was approved in 1959, has already been eclipsed by newer
therapies for many patients, a Novartis spokesperson told Reuters Health.
While the new warnings threaten to slash sales of the drug even further, “in
the short term, we won’t be discontinuing it,” he said.
The product is also sold by a handful of generic manufacturers, including
Geneva and Mylan.
Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated with certain
other drugs,” including the antidepressant fluvoxamine and the beta-blocker
propranolol, and is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.
Before being treated with Mellaril, patients should be evaluated with a
baseline ECG and should have their serum potassium levels measured, the
letter adds, noting that monitoring should be continued throughout the
treatment.
The letter points out that Boehringer Ingelheim’s Serentil (mesoridazine),
which is chemically related to thioridazine, “also appears to have the
capacity to prolong the QTc interval.”
Boehringer Ingelheim and the FDA did not respond to telephone calls seeking
comment.

Copyright © 2000 Reuters Ltd. All rights reserved.

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7/7/2000 – FDA Boosts PMS Insanity

Sarafem, what a nice sounding name for such a deadly drug. How many patients
will know that they are really getting Prozac with a different name? Why is a
name change necessary? If it said Prozac on the label, would the patient take
it? We will not know with the FDA allowing Lilly to change Prozac’s name when
being prescribed for this disorder. Giving these SSRIs different brand names
does nothing to change the dangers of these drugs, but much to confuse the
patient about the dangers and just what drug they are really getting. Talk
about “failure to warn”!

For some time now doctors have given SSRI antidepressants for PMS. They have
encouraged patients to take the drugs in the most dangerous manner I am aware
of – taking them for a week or so and dropping “cold turkey,” then doing the
same the following month! Well, if we thought we saw rage before with PMS,
just wait! Now we can see SSRI withdrawal rage every month rather than the
PMS. At least we will see a change in the time it occurs and the intensity,
right? And now we can, with the FDA’s approval, cure PMDD with drug-induced
psychosis, suicide or murder/suicide. What a novel idea!

Sorry about the sarcasm. I guess I have seen too many people die or have
their lives destroyed as a result of using serotonergic drugs. Just how much
longer can these terrible heart rending tragedies be the “acceptable” risk in
anothers’ feeling better due to a drug-induced hase for things like PMS or
shyness? Please someone tell me where the “acceptable” risk is in using these
powerful and very dangerous drugs for such minor health problems when there
are so many simple and harmless natural solutions like Omega 3 oils? It
couldn’t be because those harmless solutions don’t make anywhere near the $30
– $40 million per day that these drugs bring in, could it? It is clear whose
interest the FDA has in mind with this approval.

Ann Blake-Tracy
_________________

FDA APPROVES FLUOXETINE TO TREAT PREMENSTRUAL DYSPHORIC DISORDER

FDA has approved fluoxetine (Sarafem) as the first drug treatment for
Premenstrual Dysphoric Disorder(PMDD), a disorder that causes mood changes
and physical symptoms such as bloating and breast tenderness in women.
Fluoxetine was approved as Prozac in December l987 for treating depression,
and has also been approved for treating obsessive compulsive disorder and
bulimia. The following may be used to respond to questions.

On November 3, 1999, FDA’s Psychopharmacologic Advisory Committee unanimously
recommended approval for fluoxetine to treat women with PMDD. The committee
concluded that fluoxetine was effective for the condition and that PMDD has
well defined, accepted diagnostic criteria. The committee also advised that
the drug should be used only to treat women whose symptoms are severe enough
to interfere with functioning at work or school, or with social activities
and relationships.

According to the American Psychiatric Association Diagnostic and Statistical
Manual (DSM-IV), a diagnosis of PMDD requires that patients experience at
least five of the symptoms that characterize PMDD. PMDD has both affective
(mood) and physical symptoms, and is characterized by depressed mood,
anxiety, tension, affective lability (a tendency to alternate between
cheerful and somber moods), and persistent anger or irritability. Other
features include decreased interest in activities, difficulty concentrating,
lack of energy, change in appetite, headache, joint and muscle pain. The mood
symptoms often cause disturbances in social relationships. Physical symptoms
include weight gain, bloating, and breast tenderness. To support a diagnosis
of PMDD, the symptoms must occur regularly in the luteal phase of a woman’s
cycle, and disappear after onset of menstruation. (The luteal phase
corresponds to the period between ovulation and onset of menstruation.)

Fluoxetine’s effectiveness for the treatment of PMDD was established in two
double-blind placebo-controlled trials. In the first study, 320 patients were
given fluoxetine continuously throughout the menstrual cycle. This study
showed that the drug was significantly more effective than placebo by
measurements of changes in mood and physical symptoms of PMDD. In a second
study, 19 patients were treated with fluoxetine and placebo continuously
throughout the menstrual cycle for a period of three months each. In this
study, fluoxetine was significantly more effective than placebo on a scale
measuring changes in mood, physical and social impairment symptoms.

Sarafem will be marketed by Eli Lilly, of Indianapolis, Ind., with a patient
information brochure and physician labeling specific for the drug’s use. The
drug was not studied in women who were taking oral contraceptives. Common
side effects were similar to those experienced by other fluoxetine users and
included nausea, tiredness, nervousness, dizziness and difficulty
concentrating.

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6/29/2000 – $29M Awarded To 2 Fen-Phen Users

Jury Awards $29M To Fen-Phen Users

June 29, 2000 2:15 am EST

Manufacturer Of Weight Loss Drug Plans To Appeal

COQUILLE, OREGON (CBS News) – An Oregon jury has awarded $29.1 million in
damages to a 58-year-old bus driver and her son who said the diet drug
combination fen-phen damaged their hearts.

American Home Products Corp. said it plans to appeal Tuesday’s decision by a
Coos County jury, which said the drug, sold under the name Pondimin, caused
heart problems for Juanita Batson and Richard Wirt.

Fenfluramine, the “fen” in the drug combination, was withdrawn in September
1997 after a Mayo Clinic study linked it to potentially fatal heart valve
damage. The second drug in the combination, phentermine, was not linked to
any problems.

About 6 million people in the United States had been prescribed fen-phen by
the time the study was released.

American Home Products, based in Madison, N.J., faces more than 9,000
lawsuits involving Pondimin. The company also made Redux, a related drug.

Batson used the fen-phen diet drug for nine months to a year. Wirt, 40, who
works as a grocery store manager, took the drug for four months.

Their attorneys asked the jury to decide whether American Home Products knew
or should have know of the drug’s dangers and whether the two Bandon
residents were harmed financially from their injuries. The jury also was
asked to decide whether Dr. John Abbot was negligent in prescribing them the
drug.

Mark Spooner, a lawyer representing American Home Products, suggested the
plaintiffs’ health problems could be related to heredity or age.

Spooner called the trial a “lottery litigation wherein the plaintiffs were
absolutely healthy” until their attorneys “took them aside and told them they
weren’t.”

The jury’s decision came as a federal judge in Philadelphia decides whether
to approve American Home’s $3.75 billion plan to settle the majority of U.S.
lawsuits filed by former fen-phen users.

About 1 percent of those have opted out of a national settlement deal that
could make $3.75 billion available to users of Pondimin and Redux, As of May,
the case had about 282,000 claimants.

In a separate case, Debbie Lovett of Grand Saline, Texas, was awarded $23.3
million nearly a year ago by a jury. The case was settled for less than 10
percent of that amount during an appeal.

SOURCE: The Associated Press.

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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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6/22/2000 – Antidepressant Controversy

A revealing chat transcript with Dr. Joseph Glenmullen regarding
SSRI’s and suicide can now be found on the ABCNews.com.
Link follows the introduction.
————–

Antidepressant Controversy
Chat with Dr. Joseph Glenmullen

June 21
Dr. Joseph Glenmullen
Experts agree that drugs like Prozac and Zoloft (known medically
as Selective Serotonin Reuptake Inhibitors or SSRIs) are
effective, beneficial and crucial to patients who suffer severe
depression.

But is it possible that they may actually have a negative effect on
certain patients, possibly even driving some to suicide?
Dr. Joseph Glenmullen, author of Backlash: Overcoming the
Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with
Safe, Effective Alternatives joined us online in a chat immediately
following the broadcast.

For a transcript of this chat, please go to
http://abcnews.go.com/onair/2020/000621_prozac_chat.html

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6/21/2000 – A Dark Side to Prozac?

This story has been posted on ABC News.com, after tonight’s
20/20 Show and Dr. Glenmullen’s appearance on the ABC News
Chat.

A Dark Side to Prozac?
New Study Concludes Drugs Like Prozac May Induce Suicidal
Behavior

Selective Serotonin Reuptake Inhibitors (SSRIs) have helped
millions who suffer from depression. But, ask some medical
professionals, can they have potentially serious side effects?
(ABCNEWS.com)

By Rebecca Raphael

June 21 — In the winter of her freshman year at Harvard
University, Julie was prescribed Prozac to treat depression. But
instead of helping ease her symptoms, she says the medication
made her feel worse.

Almost immediately after taking the drug, Julie says she began
having trouble sleeping. Within a week, she says she felt
agitated and detached from the world around her.
“I couldn’t stand how I felt,” says Julie, who asked that her
last
name not be used. “It’s like I wanted to crawl out of my skin. It
was just terrible. I felt so terrible that I just thought, I
can’t live like
this.”

About a month after she started taking Prozac, Julie proceeded
to overdose on over-the-counter sleeping pills. “I couldn’t think
about my family; I couldn’t think about my friends,” she says.
“All I
could think was, I have to get out of this feeling.”
Julie says she had never before felt suicidal. “I knew that the
suicidal feelings had not been there before I started Prozac, I
remember that very distinctly,” she says. “I’m a very hopeful
person, despite having been depressed, and it’s a really
disconcerting thing to suddenly feel suicidal and not really be
able to explain why.”

After her suicide attempt, Julie was admitted to the psychiatric
ward of McLean Hospital in Massachusetts, where doctors notes
suggested that she had had a “paradoxical reaction to Prozac.”
Julie believes that the Prozac was the cause of her suicidal
feelings. According to a new study by Dr. David Healy, director of
the North Wales Department of Psychological Medicine in
Northern Ireland, Julie may not be alone in experiencing what is
called “akathisia,” an extreme form of agitation.

“I’m on record as saying that SSRI-type antidepressants like
Prozac and Zoloft can make people suicidal,” he says.
Healy’s study is one of the most recent that claims there are
potentially dangerous side effects for some patients on the class
of antidepressants called Selective Serotonin Reuptake
Inhibitors (SSRIs). It is now estimated that one out of eight
Americans has taken at least one of these drugs and the
suggestion of a connection between SSRIs and suicide is
raising controversy among doctors, patients and manufacturers
who are involved in the $6-billion-a-year market.

A Causal Link to Suicide?
In his most recent study, Healy took 20 healthy, non-depressed
volunteers and put them on Zoloft, an antidepressant that is
believed to work, like Prozac, by boosting serotonin levels in the
brain. Two of volunteers became suicidal. Healy believes it was
the Zoloft that caused akathisia, a combination that he says can
occur in some people during the first weeks of treatment.
But manufacturers of these drugs deny any causal relationship
between SSRIs and suicidal behavior. “The data that we’ve
reported is quite overwhelming that this drug is not associated
with increase in suicidality,” says Dr. Steven Paul, vice president
of clinical investigations at Eli Lilly, the maker of Prozac. “The
over 10,000 patients that have been on clinical trials where
people have looked at suicidality, suicidal ideation,” he adds,
“have shown without a doubt that these drugs do not increase
suicidal ideation or suicide potential. In fact, they do just the
opposite — they reduce it.”

Even critics like Healy agree that for some patients, these drugs
can be highly beneficial, which is why he continues to prescribe
SSRIs, including Prozac and Zoloft, to patients, though with
careful monitoring.

But, says Healy, based on his study, it is the rare cases that
concern him. “The conclusions are that these drugs can directly
cause people to commit suicide,” he says.
In a letter to 20/20, Pfizer, the maker of Zoloft, attacks
Healy’s
conclusions saying that there is “a vast body of valid medical and
scientific research” refuting his theory. Pfizer claims that there
was no reliable evidence that Healy’s subject’s were
“healthy” to
begin with, and calls the study’s conclusions “scientifically
bogus, false and misleading.”

Still, Healy does have his supporters. Dr. Joseph Glenmullen, a
clinical instructor of psychiatry at Harvard University Medical
School, who recently wrote Prozac Backlash, points to a 1990
study that says Prozac can induce “intense, violent suicidal
preoccupation.” In his book, he shares numerous anecdotes
about patients who experienced dramatic changes, including
anxiety, agitation, insomnia, suicide attempts and violence
toward others.

“We now have unequivocal evidence from a wide range of side
effects that these drugs are impairing the normal functioning of
the brain and that’s information doctors and the public need,”
Glenmullen tells 20/20’s Dr. Nancy Snyderman.

Critics of Glenmullen’s book point to a 1991 FDA study that
found there to be “No credible evidence of a causal link between
the use of antidepressant drugs, including Prozac, and
suicidality or violent behavior.” But unknown to many, transcripts
from the same FDA hearing show that three of nine panel
members expressed concerns about the data and were not
convinced.

Akathisia is only one of many potential neurological side effects.
Glenmullen says a significant number of people can experience
other problems, like fatigue, muscle spasms, sexual dysfunction
and withdrawal syndromes.

Despite these side effects, Glenmullen says, “For moderate to
severely depressed patients or with other conditions that they’re
used for, the drugs can be enormously helpful and you see
patients have clear-cut responses to them and really benefit
from them.” But, he says, they need to be aware of the potential
risks and monitored closely. Experts also warn that SSRIs
should not be discontinued without first consulting a doctor.
Glenmullen has petitioned the FDA to add a warning to the
labels of SSRIs alerting doctors and the public to akathisia,
suicidality and other side effects. “This is an urgent public health
concern given the tens of millions of people, including children,
being prescribed SSRIs,” he writes.

`They Need to Know’
After withdrawing from Harvard, Julie returned the following year
and graduated. Now married and in her final year of law school,
she says she has overcome her depression and put her life
back together.

Despite her belief and affirmation from some members of the
medical community that Prozac may have caused her suicidal
feelings, she says that for some people, antidepressants can be
a lifesaver. Though Julie ultimately would like to see
manufacturers include information about the side effects, she at
least hopes that her experience can serve as an opportunity to
increase public awareness.

“Prozac is a great drug,” she says. “People should take Prozac.
It can help people. But there are some people it’s not going to
help, and there are some people whose lives it could ruin. And
they need to know.”

For the actual story, please go to:

http://abcnews.go.com/onair/2020/2020_000621_prozac_feature
.html

648 total views, 3 views today

6/21/2000 – A Dark Side to Prozac?

This story has been posted on ABC News.com, after tonight’s
20/20 Show and Dr. Glenmullen’s appearance on the ABC News
Chat.

A Dark Side to Prozac?
New Study Concludes Drugs Like Prozac May Induce Suicidal
Behavior

Selective Serotonin Reuptake Inhibitors (SSRIs) have helped
millions who suffer from depression. But, ask some medical
professionals, can they have potentially serious side effects?
(ABCNEWS.com)

By Rebecca Raphael

June 21 — In the winter of her freshman year at Harvard
University, Julie was prescribed Prozac to treat depression. But
instead of helping ease her symptoms, she says the medication
made her feel worse.

Almost immediately after taking the drug, Julie says she began
having trouble sleeping. Within a week, she says she felt
agitated and detached from the world around her.
“I couldn’t stand how I felt,” says Julie, who asked that her
last
name not be used. “It’s like I wanted to crawl out of my skin. It
was just terrible. I felt so terrible that I just thought, I
can’t live like
this.”

About a month after she started taking Prozac, Julie proceeded
to overdose on over-the-counter sleeping pills. “I couldn’t think
about my family; I couldn’t think about my friends,” she says.
“All I
could think was, I have to get out of this feeling.”
Julie says she had never before felt suicidal. “I knew that the
suicidal feelings had not been there before I started Prozac, I
remember that very distinctly,” she says. “I’m a very hopeful
person, despite having been depressed, and it’s a really
disconcerting thing to suddenly feel suicidal and not really be
able to explain why.”

After her suicide attempt, Julie was admitted to the psychiatric
ward of McLean Hospital in Massachusetts, where doctors notes
suggested that she had had a “paradoxical reaction to Prozac.”
Julie believes that the Prozac was the cause of her suicidal
feelings. According to a new study by Dr. David Healy, director of
the North Wales Department of Psychological Medicine in
Northern Ireland, Julie may not be alone in experiencing what is
called “akathisia,” an extreme form of agitation.

“I’m on record as saying that SSRI-type antidepressants like
Prozac and Zoloft can make people suicidal,” he says.
Healy’s study is one of the most recent that claims there are
potentially dangerous side effects for some patients on the class
of antidepressants called Selective Serotonin Reuptake
Inhibitors (SSRIs). It is now estimated that one out of eight
Americans has taken at least one of these drugs and the
suggestion of a connection between SSRIs and suicide is
raising controversy among doctors, patients and manufacturers
who are involved in the $6-billion-a-year market.

A Causal Link to Suicide?
In his most recent study, Healy took 20 healthy, non-depressed
volunteers and put them on Zoloft, an antidepressant that is
believed to work, like Prozac, by boosting serotonin levels in the
brain. Two of volunteers became suicidal. Healy believes it was
the Zoloft that caused akathisia, a combination that he says can
occur in some people during the first weeks of treatment.
But manufacturers of these drugs deny any causal relationship
between SSRIs and suicidal behavior. “The data that we’ve
reported is quite overwhelming that this drug is not associated
with increase in suicidality,” says Dr. Steven Paul, vice president
of clinical investigations at Eli Lilly, the maker of Prozac. “The
over 10,000 patients that have been on clinical trials where
people have looked at suicidality, suicidal ideation,” he adds,
“have shown without a doubt that these drugs do not increase
suicidal ideation or suicide potential. In fact, they do just the
opposite — they reduce it.”

Even critics like Healy agree that for some patients, these drugs
can be highly beneficial, which is why he continues to prescribe
SSRIs, including Prozac and Zoloft, to patients, though with
careful monitoring.

But, says Healy, based on his study, it is the rare cases that
concern him. “The conclusions are that these drugs can directly
cause people to commit suicide,” he says.
In a letter to 20/20, Pfizer, the maker of Zoloft, attacks
Healy’s
conclusions saying that there is “a vast body of valid medical and
scientific research” refuting his theory. Pfizer claims that there
was no reliable evidence that Healy’s subject’s were
“healthy” to
begin with, and calls the study’s conclusions “scientifically
bogus, false and misleading.”

Still, Healy does have his supporters. Dr. Joseph Glenmullen, a
clinical instructor of psychiatry at Harvard University Medical
School, who recently wrote Prozac Backlash, points to a 1990
study that says Prozac can induce “intense, violent suicidal
preoccupation.” In his book, he shares numerous anecdotes
about patients who experienced dramatic changes, including
anxiety, agitation, insomnia, suicide attempts and violence
toward others.

“We now have unequivocal evidence from a wide range of side
effects that these drugs are impairing the normal functioning of
the brain and that’s information doctors and the public need,”
Glenmullen tells 20/20’s Dr. Nancy Snyderman.

Critics of Glenmullen’s book point to a 1991 FDA study that
found there to be “No credible evidence of a causal link between
the use of antidepressant drugs, including Prozac, and
suicidality or violent behavior.” But unknown to many, transcripts
from the same FDA hearing show that three of nine panel
members expressed concerns about the data and were not
convinced.

Akathisia is only one of many potential neurological side effects.
Glenmullen says a significant number of people can experience
other problems, like fatigue, muscle spasms, sexual dysfunction
and withdrawal syndromes.

Despite these side effects, Glenmullen says, “For moderate to
severely depressed patients or with other conditions that they’re
used for, the drugs can be enormously helpful and you see
patients have clear-cut responses to them and really benefit
from them.” But, he says, they need to be aware of the potential
risks and monitored closely. Experts also warn that SSRIs
should not be discontinued without first consulting a doctor.
Glenmullen has petitioned the FDA to add a warning to the
labels of SSRIs alerting doctors and the public to akathisia,
suicidality and other side effects. “This is an urgent public health
concern given the tens of millions of people, including children,
being prescribed SSRIs,” he writes.

`They Need to Know’
After withdrawing from Harvard, Julie returned the following year
and graduated. Now married and in her final year of law school,
she says she has overcome her depression and put her life
back together.

Despite her belief and affirmation from some members of the
medical community that Prozac may have caused her suicidal
feelings, she says that for some people, antidepressants can be
a lifesaver. Though Julie ultimately would like to see
manufacturers include information about the side effects, she at
least hopes that her experience can serve as an opportunity to
increase public awareness.

“Prozac is a great drug,” she says. “People should take Prozac.
It can help people. But there are some people it’s not going to
help, and there are some people whose lives it could ruin. And
they need to know.”

For the actual story, please go to:

http://abcnews.go.com/onair/2020/2020_000621_prozac_feature
.html

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6/20/2000 – Wednesday night 20/20

This Wednesday evening 20/20 will air a show on SSRI side effects. Air time
is 8:00 PM Eastern Daylight Time. Check local stations for air time and
channel in your local area. Producers for the show have interviewed some of
the members of our group who have suffered serious damage as a result of the
SSRIs. We wish to thank them for their courage in sharing their personal
tragedies in an effort to warn others of the dangers of these drugs.

Also on Wednesday evening I (Ann Blake-Tracy) will be a guest on the Jeff Rense
national radio show. The show will air at 8:00 PM Pacific Time. If he is not
on in your local area I believe you can listen live on the internet at his
site – www.sightings.com. The show I did with Jeff last month is archived on
that site as well if you would like to listen to it.

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

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