12/02/2000 – Upcoming shows of interest

Judy Coburn, from here in Utah, whose husband killed himself on Paxil, and
whose daugther Amy (14) attempted suicide on Paxil and was featured on the
cover of US News and World Report earlier this year, will be on Montel show
next week. It will air Wednesday at 10:00 AM MST. Check local listings to
find air time in your local area.

And, although I do shows regularly, I have not generally let you know about
when and where those shows will air. I will attempt to keep you better
informed. This week on Tuesday evening 8:00 PM Central Time I will be doing a
radio show with Alex Merkley. If you cannot find him in your local area, you
can find him on the net at www.broadcasttalk.com. There will be another one
this week out of Detroit, but I do not yet have the date and time for that
show.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

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10/14/2000 – New Suicide Warning in Great Britain

Here’s an email that Circare, a health rights organization, has
sent to the White House recently. Note the new warning that is
eliciting controversy in Great Britain:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Also attached are two relevant articles written by Sarah Boseley,
Health correspondent for the Guardian.

Mark

From: Vera Hassner Sharav, President
CIRCARE: Citizens for Responsible Care & Research,
A Human Rights Organization
Tel. 212-595-8974 FAX: 212-595-9086
veracare@…

In response to increasing public concern over suicides among
people taking Prozac and other SSRI anti-depressants, the
British Medicines Control Agency (MCA) (which is the equivalent
to the U.S. Food and Drug Administration) now requires the
manufacturers of Prozac and the other anti-depressants to add
the following warning to physicians and patients:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Why has the FDA failed to issue similar warnings to protect the
American public?

In the U.S. these drugs, though associated with an array of
severe adverse reactions in some patients, are widely and
haphazardly prescribed, not only for adults, but for children–even
toddlers and infants. Contrary to industry claims that these
drugs are safe– based on short-term (usually 6 week) clinical
trials before they were approved by the FDA– their long-term
effects have not been studied, nor is it known whether they are
safe for children.

According to FDA compiled data, in 1994 Prozac was prescribed
349,000 times in pediatric patients under 16 years; Zoloft was
prescribed 248,000 times. Furthermore, PROZAC was
prescribed 3,000 times for infants under one year old ! [See,
Psychiatric Times, March 1998, p. 69]

Instead of protecting the public by warning physicians and
patients about the risks associated with the drugs, the FDA is
protecting the profit-margins of drug manufacturers.

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40677
31,00.html

THE GUARDIAN

Prozac warning comes under fire
Position on suicidal tendencies is ‘dangerously misleading’

Sarah Boseley, health correspondent Guardian
Monday September 25, 2000

A new warning issued by the Medicines Control Agency, stating
that people may feel suicidal in the first few weeks of taking
Prozac and similar antidepressants, is dangerously misleading
and could lead to more deaths, according to a leading authority
on the drugs.

David Healy, director of the North Wales Department of
Psychological Medicine in Bangor, has told the MCA that among
those who are not severely depressed – who are the majority of
those now being given antidepressants – it is the drugs, and not
the illness, that make people want to kill themselves. The
warning will lead to doctors keeping their patients on the drugs
in the assumption that the medication will eventually make them
better, when they need to be taken off.
The new warning is the MCA’s response to increasing public
concern over suicides among people on drugs in the Prozac
class. The agency has instructed manufacturers to include it in
the drug datasheets for doctors and information leaflets for
patients. It states that suicidal thoughts may occur or increase in
the early weeks of treatment, and may continue for some time
until the drug takes effect.

But Dr Healy, the UK’s leading historian of antidepressant
medication, believes it is the drugs themselves that are causing
some people to feel like killing themselves – not depression. And
if, as the patient leaflet warning states, there is an increase in
suicidal thoughts, he says, it can only be due to an effect of the
drug. But increasingly the SSRIs (selective serotonin reuptake
inhibitors) are being given to adults and children who are not
depressed, but merely anxious and who should therefore have
no suicidal feelings.

Dr Healy has written to Keith Jones, director of the MCA, pointing
to two studies – one of them carried out by his own team –
showing that healthy volunteers with no history of depression
have become dangerously suicidal after taking one of the SSRI
class of drugs for a couple of weeks. “This will lead to deaths,”
he told Dr Jones in a letter. “Your advice will lead to a situation
where patients who worsen on treatment will be kept on that
treatment by their GPs in the belief that it is only in this way that
the suicide risk can ultimately be lowered. This is mistaken
advice that is going to increase the rate at which patients move
from emergent suicidality[beginning to feel suicidal] to suicidal
acts.”

Earlier this year, Dr Healy published a study of the effects of one
of the SSRIs, sertraline, on 20 healthy volunteers. Two of them
became suicidal.

One told researchers that she had become obsessed with the
idea of throwing herself under a car or a train, while the other
fantasized about hanging herself from a beam in the bedroom
ceiling.

The MCA also has in its possession a much earlier study of the
effects of sertraline on healthy volunteers. Dr Jones
acknowledged in a letter to Dr Healy that this study similarly
shows a “pattern of severe adverse side-effects and drop outs.”

He goes on to remark that the pattern “seen in this small study
was not replicated in any other study involving sertraline”. Yet it
has been – in the Healy study published earlier this year in
Primary Care Psychiatry and revealed in the Guardian in May.

These two studies, says Dr Healy, would be conclusive enough
for the manufacturers to get a license from the MCA to market
sertraline as a drug to cause agitation – if anybody had a use for
such a medicine. Yet the MCA will not accept that this, and other
SSRIs, can cause people to feel suicidal as a side-effect. The
MCA’s decision to require a new warning with the SSRIs was
taken after a review of the data by the Committee on the Safety of
Medicines.

The MCA said in a statement that the CSM had considered both
the healthy volunteer studies as part of the overall risk
assessment. “The CSM concluded that reports of suicidal
thoughts in healthy volunteers were difficult to explain, however,
other data were reassuring. For this reason, the issue will be
kept under review and further advice will be sought as
necessary.”

Guardian Unlimited © Guardian Newspapers Limited 2000

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40208
31,00.html

The GUARDIAN

Happy drug Prozac can bring on impulse to suicide, study says
As best-selling pill is prescribed by GPs for ever more sufferers
from mild depression, research brings disturbing evidence to
light

Sarah Boseley, health correspondent
Guardian

Monday May 22, 2000

Alarming evidence from a new British study shows that the
Prozac class of antidepressants can make healthy men, women
and children with no history of depression feel suicidal.

The research undermines the claims of Eli Lilly, makers of
Prozac, that people who kill themselves while on the tablets do
so because of their depression, and that the disease, not the
drug, is to blame for their suicide. Its findings are particularly
worrying because of the increasing numbers of people,
including children, who are being given the drugs by their GP for
mild depression, and who are not seriously clinically ill.

Prozac, the wonder pill of the 1980s and 1990s, became the
biggest drug company blockbuster of all time, prescribed to
more than 38m people around the world. It became a metaphor
for late 20th century life and a cult in its own right, enshrined in
a
book called Prozac Nation.

What began as a medicine for the clinically depressed has been
transformed by use and demand into a pill for minor ills. But
while the happy drug works for many people, in a significant
number it can take them to the edge of despair. The study,
conducted by David Healy, director of the North Wales
Department of Psychological Medicine, reveals the real dangers
for some of the SSRIs (selective serotonin reuptake inhibitors),
as Prozac and its imitators are called.

Nightmare

It found that two out of 20 healthy volunteers on an
antidepressant in the Prozac class called Lustral (or Zoloft in the
USA) became dangerously suicidal, compared with none of
them when they were put on an antidepressant of a different
class called reboxetine.

One 30-year-old woman who took part had a nightmare about
having her throat slit after one week and by the end of a fortnight,
was suicidal. “She felt hopeless and alone. It seemed that all
she could do was to follow a thought that had been planted in
her brain from 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, which she was going to throw herself under. She didn’t
think of her partner or child,” says the study, published in the
journal Primary Care Psychiatry. Later she completed a diary
entry, describing herself as jumpy, anxious and suspicious. “Her
mind was racing and spiraling out of control. Then it went blank
except for the clear thought that she must kill herself violently by
throwing herself beneath a car or a train.”

Dr Healy says the results of the research should be a warning to
GPs prescribing any SSRIs. “They may not all be equally the
same,” he told the Guardian. “But the risk holds for the whole of
the group.

Generally the findings would indicate that women and children
and those who are least ill may be most at risk.” All the drugs
have been licensed as both safe and efficacious on the basis of
data from clinical trials. But Dr Healy believes that there are
serious problems with the reporting of side-effects in these
trials, and that this has allowed drugs to be handed out to
millions around the globe without their true risks being
understood.

Volunteers taking part in the early trials were never asked
whether they experienced any suicidal feelings or the restless
agitation which can be the precursor of a suicide attempt. If
patients in later trials said they felt suicidal, it was recorded as
part of their depression.

Dr Healey has written to the Medicines Control Agency, which
licenses medicines in the UK, expressing his concern and
pointing out that he believes patients who today become suicidal
on SSRIs are in a state of “legal jeopardy”.

Firms are using data from trials that were not designed to look at
suicidality to prove that their drugs could not have caused it. Until
the system for reporting side-effects is changed, he questions
whether anybody should take part in clinical trials.

The new study’s findings have emerged at a time of acute
embarrassment for Eli Lilly. Its patent on Prozac (fluoxetine), is
soon to expire, but it recently bought the license for a second
version of the drug, called R-fluoxetine. The patent for the new
drug, it has just been revealed in the US, states that R-fluoxetine
is improvement on Prozac specifically as it is less likely to cause
“suicidal thoughts and self-mutilation”.

Eli Lilly argues that the patent was filed by the American scientist
Martin Teicher and the company Sepracor which devised the
new drug. Mr. Teicher, in 1990, was the first to warn that patients
on Prozac were becoming suicidal, but Eli Lilly has always
dismissed his study on the basis that those patients were
suffering chronic depression.

Dr Healy, the UK’s leading historian of antidepressant
medication who has given evidence against Lilly in litigation in
the US, has frequently taken issue with the major study
commissioned by the company to persuade the US Food and
Drugs Administration that Prozac carried no suicide risk. Dr
Healy has argued there has never been a prospective study and
that the retrospective 1991 Beasley study, as it is known,
included only a small selection of the trials that had taken place
on Prozac.

An internal memo released by Eli Lilly during recent litigation
appears to support Healy’s argument. In one of a series of
memos, dated August 27, 1990, a UK-based clinician tells Eli
Lilly management in Indianapolis that critics will be suspicious
of the fact that not all the trials were included and concludes that
it gives “the impression that the question of whether fluoxetine
provokes suicidal thoughts or not has not been properly
considered.”

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10/09/2000 – Congressman attributes son’s suicide to Accutane

msnbc.com

Lawmaker tells of acne drug’s risk

Rep. Bart Stupak.

NBC’s Dr. Bob Arnot discusses the possible health risks of Accutane and
alternative treatments for severe cases of acne.

Congressman attributes
son’s suicide to Accutane

MSNBC STAFF AND WIRE REPORTS

TRAVERSE CITY, Mich., Oct. 5. A Michigan congressman whose
17-year-old son committed suicide earlier this year went public Thursday with
criticism of the Food and Drug Administration, charging on NBC’s Today
show that the agency had failed to warn consumers that the popular acne
medicine Accutane may cause depression.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that. REP. BART STUPAK

BART STUPAK JR., known as B.J., shot himself in the head with his
father’s gun in the early hours of May 14. Stupak, a popular football player,
killed himself after a prom-night party.

His father, Rep. Bart Stupak, a four-term Democrat from Menominee,
said Thursday that he blames Accutane, a powerful acne drug B.J. had taken
for six months prior to his death. We knew our son, we loved our son, he
said.

The congressman and his wife, Laurie, said they had considered every
possible explanation for B.J.’s suicide and the only thing we can find is
Accutane.

FDA ADVISORY

In 1998, the Food and Drug Administration advised doctors who
prescribe Accutane to watch their patients for signs of depression.
Afterward, the company notified doctors that the drug may cause depression,
psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.

But Stupak said the FDA had done a poor job spreading the word. B.J.’s
medication package included no warning and the doctor didn’t tell the parents
about the link to depression, his father said.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that, Stupak said.

Hoffmann-La Roche, which manufactures Accutane, contends no
link has been proven between the drug and depression or suicide. In 1998, the
company argued that more than 4 million Americans have taken Accutane since
it was approved in 1982, and the possible side effect is very rare. It said
teen-agers, prime acne sufferers, often suffer depression, and hormones
involved with acne also may contribute to depression.

B.J.’s death stunned family and friends. In the Today interview,
his parents said he was a happy young man with a bright future.

COMPLETELY OUT OF CHARACTER

This is contrary to everything he lived for, everything he thought,
everything he wanted in life … completely out of character for him, Stupak
said. He would not do something like this.

B.J. left no note and the autopsy showed no drugs in his system,
although he apparently had taken a couple of drinks.
Advertisement

The only suggestion of odd behavior came the night before his death.
During a party following his junior prom, B.J. began reading the Bible and
said he wasn’t going to college because of his grades, and that his parents
probably hated him for that, according to an account on the Today program.
The Stupaks said there was no reason for him to think such a thing.

An FDA science advisory panel last month suggested requiring
Hoffman-LaRoche to give patients information about potential risks, agency
drug chief Janet Woodcock said.

INSUFFICIENT DATA

But Woodcock said there still was insufficient data to establish a
definite connection between Accutane and depression or suicide.

It’s really hard to nail this down, she said in a telephone
interview Wednesday. The bottom line is there is evidence against there
being a link and evidence for being a link.

During the advisory panel meeting, FDA staffers presented evidence
that some people had become depressed when taking the drug and had gotten
over their depression after stopping use of the drug, Woodcock said.

But experts for Hoffman-LaRoche countered with evidence suggesting no
link, she said. The committee recommended further study.

The Associated Press contributed to this report.

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Suicidal on Prozac.

“…an incredible journey into another world.”

 

I am another in a long line of Prozac victims. For most of my life I’ve suffered from bouts of depression. After teaching in the public schools for nearly twenty years, I requested Prozac to help with my increasing depression. The following months began an incredible journey into another world.

At first I noticed that my self-confidence was growing. Even in my dreams (which were often fearful and involved my being in overwhelming situations) I began to gain confidence. I remember that in one dream instead of running away in fear, I stood my ground and fought my aggressor. This was an unheard of event! As one who has been given the gift of music but a paralyzing fear of being imperfect thrown in, I began to have the confidence to perform before others and finally get some affirmation.

As you might guess, if the story ended there, all would have been well. However, eventually I began to drink heavily, become very aggressive , and start to behave in ways that were also new to me. I struggled in other areas too personal to mention here in my personal life. Eventually, I saw clearly that my life was a curse to all concerned. One hears that the person who attempts suicide must be a real coward who cares only about himself. On the contrary, I knew that my continued existence was a threat to everyone I cared about. The most loving thing I could do was to end my life before I took others down with me.

I wrote the usual note saying good-by and tried to overdose on everything I could find. I swallowed all the Prozac I had, Benadryl, ….whatever I could find. I went to bed knowing that I was doing the right thing. When I survived and was brought to in the hospital, I was furious at those who had saved me. Learning that my survival was a miracle was not met by me with rejoicing. It took a while for my anger to subside.

At the ward they took me off all medication and watched me carefully. As days passed, it all began to look like a bad dream and I couldn’t imagine why I had attempted suicide. I swore to all it would never happen again. I was eventually dismissed, sent home, and again prescribed an antidepressant. This one was Effexor. Within one year the whole series of events repeated itself and I attempted suicide again…and failed. This attempt was strange. I had had a wonderful day but had ended it with a disagreement with my son. Without so much of a second thought, I was swallowing pills to kill myself!

Obviously, after my survival the psychiatrists still didn’t consider the fact that although I had been depressed most of my life I had never attempted suicide until I was put on these new antidepressants. I went back on Prozac this time. However, I was beginning to get a feeling on my own that the medication might be the cause. However, to stop and face depression with nothing was frightening. I decided to cut my dosage from 20 mg to 10 mg a day. This small drop seemed to help immensely. I just never told the doctors. Still with even 10 mg I could become furious easily. I just didn’t totally lose it.

Then I discovered you on the internet and found out about all the other people like me. Last week I stopped the Prozac and began taking ST. John’s Wort instead. I don’t know what the future holds. Perhaps, I’ll continue with the herbs. Maybe not. I don’t like taking anything, but from what I’ve learned on the web, SJW doesn’t affect a person like Prozac. I guess I will eventually find out, won’t I?

Well, that is my very condensed story. I have decided to order your book if for no other reason than to reinforce my decision not to return to Prozac.

Thank you for coming out like you have against the drug companies and helping those of us who have been so misled. I hope my story ends happily.

D.S.
Wolf444@webtv.net

Years 2000 and Prior

This is Survivor Story number 84.
Total number of stories in current database is 96

309 total views, 1 views today

Suicide after One Month on Celexa and lorazipam

“I do wonder just how often suicide, attempted suicides and murders are committed by people who are taking SSRI drugs.”

 

My son, 31 years of age, was prescribed Celexa 20mg/day and lorazipam .5mg as needed, July 22, 1999, on first visit without any form of physical examination and with only a short interview by a case worker and psychiatrist. He was seen on August 4, at which time the doctor said he was better. On August 21, 1999, he committed suicide. I cannot scientifically prove Celexa was the cause. I only know what others and myself know about him and his behavior. We are convinced the medication definitely increased his symptoms of frequent mood swings, anxiety, fear, inability to sleep, panic, anger, inability to concentrate.

Because of my son’s death (suicide) while taking Celexa, I have become aware of the habit of doctors prescribing selective serotonin reuptake inhibitors TOO OFTEN, and in my opinion, WITHOUT SUFFICIENT REGARD TO THE DANGEROUS SIDE EFFECTS AND/OR OTHER HEALTH CONDITIONS WHICH COULD BE THE CAUSE OF THE DEPRESSION. I do wonder just how often suicide, attempted suicides and murders are committed by people who are taking SSRI drugs.

On 9-17-99, I phoned Adverse Drug Reactions Medical Inquiries and was transferred to New Jersey Drug Safety. I spoke with Christine Casilana (uncertain of correct spelling), of Forest Pharmaceuticals. She took all pertinent information and assured me the report would be sent to the FDA. I specifically asked about the statement in the package insert that reads, “frequent adverse events are those occurring on one or more occasions in at least 1/100 patients”. Under “Psychiatric Disorders” those listed as frequent among others noted are: “impaired concentration, depression, aggravated depression, suicide attempt”. Christine explained that frequent – the 1/100 figure – meant that AT LEAST ONE (but the actual number could be higher than just one) out of 100 made a suicide attempt on Celexa.

One is a large percent when indicating DEATH, especially if it is YOUR loved one. I don’t mean to sound angry, I just want someone to pay attention. It is hard to believe this drug is given out so readily. The selective serotonin reuptake inhibitors are prescribed far to freely and without sufficient supervision of the patient AND with some doctors, without adequate examination.

 

Years 2000 and Prior

This is Survivor Story number 43.
Total number of stories in current database is 96

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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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6/13/2000 – Quandary Over Prozac – Boston Globe Editorial

http://search.boston.com/globe.vts

A BOSTON GLOBE EDITORIAL

The Prozac Question

Eli Lilly, manufacturer of the highly successful antidepressant drug Prozac,
wants to have it both ways. While it has always insisted that the drug does
not cause even a tiny percentage of its users to contemplate suicide, it also
wants to sell an updated version of Prozac with a patent which states
specifically that one of its advantages over the original is that it is less
likely to cause suicidal thoughts.

Now the firm has been caught in this contradiction by a Houston lawyer whose
clients unsuccessfully sued Lilly after their father killed his wife and then
himself while on the drug. By the time of the trial last year, Lilly had
bought rights to the new patent, boasting of its superiority over Lilly’s
original Prozac, whose patents expire in 2004.

The lawyer says his clients would have gotten a fairer trial if Lilly had
come forward with that language, and he is now asking a federal court for a
new trial. His clients deserve that chance, and the Food and Drug
Administration should ask Lilly why, in light of the language in its new
patent, it is not warning current Prozac users about suicidal thoughts.

Even if it had been aware of the new patent language, the jury might still
have exonerated the drug manufacturer. Prozac is hailed by many health
professionals for treating often debilitating depression and actually
preventing suicides. And while a small percentage of Prozac users have
committed suicide, it is not easy to prove that it was the drug and not the
underlying illness that was the cause.

Lilly, for its part, notes that a separate company developed the new version
of Prozac and wrote the patent language for it before Lilly acquired the
patent. And Lilly says ”not all of the `side effects’ listed in the patent
are scientifically demonstrated facts.” But why should a patent have been
issued for a new version of Prozac if it does not reduce side effects like
suicidal thoughts?

The FDA should reopen the question of whether the patent language on the new
Prozac is not a warning that users and prescribers of the original Prozac
should have been receiving all along. The patent’s message should also be
conveyed to a jury in a second trial of the Houston lawyer’s case.

This story ran on page A26 of the Boston Globe on 6/13/2000.
© Copyright 2000 Globe Newspaper Company.

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5/24/2000 – Antidepressants-Suicide Link

This appears at

http://abcnews.go.com/sections/living/DailyNews/antidepressant
s0515.html
——

Antidepressants-Suicide Link
Harvard Psychiatrist: Studies Needed

The Associated Press
B O S T O N, May 15 — Dr. Jonathan O. Cole, a Harvard
psychiatrist who has suggested a link between antidepressants
like Prozac and suicide, says drug manufacturers and the
federal government haven’t adequately investigated the problem.

In the decade since Cole and Harvard colleagues first reported
on early cases of extreme agitation among people taking Prozac
and related antidepressants, use of these drugs — called
selective serotonin reuptake inhibitors, or SSRIs — has reached
84 million prescriptions a year, according to The Boston Globe.

No one has done the large-scale studies necessary to pin down
the frequency of SSRI-related suicides, Cole said in a document
filed in U.S. District Court in Kansas City in support of a lawsuit
brought by the family of Matthew Miller, a Missouri teenager.

Miller, 13, had been taking Zoloft, a chemical cousin of Prozac,
for only a week when he hanged himself in his bedroom closet
July 28, 1997.

Adequate Evidence of a Link
Dr. David Healy, a British researcher who is the family’s chief
expert witness, said there is adequate evidence that Zoloft
caused the youth to commit suicide.
However lawyers for Pfizer Inc., maker of Zoloft, said there is no
credible scientific evidence that Zoloft and related drugs
precipitate suicide.

Dr. Anthony J. Rothschild of the University of Massachusetts
Medical School said he thinks drug manufacturers, specifically
Eli Lilly and Co., Prozac’s maker and the FDA have adequately
addressed their critics’ concerns.

“The thing that disturbs me” about current SSRI critics,
Rothschild said, “is the tone that suggests there’s almost a
conspiracy to cover up information, and not do the right studies.”

Copyright 2000 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten or
redistributed.

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5/24/2000 – Questions Persist Concerning Prozac’s Role in Suicide Risk

The former US Surgeon General, Dr. C. Everett Koop has joined
in the current concern over SSRI medications and suicide, and
posts this on his site, drkoop.com.
————-

Questions Persist Concerning Prozac’s Role in Suicide Risk

May 11, 2000

Lee Hickling
drkoop.com Health News

The question of whether Prozac, the most-prescribed
antidepressant, can make some patients more likely to commit
suicide just won’t go away, despite repeated and categorical
rebuttals by the drug’s manufacturer, Eli Lilly and Co.

Based on his experience as a suicide counselor and
investigator, Dr. Ronald W. Maris, director of the Center for the
Study of Suicide at the University of South Carolina, is firmly
convinced that a risk exists.

Research done in Wales by Dr. David Healy, director of the
University of Wales’ North Wales Department of Psychological
Medicine, appears to show a cause-and-effect relationship
between Zoloft (sertraline) and the emergence of suicidal
thinking in a group of physically and mentally healthy adult
volunteers. Zoloft, like Prozac (fluoxetine), is a selective
serotonin
uptake inhibitor (SSRI). Healy has completed a similar study with
Prozac, but its results have not yet been published.

A spokesman for Lilly said today, “There is no scientific evidence
to establish a link between Prozac and suicide.” He cited a l991
study by a Food and Drug Administration advisory panel, which
unanimously agreed that there was “no credible evidence of a
causal link between the use of antidepressants, including
Prozac, and violent behavior.”

Even the drug’s critics agree that the effect, which the company
says does not exist, occurs in only a small number of cases —
fewer than 1 percent. Maris said that although the incidence is
very low, when it happens it is such a serious matter that doctors
should be very careful in prescribing Prozac, and extremely
watchful when they do.

Maris said the danger is greatest during the first week or two of
Prozac use, when some patients who were already at risk for
suicide have a rare reaction that makes them feel energized and
more ready to act on their self-destructive impulses. There is
another dangerous time later, when a patient, who had been
virtually immobilized by deep depression, still entertains suicidal
thoughts. At this time, the drug has moderated their depression
enough to make them able to carry out these thoughts.

Healy’s study showed a similar pattern, and left him convinced
that a direct link exists between SSRIs and the emergence of
suicidal thinking in people who had never had such thoughts. He
is not the first medical researcher to suspect such a reaction. Dr.
Martin Teicher of Harvard Medical School reported in 1990 that
he and his colleagues had observed suicidal thoughts emerging
in six patients who were taking Prozac. Other researchers and
clinicians began reporting that they saw it too.

Serotonin is a relatively simple chemical that is vital to the
brain’s
regulation of a great many body functions — sleep, appetite, and
even more basic activities such as muscular activity, breathing
and blood circulation. Abnormal serotonin levels have been
blamed for a large number of mental and physical problems,
including depression, obsessive-compulsive disorder and panic
disorder.

Prozac and the other SSRIs have been prescribed for all those
problems and more, and have produced dramatic improvement
in a majority of cases. “Prozac is a valuable drug,” Maris said.
“For every horror story, there are thousands of persons who say
their lives were saved by it.”

But he said, doctors need to be much more careful about
prescribing it. They should investigate the patient’s history,
particularly the psychological history, to see if there have been
any indications of suicidal thought or other instability, and then
should monitor each patient very carefully. He said that is not
always done.

Because any physician can prescribe Prozac, and general
practitioners, primary care doctors and specialists in other areas
might not be as alert for danger signs as a psychiatrist might be,
Maris said Lilly should have warned doctors about Prozac’s
dangers.

The company did not do that. According to a Boston Globe story
earlier this week, internal Lilly documents show that in 1990,
corporate executives pressured Lilly scientists to alter records
on physicians’ experiences with Prozac. They changed mentions
of suicide attempts to “overdose” and of suicidal thoughts to
“depression.”

Some of Lilly’s own studies were cited by the German equivalent
of the Food and Drug Administration, delaying Prozac’s approval
there. They showed that previously nonsuicidal patients who
took the drug had five times the rate of suicide or suicide
attempts as patients on older antidepressants. When the drug
was approved for sale in Germany, a warning was required on
the label. The label warned that the drug’s use carried a risk of
suicide, and recommended that sedatives be given along with it.

The Globe said figures in Lilly internal documents showed that
in early clinical trials, 1 in 100 previously nonsuicidal patients
who took Prozac became anxious and agitated, and either
attempted or committed suicide during the studies.

Some of the previously unknown information that Eli Lilly
possessed about the drug has come to light during civil trials in
which the company was sued for wrongful deaths following
suicides, or during criminal trials in which defense lawyers
argued that Prozac caused a defendant’s violent and homicidal
behavior.

Maris has been an expert witness in a number of trials, including
one in Hawaii last year in which Healy also testified. William D.
Forsyth Sr., a retired businessman, stabbed his wife 17 times
and then stabbed himself to death. He had been taking Prozac
for 10 days. His family brought a wrongful death suit against Lilly,
claiming that the company knew Prozac could make some
people violent or suicidal, and failed to notify physicians about it.

The plaintiffs wanted $1 million in damages and the addition of a
warning statement to the Prozac label. A jury found for the
defendant, Lilly. So far, Lilly has won every Prozac-related civil
suit against it, more than 100 and possibly 200. The number is
difficult to verify because most did not go to trial. Some — Lilly
says only a few — were settled out of court to avoid the expense
of defending them.

In criminal cases up to now, prosecutors, frequently with the help
of expert witnesses suggested by the company, have been able
to obtain convictions despite defense claims that the drug had
turned a previously stable and nonviolent person into a
murderer.

The most often-prescribed antidepression drug in the world,
Prozac has been Lilly’s major moneymaker ever since it was
introduced in 1988. Its sales, however, have been falling, for
which the company’s annual report blames “changes in
wholesaler purchasing patterns and intense competition.” Four
years ago, it accounted for more than one-third of Lilly’s total
sales. Last year it represented just over one-quarter.

The company’s patents on Prozac will start to expire next year. A
patent has been granted for its successor, R-fluoxetine, which
Lilly will make and market. In the patent application, which the
Boston Globe obtained, the company said the new drug will
decrease such side effects such as headaches, anxiety and
insomnia, and also “inner restlessness (akathisia), suicidal
thoughts and self-mutilation.”

Akathisia, an overwhelming physical and mental restlessness,
has been cited by physicians and researchers as a frequent
side effect in the cases in which they believe Prozac is causing
violent, impulsive and sometimes suicidal behavior. Teicher,
who pioneered research on the question, observed it in a
number of Prozac patients who attempted or committed suicide.

Teicher is one of the developers of the “new Prozac,”
R-fluoxetine, and a co-owner of the patent.

THIS POSTING CAN BE FOUND AT
http://www.drkoop.com/news/stories/may/prozac.html

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5/23/2000 Accutane May Be Linked To Depression, Suicide

In case you missed this I wanted to send this out again. I feel it is very
important to know. There are too many children on this type of medication and
little knowledge of these serious side effects to this drug. How many
children are ending up on antidepressants as a result of their acne meds?

Ann Blake-Tracy
_______________________________

http://www.pslgroup.com/dg/5d8e2.htm

FDA Reports Accutane May Be Linked To Depression, Suicide

WASHINGTON, MD — February 26, 1998 — The United States Food and Drug
Administration is advising consumers and health care providers of new
safety information regarding the prescription anti-acne drug Accutane
(isotretinoin) and isolated reports of depression, psychosis and rarely
suicidal thoughts and actions.

Accutane was approved in 1982 to treat only a very special type of acne —
severe nodular acne that has not responded to other therapies.

Although the Accutane label already included information regarding
depression as a possible adverse reaction, the agency felt health care
providers and others needed additional information as a result of adverse
event reports the agency has received.

FDA and the drug manufacturer are strengthening this label warning, even
though it is difficult to identify the exact cause of these problems. Such
problems could already be more common among the patient populations likely
to be on the drug.

However, because some patients who reported depression also reported that
the depression subsided when they stopped taking the drug and came back
when they resumed taking it, the agency and the manufacturer felt the
strengthened labelling was warranted as a precautionary measure.

Given the complex nature of depression and suicidal conditions, the new
label information will advise health care providers that merely
discontinuing the drug may be insufficient to remedy these adverse events
and that further evaluation may be needed.

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