Strattera Deaths (German TV Request) False Reports from Eli Lilly

Wed Nov 12, 2008

We have received a request from a German TV crew who is doing a special on Lilly’s newer ADHD medication, Stratera. These investigative reporters from Germany are doing a 45 minute piece and looking for experiences of tragedy /suicide or severe adverse reactions in children treated for ADHD with this drug. I know we have had reports, but I do not keep close track anymore of which drug is involved after so many cases because all these drugs work basically the same way. An antidepressant is an antidepressant no matter what you callmit or what you prescribe it for or how you explain its supposed uniqueness. So if you or someone you know has been through a Strattera-induced nightmareand would be willing to help get some exposure of this in the press, please get in touch with me so that I can put you in touch the reporters.

O nce you read the following article on Strattera deaths you will see how very important it is to get information about this drug out to the public –

especially throughout the UK and Europe. What is going on here IS CRIMINAL!!
And here is just one example out of the article below that is full of data on how
the government agency in the UK who oversees these drugs is ignoring
critical information – even fatalities, and doing NOTHING but making excuses
for their own behavior:

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing “œpsychomotor hyperactivity. Lilly called
this an exacerbation of the “œunderlying ADHD”. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done not even from the manufacturer.

Do read the rest of the information because it is clearly eye opening!! This
newer ADHD drug, Strattera, which is really an SSRI antidepressant, is
getting away with murder right under everyone’s noses. So definitely if you
know someone who is willing to talk to this news crew about their experience with
this drug, please do let me know ASAP.

Thank you,

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_
medicines_agency_refuses_to_act.htm#_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
dicines_agency_refuses_to_act.htm#
)

October 20, 2008
_Print this article_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
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Strattera adverse effects: UK Medicines Agency refuses to act
By Sepp Hasslberger

Categories
_Pharma_ (http://www.newmediaexplorer.org/sepp/pharma.htm)

Janne Larsson, an investigator and reporter in Sweden, has obtained
information about adverse event reports on Eli Lilly’s ADHD drug Strattera,
using the Swedish freedom of information laws. The data, coming from both the FDA’s
adverse reaction database and from reports to the UK’s Medicines agency, shows
numerous adverse effects and scores of deaths by suicide.

Yet the agency, even after repeated prodding by Larsson to initiate action,
has refused to budge or even acknowledge that there is a problem. MHRA
apparently accepts the drug’s producer Eli Lilly’s data rather than its own and
the
FDA’s adverse event reports.

Image credit: _Monheit Law_
(http://www.monheit.com/strattera/contact_lawyer.asp)

Larsson says: An investigation of MHRA™s handling of the harmful effects of
the ADHD drug Strattera has proven the following:

MHRA has ignored data about instances of death among children in connection
with Strattera treatment. At least 41 children have died. The agency has not
investigated the reported cases and does not even have a compiled summary of
cases with fatal outcome. Further the agency has allowed the manufacturer Eli
Lilly to give false information about the number of fatal cases and has
taken no action against the company once the false information was revealed.

MHRA has for almost three years been in possession of data proving that
Strattera can cause agitation, mania and psychotic reactions with hallucinations
among children. Yet no warning has been issued to doctors and parents. The
agency has withheld these disastrous consequences despite clear evidence. Due
to bureaucratic procedures no warnings have been issued even if Eli Lilly reluc
tanly conceded to include these harmful reactions in its information to the
public almost a year ago.

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing œpsychomotor hyperactivity. Lilly called
this an exacerbation of the œunderlying ADHD. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done“ not even from the manufacturer.
The background data for these conclusions can be found in the following text
and in the linked documents. When reading the data below please remember the
promise from the MHRA: we take any necessary action to protect the public
promptly if there is a problem._MHRA, About us_
(http://www.mhra.gov.uk/Aboutus/index.htm) [1]

Note that the linked documents (within letters described below) in most
cases could not be obtained in UK where the issuance of them would be deemed as
prejudicing œthe ability of the Assessory body to offer impartial advice and
where the MHRA wants to allow marketing authorisation holders the chance to
respond to regulatory action and make commercial decisions before data are
in the public domain. (MHRA, e-mail about FOIA-request, 29th September,
2006). However the documents could be obtained in Sweden, even if the MHRA has
tried to stop the issuance of them by implying that publication could threaten
the relations between Sweden and UK.
Deaths among children in connection with Strattera treatment

In May I submitted detailed data about cases of Strattera death to the MHRA.
1st October I finally got an answer from the Scientific Assessor of the
Vigilance and Risk Management of Medicines (VRMM). 7th October I got an answer
from Professor Kent Woods, CEO of the MHRA, referring to the letter sent by the
Scientific Assessor.

My data about Strattera deaths can be found _in the letter_
(http://jannel.se/Strattera.death2.pdf) Strattera: Eli Lilly gave false
information about
deaths from Strattera treatment “ a request for full investigation from 15th
May. [2]
The answer from the Scientific Assessor shows that MHRA is continuing to
ignore data about instances of death among children and adults in connection
with Strattera treatment. Despite limited resources and having to rely on data
released by reluctant medical agencies I had been able to produce a summary of
reported cases of Strattera death. Thats much more than the MHRA, with its
immense resources, had been able to do.

The agency was provided with specific data about instances of death forming
an excellent starting point for a full investigation. But instead of using
the data the MHRA used its energy to explain why it is impossible to
investigate these cases further, and in doing so presents some remarkable
comments.

The Scientific Assessor states _in the letter 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3]:

in order to calculate the total number of reports with a fatal outcome
it is not simply a case of adding up reports with a fatal outcome mentioned
in our assessment reports of the PSURs [Periodic Safety Update Reports] and
those available on the FDA website as these different sources may contain
duplicate information. [Emphasis added.]

I fully agree and it takes only a casual reading of my letter from 15th May
to find out that much care has been taken to exclude possible duplicates. It
is quite easy to see that the data presented about fatal cases in my letter
is NOT simply a case of adding up reports with a fatal outcome. The only
way to come to another conclusion would be not to look in the first place and
it is a condemnation of the effectiveness of the agency to state the following
in the letter:

We have looked at the data you have sent us to see if they can add insight
to the statutory sources of data we have received and do not think that they
are of benefit as we cannot verify their source or accuracy. (p. 3)
[Emphasis added.]

I must add to all the data provided in my letter 15th May that the our

of the information about fatal cases is FDA™s Medwatch system and the PSURs
(submitted directly to the MHRA). I must make it clear that is very easy for
a lay person to find out that almost all reports about fatal outcome from
Strattera treatment submitted to the FDA came from Eli Lilly!

Thus the our of the information about fatal cases was in most of the
cases the manufacturer itself“ Eli Lilly. And yet the MHRA has not been able
to verify the source or accuracy of the information. The MHRA Scientific
Assessor states in the letter:The sources of data that regulators use such
as company data, spontaneous adverse reaction reports and literature are set
out in European and national law.
My FOIA request earlier this year to get a compilation of fatal cases in
connection with Strattera treatment was answered 12th August:

Thats very good and now we know that the data I submitted to the MHRA about
all fatal cases from Strattera treatment “ in the absolute majority of cases
were known by and reported via the manufacturer Eli Lilly.
The MHRA holds no data other than that previously released to you [the
misleading data from Eli Lilly in November 2007, see my letter from 15th May
for
more data] which was the data provided by the company. If you have any
questions about FDA data or the data provided by the company, you should
contact those organisations.

In other words the MHRA didn’t have a compiled summary of cases with fatal
outcome in August and the agency has not to this point been able to compile
such a summary.

As the agency has not been capable of getting the data or not even been
capable of using the specific data submitted for its use in a full
investigation NO action is taken despite the many verified deaths among
children in connection with Strattera treatment. This disregard for the safety of children is a scandal which should lead to a full formal investigation by the
Department of Health.

Drug induced agitation, mania and psychosis with hallucinations

Ive been contacted by parents asking if Strattera can induce mania and
psychosis with hallucinations. Their children have had such symptoms. The
parents have not found any warnings about it and their childrens doctors don’t
think that the symptoms are caused by the drug. The parents were desperate.

However the MHRA has known for almost three years that Strattera can cause
agitation, mania and psychotic reactions with hallucinations among children,
but has refused to issue warnings about it.

The Scientific Assessor from the MHRA _in the letter of 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3] now confirms my
earlier arguments that the agency had knowledge about these effects a long time ago:

following an initial request in the assessment report for the Periodic
Safety Update for the period (dates 27-05-2005 to 26-11-2005) we asked Eli
Lilly for more information to enable us to review this issue in more detail. (p. 2)

This means that in the period ending 26th November, 2005 at the time when
Strattera was approved only in UK and four other European countries, but not
in the 22 additional European countries where it is now approved Eli Lilly
and the MHRA had knowledge about these disastrous effects in children taking
Strattera. But neither the MHRA nor Eli Lilly told anything about it and
Strattera was approved in 20 additional European countries in April 2006.
Image credit: _Wikimedia Commons_
(http://commons.wikimedia.org/wiki/Image:Strattera_atomoxetin.jpg)

Professor Kent Woods, CEO of the MHRA seems to be very misinformed by his
staff when answering about Strattera in a recent _letter of 7th October, 2008_
(http://jannel.se/answer.kent.woods.pdf) . In the letter Professor Woods
states [4]:

The MHRA is committed to ensuring that all safety concerns are subject to
robust scientific assessment and the best possible regulatory action is taken
in a timely manner. We strive to maintain the highest standards of work and
review our practices to ensure these standards are maintained or improved
upon where necessary. (p. 1)

In their 3rd March, 2006 report Psychiatric Adverse Events Associated with
Drug Treatment of ADHD: Review of Postmarketing Safety Data [5], the FDA
stated that there was compelling evidence for a likely causal association
between [Strattera/amphetamine drugs] and treatment emergent onset of signs and/or
symptoms of psychosis or mania, notably hallucinations, in some patients.

(p. 17) 360 reports about the drug inducing these effects had been received
up to June 2005.

From this FDA report the MHRA had knowledge about the œcompelling evidence for Strattera causing these effects on or about 3rd March, 2006 but did nothing.

In August the same year (2006) the MHRA requested the same data set from Eli
Lilly that was submitted to the FDA and which formed the basis of the FDA
report for Strattera. The data was sent to the MHRA some days later. But the
agency then decided not to do anything with the information. Instead it was
decided that Eli Lilly the manufacturer should do an analysis of the data
and submit its conclusions to the agency.

Professor Kent Woods says in his letter: An important aspect to this [ robust scientific assessment, highest standards] is ensuring that data from all available sources have been consider This may be true in some other area but it is definitely not true for the
safety work around Strattera. A very good example of this is the complete
rejection of the robust scientific assessment of Strattera in the FDA report.
Answering the question why the agency did not use the compelling evidence for harm in the FDA report _an official at the MHRA declared in a letter_
(http://jannel.se/mhraanswer.pdf) [6]:

Changes to European product information are based on assessment by EU
regulators, agreement between member states and in line with legal requirements
about product information, not on conclusions of FDA assessors. (25th May,
2007) [Emphasis added.]

Responsible officials at the MHRA had instead decided to rely completely on
the analysis of the manufacturer of the drug Eli Lilly. (In an article in
the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and
Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented:
Asking a drug company to review its own product is crazy, but it goes on quite a lot.
) [7]

At the end of 2007/beginning 2008 Eli Lilly submitted its review of
Strattera induced agitation, mania and psychosis with hallucinations to the
MHRA. It was a complete whitewash.

In summary: FDA was very clear about the psychosis-inducing effects of
Strattera; the MHRA did not listen. Instead the MHRA turned to the
manufacturer. Eli Lilly tried to explain away all the bad results found in its review. For
the full history about MHRA’s failure in this area and for a comparison of
the FDA report with the Lilly report, please see the following letter: _The
ADHD drug Strattera“ actions needed now_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] from January 2008, and
the letter _The ADHD drug Strattera“
an analysis of reports of drug induced mania, psychosis and hallucinations_
(http://jannel.se/strattera.mhra.March.08.pdf) [9] from March 2008.

In the letter from March [9] Eli Lilly’s whitewash report for the period up
to November 2007 is presented. At the end of that report Lilly says [10]:

Nevertheless, Lilly will consider adding language regarding psychotic symptoms
including hallucinations to its product information sheet. (p. 1279)

Larsson – _Suicides & Psychiatric Drugs_
(http://www.newmediaexplorer.org/sepp/suicide.psychiatricdrugs.pdf)

And so we come to October 2008 and the letters from Professor Kent Woods and
from the Scientific Assessor for Strattera. We are reassured that the MHRA
is acting to ensure that Strattera is used as safely as possible that

all safety concerns are subject to robust scientific assessment and the best
possible regulatory action, that any new safety signals are evaluated in
an independent, scientifically robust manner (Woods); we are told that

discussions between European Member States and Eli Lilly are ongoing to agree
on the most appropriate information to be included in the product information
for patients and prescribers; we are told to be patient, to understand that
it takes time from the point where œupdates have been agreed for inclusion in
the product information to the point where these will appear in the packs
in the market place due to movement of stock in the supply chain, and that
the appearances are estimated to be within the next 6 months (Scientific
Assessor).

It is probably hard to find a more obvious violation of the promise¦ we
take any necessary action to protect the public promptly if there is a
problem than the case described above. The worried parents still have no answers if
Strattera can induce the symptoms they find in their children. And the MHRA
knew about it three years ago but withheld the data. This should be
included in the investigation of the agency by the Department of Health.

Strattera causing hyperactivity“ the condition it was supposed to alleviate In my earlier letter to the Department of Health (29th August) I took up the data about the 700 forgotten cases of hyperactivity. I referred to my _letter 2nd January to the MHRA_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] and gave data about the
fact that Eli Lilly had withheld sensitive information and classified harmful effects as an exacerbation of the underlying ADHD.

The logical solution would have been for the MHRA to request all data about
this security risk, followed by an independent review of the data. But this
was not done and as expected nothing is still done. MHRA asked Lilly for an
explanation about this signal stemming from Periodic Safety Update Report
5 (dates 27-05-2005 to 26-11-2005) but got no answer. Three years later the
Scientific Assessor from the MHRA writes in the letter from 1st October:

The information submitted by the MAH [Market Authorization Holder] has been
evaluated and the MAH will be requested to provide further detailed
information within the next 2 months to ensure the issue has been investigated
in a thorough and scientific manner. (p. 2) [3]

The MHRA got this safety signal almost three years ago and is still in
the process of getting some sensible answers from Eli Lilly.

————

I again request the Department of Health to take action. This does not
concern only the children in UK; it concerns the children in the whole of
Europe, indeed it concerns all the children of the world.

The failure of the agency will also mean that psychiatrists within The
Guideline Development Group in NICE can push through more treatment with
Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for
harmful effects and the psychiatrists with close relations to the manufacturers
of the drugs can unimpeded recommend these medicines to unsuspecting
doctors and parents.

The answers given by Professor Kent Woods and the Scientific Assessor did
not in any way handle my concerns. On the contrary, they finally proved that a
full formal investigation of the matters raised above is needed.

Yours sincerely,

Janne Larsson

Reporter – investigating psychiatry
Sweden
_janne.olov.larsson@…_ (mailto:janne.olov.larsson@…)

[1] MHRA, About us, _http://www.mhra.gov.uk_ (http://www.mhra.gov.uk/)
[2] Larsson, Strattera: Eli Lilly gave false information about deaths from
Strattera treatment“ a request for full investigation, May 15, 2008,
_http://jannel.se/Strattera.death2.pdf_ (http://jannel.se/Strattera.death2.pdf)
[3] MHRA, Re: letter of 9th September 2008 to “Assessor responsible for
Strattera, October 1, 2008,
_http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf)
[4] MHRA, Re: Open letter to Pr. Kent Woods (10th August 2008), October 7,
2008
_http://jannel.se/answer.kent.woods.pdf_
(http://jannel.se/answer.kent.woods.pdf)
[5] FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD:
Review of Postmarketing Safety Data, released March 3, 2006.
_http://www.fda.gov/ohrms/dockets_
(http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.\
pdf
)
[6] MHRA, answer FOI request, May 25, 2007,
_http://jannel.se/mhraanswer.pdf_ (http://jannel.se/mhraanswer.pdf)
[7] Daily Mail, Heart attacks and suicides… yet the dangers were all kept
so quiet. So how CAN you trust your medicine? July 7, 2008,
_http://www.dailymail.co.uk/_
(http://www.dailymail.co.uk/health/article-1033132/Side-effects-include-suicide-\
heart-attacks-So-prescribed-drugs.html
)
[8] Larsson, The ADHD drug Strattera – actions needed now, January 2, 2008,
_http://jannel.se/letter.mhra.strattera.jan08.pdf_
(http://jannel.se/letter.mhra.strattera.jan08.pdf)
[9] Larsson, The ADHD drug Strattera – an analysis of reports of drug
induced mania, psychosis and hallucinations, March 9, 2008,
_http://jannel.se/strattera.mhra.March.08.pdf_
(http://jannel.se/strattera.mhra.March.08.pdf)
[10] Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania,
Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic
Safety Report 9 for Strattera, 2008,
_http://jannel.se/Lilly_psychosis_strattera.pdf_
(http://jannel.se/Lilly_psychosis_strattera.pdf)

See also:

_Doctors told to curb use of Ritalin in hyperactive children_
(http://www.timesonline.co.uk/tol/news/uk/science/article4813727.ece)
_Children’s suicide attempts raise concerns about ADHD medication_
(http://www.theglobeandmail.com/servlet/story/RTGAM.20080703.wadhd03/BNStory/spe\
cialScie

nceandHealth/home)
_The ADHD drug Strattera: Lilly to issue warnings about psychosis,
hallucinations, mania and agitation_ (http://jannel.se/strattera.psychosis.doc)
_Strattera side effects_ (http://www.bonkersinstitute.org/stratteraffex.html)

_Strattera – 10,988 adverse “psychiatric reactions” reported in less than
three years_ (http://www.24-7pressrelease.com/view_press_release.php?rID=16662)
_Attention Deficit Hyperactivity Disorder? No, they’re just naughty, say
experts_
(http://www.dailymail.co.uk/news/article-1031436/Attention-Deficit-Hyperactivity\
-Disorder-No-theyre-just-naughty-say-experts.html#
)

Withdrawing from a Decade of Drugs

“I have a few shopping bags full of drugs given to my son.”

Dear Ann Blake Tracy,

I don’t really know where to begin but I will try. Your website is incredible and anyone thinking of letting the psychiatric system help a loved one or any human for that matter should read your books, listen to your tapes and fine comb your website.

Our horror story began in 1995 and hasn’t stopped as of today Jan. 04, 2004. Our son (only child) is still withdrawing from the treacherous side effects of all the drugs given to him mostly by force throughout the last 10 years.

He is now 29 years old and having missed 10 years of living and learning is just starting to show signs of life.

Watching him almost die in front of me has taken a toll of my body and brain and we are recovering from this ordeal. Unlike many others who have lost their loved ones to these pretentious rehabs and treatment centers has endlessly aged and stolen time from our families happiness and our lives.

I have a few shopping bags full of drugs given to my son. There are hundreds of containers of Luvox, Prozac, Buspar, Ativan, Paxil, Celexa, Thorazine, Mellaril, Serentil, Prolixin, Haldol, Risperdal, Zyprexa, Stool Softeners and many others I cannot remember. In fact I had to take a breather remembering all these poisons.

The suicide attempts and induced anger created by these cocktails of poisons is unspeakable. People who do not understand the routine drugging regime of humans who get caught up in this system need to be informed before we have nothing but drugged humans living on this earth.

There are no quick fixes for human feelings and no drug will prevent anyone from feelings we are born to feel.

We know what Tardive Dyskinesia looks like and we know what acute Akathisia is all about and Tardive Dystonia. We have spent endless nights in emergency rooms and hospitals only to see our son drugged and misunderstood like the others who happen to be locked up at the same time. We have met hundreds who have been warehoused, committed, Conserved, etc. This system is nothing more than a pharmaceutical/psychiatric money making industry damaging humans and their families. We have spent thousands of dollars seeking help with little or no help to be found just more drugging and irreversible damages.

My friends Marilyn, Delores, Cathy, Felicia, Dorothy, Anne and many others know the truths about neuroleptics and SSRI’s. We live with poisoned humans and some of us lived together as we tried everything to help our loved ones withdraw from Mind Altering Chemicals.

Linda Valentine
lindaraps97@yahoo.com

Losing a Sense of Being on Luvox

“I have felt ‘dead’ ‘doped’ and ‘stunned’ on the various medications I have been prescribed.”

 

I was prescribed Luvox in May this year (2002) as I suffer from O.C.D. (for 28 years), chronic insomnia and depression. I also cope with life to a great degree, by employing magical thinking.

I had the Luvox in my possession for a few weeks before I finally decided to take it one night, as I couldn’t cope with waking up again knowing I hadn’t done anything (medication wise) to improve my situation. (In principal, I am against medication as, since I was first diagnosed with O.C.D. and depression (about 13 years ago), I have felt ‘dead’ ‘doped’ and ‘stunned’ on the various medications I have been prescribed).

In short, the Luvox kept me awake all night, (and has continued to do so (it is now December).

My doctor prescribed co-medications (Mogadon and Alprazolam). Mogadon to knock me out to sleep, and Alprazolam to calm me down, as I was awake all night due to extremely fast palpitations, confused & abstract thinking, exceptional alertness, and a total inability to ‘switch off’. I also experienced occasional auditory hallucinations, which had only been previously present on two occasions in my life, when I was medicated.

In general, I am not prone to hallucinations. The Mogadon knocked me out so that I couldn’t get up to drive children to school. I have recently (a week and a half ago) gone off the Luvox. In the meantime I have become addicted to Temazepan, as my insomnia has continued.

My choice now has been to work with a dedicated professional, who is willing to work without medication via hypnosis and psychotherapy and to attempt to reduce the sleeping medication myself and eventually deal with the insomnia in any way possible whilst my children are on school holidays.

Although I most certainly recognize the need and value of medication, my experience has always been that the side effects are so complex, and in the end, the co-medications make the situation so much worse, and one totally loses any sense of ‘being’.

Australia

 

12/27/2002

This is Survivor Story number 3.
Total number of stories in current database is 48

Luvox withdrawal

“About a week or two after I had quit, I finally cried again. I knew then I was on the right track–I could feel again! “

 

After being on Luvox for two years, I took myself off of it “cold turkey.” (I had read that either way you go, “cold turkey,” or gradually reducing the dosage didn’t matter that much). Why did I decide to quit taking it? Because I just could not stand the side effects any longer. The side effects were terrible nightmares, severe constipation, and sleepiness, inability to think clearly, discomfort and discharge from my eyes, and an overall feeling of ill-health, plus I couldn’t cry. The drug was not “buying” me enough relief from depression to justify taking it. The only “good” things it did for me was allow me to sleep, and provide the initial relief from depression (may have been more related to the “placebo” effect of finally addressing the problem!). I think my problems could have been addressed more intelligently through counseling, group therapy, and a sleep aid, exercise, etc.

I have been off of Luvox for about two months. The withdrawal symptoms were/are frightening. The scariest symptom was dizziness. I thought I was going to have a stroke, or than I had a brain tumor. I went to see my doctor because I was so frightened by the dizziness, and a weird sensation in my head. He didn’t attribute that to going off of the Luvox, but thought my neck arteries may have been clogged, so he listened to those with a stethoscope.
About a week or two after I had quit, I finally cried again. I knew then I was on the right track–I could feel again! And I notice that although I still have the weird dreams, they are getting more “normal” now. (By the way, the nurse practitioner had told me that it was my psyche that was causing the “bad” dreams, and she also added that these SSRI’s don’t have significant side effects!).

I still have some dizziness, but it is getting better. Oh I forgot to mention the awful muscle pain I had the first few weeks I was off of the drug. It was frightening also. I thought I had some terrible muscle disease.

I am sharing this to help others. I can’t tell you how happy I am that I found out about this web site! Today, is the first day I have known that this dizziness was a part of the withdrawal! Imagine how worried I have been!

Please share my e-address; I would be happy to e-mail with another Luvox survivor, and hear from anyone who wants to talk about that drug.
Thank you so much!

Dorothy Wilson
dotwilson@attbi.com

 

9/29/2002

This is Survivor Story number 10.
Total number of stories in current database is 48

Eight-year Old Becomes Aggressive on Luvox

“I’m still angry at the psychiatrist for putting him at risk with these drugs.”

 

They prescribed Risperdal and Luvox to my eight year old son years ago for panic attacks. He started acting strangely and hurting other kids, something he’d never done before, so I stopped giving him the drugs after a few days but I still had to have them filled or DFCS would have claimed I was “psychologically neglecting” him, that’s why I had taken him to the psychiatrist in the first place, his pediatrician reported me after she “suggested” he see a shrink and I told her I didn’t believe in them. He’s almost 16 now, and perfectly fine, but I’m still angry at the pediatrician, DFCS, and the psychiatrist for putting him at risk with these drugs.

 

9/10/2002

This is Survivor Story number 11.
Total number of stories in current database is 48

6/26/2001 – Part 1 – Creating an Epidemic of Columbine Shooters!!!

This week I was interviewed on CNN about new “research” on treating anxiety
in children with the SSRI, Luvox.

[I will first send you research out of Australia about anxiety and serotonin
levels along with an e-mail that just came in from a mother whose son had his
life ruined by Luvox and then I will send the Washington Post article next on
the study.]

I must say that we have taken insanity to an all new height with this recent
study out on anxiety in children. The same drug Eric Harris was on in the
Columbine High School shooting, Luvox, is the drug that was used in this
study to treat anxiety in children. But look at what behavior was considered
to be abnormal enough to give this drug that has “psychosis” listed as a
“frequent” side effect!

“Extreme separation anxiety disorder, he said, would be displayed in a child
who avoided birthday parties and sleepovers. A medium-grade example would be
children who refused to sleep in their own rooms and wanted to get into bed
with their parents.”

Now I don’t know about the rest of you, but I had a child that often jumped
in bed with mom and did not like birthday parties very much. Given a choice
between waiting for children to grow out of that as opposed to drugging them
into psychosis, should not be a difficult choice at all!

We don’t get to enjoy these little children in our lives for very long.
Before we know it they are grown and gone. Why not enjoy the short time they
want to crawl into bed with mom and dad to be cuddled and reassured that
everything is okay? But to look at this as a serious mental disorder for
which they need to be drugged?!! This is greed beyond anything imaginable!

When we look at the science behind anxiety disorders the insanity grows by
leaps and bounds because medical research over the last several decades has
continued to show (as documented in Prozac: Panacea or Pandora?) that
anxiety, along with other mood disorders, is associated with ELEVATED levels
of serotonin, rather than decreased levels of serotonin. So in a patient
suffering from anxiety, WHY would we want to increase already elevated levels
of serotonin with an SSRI?

Dr. Murray Ellis at the Baker Medical Research Institute in Melbourne,
Australia found last year that 75% of those suffering from various anxiety
disorders had EIGHT times higher levels of serotonin even on days when they
did not demonstrate anxiety symptoms.

So, as I asked on CNN, I once again ask, “Why on earth would we want to do
anything to increase serotonin in those who already demonstrate symptoms of
ELEVATED serotonin?”

My heart aches for these children who were tortured and maimed as guinea
pigs, given this deadly drug for the sole purpose of increasing the profits
of those who still have their hands dripping with the blood of all the
Columbine victims.

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

http://theage.com.au/news/20000514/A59189-2000May13.html

Dramatic reversal in research on anxiety

By STEVE DOW
Sunday 14 May 2000

Startling and unexpected findings on panic disorder patients could
fundamentally change the way anxiety and anxiety-related depression are
treated.

The findings by Melbourne’s Baker Medical Research Institute, presented to a
recent scientific meeting and soon to be submitted to the medical journal The
Lancet, have unsettled scientists and turned upside down their ideas on brain
chemistry among the anxious.

But the evidence from the work by cardiologist Professor Murray Esler and
colleagues is so strong that it is being taken seriously.

The scientists tested the levels of the mood-regulating chemical serotonin in
20 patients who suffer panic attacks and found that, even on a good day, the
average levels of the chemical in the brains of at least 15 of the patients
were eight times higher than normal.

Until now, the theory has been that anxiety, panic and anxiety-related
depression are caused by a lack or underactivity of serotonin in the brain.
Based on this theory, the selective serotonin re-uptake inhibitor (SSRI)
wonder drugs that emerged in the ’90s – marketed as Prozac, Aropax and Zoloft
– are intended to increase serotonin around the brain neurons involved in
anxiety.

Professor Esler emphasised that the SSRIs were “great drugs” and should
remain worldwide bestsellers.

However, there were two important implications of the new research, he said.

First, the conventional view of how SSRIs operate has been challenged. It
would appear that the drugs are effective because, over time, they somehow
decrease, rather than increase, serotonin as originally thought.

Second, the new findings could spark drug companies to create drugs that stop
serotonin directly. Such a response might stop the common problem of
“serotonin agitation” experienced by many patients on SSRIs. These patients
experience increased anxiety in their first weeks of treatment on drugs such
as Prozac, Aropax and Zoloft; the drugs making the problem “worse before they
make it better”, Professor Esler said.

He said there was now compelling evidence that panic disorder and depression
were on a par with high blood pressure and smoking as risk factors for heart
disease. A study of several panic disorder patients had shown a spasm of
coronary arteries was common after an attack. One patient, a woman of 40,
suffered a clot and subsequent heart attack because of her panic disorder.

The Baker Institute wishes to recruit patients who suffer panic disorders and
depression for future studies. Contact the institute on 95224212.

NEWS 14: The Health Report
_____________________________________

Teenager on Luvox – aggressive, homicidal
3/26/01

This letter is for your feedback section on the net. In July of 1999 our son,
then 14 years old, was started on Luvox by a psychiatrist for treatment of
his compulsive behavior. We had actually taken him there for treatment of
depression, but the doctor said he was depressed because of his compulsive
disorder. As our son was 6 foot tall and 300+ pounds, the doctor eventually
had him on a dose up to 300 mg a day. Our son started to act very aloof and
irritable. When he was depressed he talked about killing himself, he would
sleep a lot, and he drew pictures of guns. But once on the Luvox, he became
aggressive towards us and would swing at us at the least provocation.

Just before Christmas he came up to me, his mother, and said, “Something is
wrong with me,” but he couldn’t explain it. I didn’t realize at all what he
meant. On Christmas he opened his gifts methodically with no expression on
his face. He had always loved this holiday and now he was acting like a
zombie.

In the winter of 2000, we got a call from his school that he had threatened
some people. The police were called. Apparently our son, who had never done
anything wrong in school or out, had been talking in the cafeteria about
killing the family of a girl he knew, then killing her. He went into graphic
detail and then looked at two boys who were sitting nearby listening and said
to them, “If you tell anyone, I’ll kill you”. The boys turned him in.

We found out through interviews the police had with other kids in the school
that our son had also plotted the same demise for another family of a girl he
knew. He had told this girl to her face. She and her family, however, knew
our son and knew this was not his normal behavior. They therefore did nothing
about it.

To make a long story short, he was arrested but not taken to jail
immediately because we begged to take him home and watch him 24 hours a day.
He had to be drug tested. He had to go to a partial program for troubled kids
for two weeks. He was given 10 days out of school suspension and the story,
of course, went all over the school. He lost his best friend because the
mother would not let him hang around with our son anymore. No one called to
support him or us. We were isolated from the community. We had to hire a
lawyer because the local police wanted to put him in jail. They had written
up a report that made our son look like he was insane. The report went to the
juvenile court and Children’s Services. We were visited by Children’s
Services and interviewed. Our son went through approximately three different
psychiatric evaluations; however, all of these were done after he was taken
off the Luvox. We had taken him off the drug after this all happened because
we were afraid it might have caused his behavior problem. I had read about
Columbine and knew the boy involved had been on Luvox too. The psychologists
who evaluated him found him to be fine except for depression; again, these
evaluations were after he was taken off the Luvox. Everyone who interviewed
him after he was off the Luvox could not believe he had threatened people
the way he did, he was not the same person.

We were lucky enough to have the case dismissed as it was our son’s first
offense as a juvenile and our state allows one mistake. They supposedly
closed the file, but the local police will have it open until our son is 18.
In the meantime, if he gets into any trouble, they will use it against him.

We pulled our son out of school and homeschooled him to keep him away from
the cruelty of the kids at school. We had to have him tutored and sent him to
summer school so that he could keep up with his class. He is now called a
“Sophomore” instead of a “Junior” because he was short 3/4ths of a credit,
even with all of our effort; although he will graduate with his class as a
Senior next year. The school told us he just won’t ever be a “Junior”. Our
son faces taunting to this day, not as bad as when he first went back to
school in the fall. A boy said “rape” next to him in class and a girl in the
class told her mother and the mother called the police about our son because
she had heard the story and thought he was the one talking about rape. The
guidance counselor told him this year that he has to watch everything that he
says. He cannot say certain words at school, like “gun”, “shoot”, “murder”,
etc because he could get in trouble.

This child will never be the same because of Luvox. His high school years are
a nightmare now and people in this small town will know him as being
“dangerous”. On the bright side, the families of the two girls that he
threatened refused to file any charges against our son because they knew this
was not his usual behavior and that something was “obviously wrong”.

The psychiatrist who gave our son the Luvox became very defensive immediately
after the episode and said that it was not the Luvox, it was our son. He said
that no cases had ever been won against SSRIs. He also told our son that what
he did was horrible, that nobody would ever forget it or forgive him and that
even if he went to another school, they would find out about it.

Can you imagine a psychiatrist saying this to a patient? Needless
to say, we left him after the legal aspect of the case was closed.

My son told me later that when he was on Luvox, he wasn’t afraid to do
anything. He said he had “no fear”.

We hope this will help make people aware of the dangers of Luvox and the
other SSRI drugs. I only wish there was some way to help the people like my
son who have lost so much to this drug.

Please do not print our name or our e-mail address.

4/26/2001 – Part 2 – Luvox study on anxiety

http://www.washingtonpost.com/ac2/wp-dyn/A2512-2001Apr25?language=printer

Drug Found to Curb Kids’ Debilitating Social Anxiety

By Shankar Vedantam
Washington Post Staff Writer
Thursday, April 26, 2001; Page A01

Children who are so shy or so attached to their parents that they are afraid
to go to school or sleep alone do much better when given a psychiatric drug,
according to a major study with profound — and controversial —
ramifications for millions of children.

The study of 128 children ages 6 to 17 found that the drug Luvox, widely
prescribed for adults with depression, alleviated the debilitating symptoms
of social phobia, separation anxiety and generalized anxiety — psychiatric
illnesses that afflict as many as 1 in 10 U.S. children.

The effects of the medicine were dramatic, but experts were divided about its
appropriateness: The medicine can help children with severe emotional
problems, but it might also be abused as a chemical quick fix for normal
anxiousness, with lasting effects on growing brains.

“Although the results seem impressive, they nevertheless raise some very
important questions about the use of psychotropic medications in children,”
said Joseph Coyle, chairman of psychiatry at Harvard Medical School, in an
article accompanying the findings in today’s New England Journal of Medicine.

“Any drug that is effective is not going to be innocuous,” he said in an
interview. Children and adolescents diagnosed with these disorders should
first try a form of therapy known as cognitive behavioral therapy, and turn
to medication only if that fails, he said.

An estimated 575,000 children nationwide were diagnosed with anxiety
disorders in the 12 months ending in March, including 136,000 under age 10.
Doctors recommended 390,000 children be put on medicines such as Zoloft,
Paxil and Prozac. Of these, 89,000 were under age 10, according to IMS
Health, a private company that tracks the pharmaceutical industry.

Such vast numbers leave critics aghast. Too many children are being put on
powerful brain-altering drugs for behaviors that may be merely troublesome,
critics say. But other experts point out that many children suffer from
distress that, left untreated, can cause impairment well into adulthood.

“Researchers found that anxiety was among the most common problems that kids
have,” said Daniel Pine of the National Institute of Mental Health. He led
the study. “When researchers follow children with anxiety over time,
sometimes anxiety developed into more chronic problems. It could be the
harbinger of problems with depression, panic attacks and all different kinds
of problems.”

The study, the first large, well-designed survey to examine the effectiveness
of a psychiatric drug for a wide range of anxiety disorders in children, was
partly funded by the National Institute of Mental Health and by Solvay
Pharmaceuticals, which sells Luvox. The drug, which like Prozac increases
levels of the brain chemical serotonin, has been approved for the treatment
of obsessive compulsive disorder in children. Luvox sales were more than $2
billion in the United States last year, according to IMS Health.

Scientists at Johns Hopkins University, Columbia University, New York
University, Duke University and the University of California at Los Angeles
studied the drug over eight weeks in children with anxiety disorders.

An example of a child with severe social phobia would be one who refused to
go to school for two weeks, said Mark Riddle of the Johns Hopkins University
School of Medicine, one of the study’s authors. A milder example, he said,
would be a child who went to school and participated in clubs and group
events, but with intense discomfort.

Extreme separation anxiety disorder, he said, would be displayed in a child
who avoided birthday parties and sleepovers. A medium-grade example would be
children who refused to sleep in their own rooms and wanted to get into bed
with their parents.

Generalized anxiety disorder, Riddle said, were “the worrywarts.”

“A lot of it would be about performance — getting very preoccupied with a
test at school, a lot of fussing about day-to-day things,” he said.

“We don’t want a Prozac nation,” he said about the medication of children.
“We want to make sure we are not doing anything to harm youngsters. On the
other hand, it can be a huge disservice to children to minimize the true
significance of psychiatric impairments that do require treatments. It’s the
latter that can get lost in the very easy and popular position to take, which
is ‘Don’t drug our kids.’ ”

Richard Harding, president-elect of the American Psychiatric Association,
said clinicians should carefully evaluate anxious children to find out
whether their fears are caused by an underlying personality problem — which
would merit psychotherapy or medication — or by a social problem, such as a
bully in school or child abuse at home, in which case medication would be
inappropriate.

“A good clinician will not commit a child to a life sentence on medicine,”
said Riddle. “A good clinician will look to stop medication after the
youngster has had a chance to regroup. You want to work with a clinician who
says we are going to get John off this medication.”

It is unclear what impact this study will have in clinical practice, where
doctors are prescribing children such medicines “off-label” — meaning they
have not been approved for such uses by the Food and Drug Administration.

“Given our current medical-economic system in practice, I suspect both
doctors and parents will be strongly attracted to the quick-fix nature of
this intervention,” said Lawrence Diller, a behavioral pediatrician in Walnut
Creek, Calif., and the author of “Running on Ritalin.”

“We have highly effective psychosocial interventions for these problems,” he
said. But “they are more expensive and take longer.”

He said that helping families come up with parenting strategies could ease
children’s anxieties. “Children are highly responsive to their environments,
and the home is the practice arena to deal with life,” he said. “This is not
parent-blaming — children are difficult to raise. But when the parent makes
changes, you see very rapid changes in the child.”

“It doesn’t negate the value of the medications,” he added. But “with
uncertainty on both sides, effective psychosocial treatments — first do no
harm — take preference.”

More extreme critics, such as Bethesda psychiatrist Peter Breggin, said the
study was produced by scientists who are part of an “old boys’ network of
drug pushers.” He said the psychiatric drugs cause harm — some data have
shown that the drugs cause lasting alterations in the brains of young animals.

Researchers involved in the new study said the drug was well tolerated and
safe.

© 2001 The Washington Post Company

4/19/2001 – Ann Blake-Tracy on the air with Columbine victims

* Before I give you this information on the Columbine shooting victims, you
should know that it was announced today in San Diego that Jason Hoffman, the
school shooter in El Cajon, had taken two different antidepressants.

Now for a little over a month I have been working with the victims of
Columbine shot by Eric Harris, and the Harris family attorney, as they have
prepared their lawsuits against Solvay, the makers of Luvox. We have been
invited by the largest talk radio station in Utah, KSL, to do a show with
Doug Wright. It will air Friday, April 20, (the anniversary of the Columbine
tragedy) at 10:00AM Mountain Time.

Another show will air Monday morning on KIQ 1010 in Salt Lake City with Joe
Jackson at 8:00AM Mountain time.

You can find the particulars on how to listen to these shows online or you
can find information on any other upcoming shows by going to:
http://members.aol.com/atracyphd/appear.htm

Check this site regularly for upcoming shows you can listen to online. If you
would like a show in your area contact your local station and tell them to
log on to www.drugawareness.org and let us know when they would like us on
the air.

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

Two Months of Hell on Luvox, Effexor, Paxil and Zoloft.

“Why don’t they tell people? What are they trying to do to us?”

 

Hi, I am not a teenager, but I was put on my first anti-depressant at 25 years of age. I was mostly depressed about my relationship at the time, but had always been anxious and unmotivated so I thought the doctor was correct.

I lived through two months of absolute Hell. First Luvox, then Effexor, then Paxil, then Zoloft…all of which I had severe tremors and dystonia while taking within days. My Dr. acted like I was psychosomatic. I became so ill during this time that I don’t recall half what happened. My now husband said it was terrifying to see me.

I quit the Doctor and am now 29 years of age. My memory is shot and if I was unmotivated prior to this, I can only say that now I am completely apathetic and disinterested in almost everything. I have tried naturopathy, acupuncture, etc. Nothing helps.

I had a minor problem before and now I think my life may be ruined. Why don’t they tell people? What are they trying to do to us?

Thank you for your page. It means a lot to know I am not alone if nothing else.

Yana
yana97@prodigy.net

Years 2000 and Prior

This is Survivor Story number 91.
Total number of stories in current database is 96

Four Weeks after Luvox, I Feel Dizzy, Lethargic and Fatigued.

“I still feel terrible – a lot worse than I did before ever taking it.”

 

Four weeks ago I discontinued Luvox because of side effects. I was on a very low dose but still did not like the reaction from it. It has been four weeks now and I still feel terrible – a lot worse than I did before ever taking it. I have been told it can take awhile for these symptoms to go away. I feel dizzy at times, lethargic, fatigued, headache, certain foods make it worse. I have also noticed if I eat turkey I get real confused and tired. What is going on with me, and how long does it take? I should have learned better than to take these from my experience with the Serzone I took for two weeks. It took about two months for me to feel normal again, I was dizzy and sick and tired.

Remember, as I mention in my book, that turkey is one of the foods with high levels of tryptophan, a precursor of serotonin. When a toxic level of serotonin is reached due to the use of these SSRI’s adding anything that will increase serotonin will trigger adverse reactions. Turkey is one of the worst for producing reactions.

Ann Blake-Tracy

Years 2000 and Prior

This is Survivor Story number 60.
Total number of stories in current database is 96