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SSRI-Research@

Sun, 18 Sep 2005 20:42:32 -0400

[sSRI-Research] Paxil-Induced Suicides

 

 

 

Paxil-Induced Suicides

 

http://paxilprotest.com/page22.html

 

 

The evidence, however, is clear,

these medicines are not

linked with suicide,

these medicines are not

linked with an increased rate of self harm.

 

-Dr. Alastair Benbow

Head of European Psychiatry for GlaxoSmithKline

10/3/2004

 

 

The fact is GlaxoSmithKline, like the other SSRI manufacturers, has

long been aware that SSRIs can cause people to kill themselves.

 

Paxil causes some people to experience a suicidal event; such events

are marked by:

 

 

a.. Suicidal thoughts

a.. Suicidal gestures (typically cutting of the body)

a.. Suicide attempts

a.. Actual death by suicide

 

The issue of SSRI-induced suicidality first came to the public's

attention in February, 1990 when two prominent Harvard researchers and

psychiatrists, Drs. Martin Teicher and Jonathan Cole published an

article entitled: " Emergence of Intense Suicidal Preoccupation During

Fluoxetine Treatment " which appeared in the American Journal of

Psychiatry. The article reported that " persistent, obsessive, and

violent suicidal thoughts [had] emerged in a small minority of

patients treated with fluoxetine. " The article goes on to state:

 

" The purpose of this report is to suggest the surprising possibility

that fluoxetine may induce suicidal ideation in some patients. In our

experienced, this side effect has occurred in 3.5% of patients

receiving fluoxetine, which provides an estimated incidence of

1.3%-7.5% with 95% confidence limits. "

 

Dr. David Healy, a prominent psychopharmacologist in Wales, recognized

this problem in his own practice and wrote " Antidepressant Induced

Suicidal Ideation " in 1991, along with two other researchers. It was

published in Human Psychopharmacology (Vol. 6, 329-332). The article

discusses two patients who became suicidal on Prozac. Drs. Healy and

Creaney came to the conclusion that " these cases suggest that the

emergence of suicidal ideation on antidepressants cannot always be

attributed to a lifting of psychomotor retardation but rather that the

ideas may in some instances be produced by the antidepressants. "

 

One particular researcher and psychiatrist at Yale, Dr. Robert A.

King, was also looking into the problem of SSRI-induced suicidality in

1991, particularly as it affected youth. As set forth in his

peer-reviewed article, " Emergence of Self-Destructive Phenomena in

Children and Adolescents during Fluoxetine Treatment, " he observed

that " self-injurious ideation or behavior appeared de novo or

intensified during fluoxetine treatment of obsessive-compulsive

disorder in six patients, age 10 to 17 years old, who were among 42

young patients receiving fluoxetine for obsessive-compulsive disorder

at university clinical research center. " Dr. King posed two possible

explanations for these reactions: 1) coincidence; 2)

medication-induced agitation, disorganization or mood changes.

 

It was not until 4 years later that Dr. King concluded that these

events were caused by the SSRI drug. In his peer-reviewed journal

article, " Serotonin and Suicidality: The Impact of Fluoxetine

Administration II. Acute Neurological Effects, " Isl J Psychiatry Relat

Sci Vol 32 No. 1 (1995)44-50, Dr. King concludes: " t appears that

a small, still poorly defined group of patients receiving fluoxetine

and other SSRIs experience a spectrum of adverse side effects ranging

from restlessness, extreme agitation and self-destructive impulses and

behaviors. "

One of the few truly epidemiological studies on the subject is

entitled " Deliberate Self-Harm and Antidepressant Drugs: Investigation

of a Possible Link, " by Dr. Stuart Donovan and colleagues. This large

scale, pharmaceutical company sponsored study demonstrated a

statistically significant relative risk of 5.5 for all SSRI

antidepressants.

Other studies yield a relative risk greater than 2.0. These include

Jick et al. " Antidepressants and suicide, " British Medical Journal

1995;310:215-218; Fisher et al. " Postmarketing surveillance by patient

self-monitoring: Preliminary data for Sertraline versus Fluoxetine, "

Journal of Clinical Psychiatry 56, 288-296 (1995); Fisher et al.

" Postmarketing surveillance by patient self-monitoring: trazadone

versus fluoxetine " Journal of Clinical Psychopharmacology 13, 235-242

(1993) (Exhibit 74); Donovan et al. " The occurrence of suicide

following the prescription of antidepressant drugs, " Archives of

Suicide Research 5, 181-192.

This association was also revealed in a study performed on healthy

volunteers by Dr. David Healy using sertraline and another drug called

reserpine. During this study, 2 of the 20 volunteers became suicidal

on sertraline. Dr. Healy attributed this to SSRI-induced suicidality

mediated through " a combination of akathisia and emotional blunting,

as well as automatism. " Dr. Healy's findings were published in a

peer-reviewed journal article entitled " Emergence of antidepressant

suicidality, " published in 2000 in Primary Care Psychiatry (Vol. 6,

No. 1).

Another article, published in 1998 on this subject, was by a Dr. M

Marsalek, titled " Do antidepressants increase risk of suicide? "

published in Ceska A Slovenska Psychiatrie 94 (5): 272-81. In this

peer-reviewed article, Marsalek states:

" Suicidal ideation and behavior can sometimes emerge in persons with

obsessive or panic features who take antidepressants or neuroleptics.

Typical for such state is rapid development, impulsive and/or

obsessive characteristic of suicidal ideation, an independence of the

course of depression, severe tension and anxiety, an intense violence

of suicidal fantasies and attempts, and their prompt disappearance

after the discontinuation of the antidepressant. . . . There is

clinical evidence of the link between akathisia and suicidal

tendencies. . . . The reduction or the discontinuation of

antidepressants or neuroleptics, and the treatment with

benzodiazepines or beta blockers should be recommended when the

drug-induced suicidal tendencies are recognized. "

The above are but examples of the multitude of medical journal

articles on the subject.

Despite GlaxoSmithKline's protestations to the contrary, it is

generally recognized that SSRIs, including Paxil, can cause

suicidality. Not only is this reflected in the current DSM IV TR, it

appears, repeatedly, elsewhere.

*******************

In a 2001 court case, a jury found that Paxil caused a man in Wyoming

to kill his wife, daughter, granddaughter - and himself. On June 6,

2001 a verdict was rendered in Tobin v. SmithKline in a Wyoming

district court. The jury instructions and jury findings (in bold) were:

1) Can Paxil cause some individuals to commit suicide and/or homicide?

(general causation): YES.

2) Was Paxil a proximate cause of these deaths? (specific causation): YES.

3) What amount of fault do you attribute to each of the following:

a.. SKB: 80%

a.. Don Schell: 20%

4) Damages: $8,000,000

Excerpts From Paxil's June, 2005 Prescribing Information

Clinical Worsening and Suicide Risk: Patients, their families, and

their caregivers should be encouraged to be alert to the emergence of

anxiety, agitation, panic attacks, insomnia, irritability, hostility,

aggressiveness, impulsivity, akathisia (psychomotor restlessness),

hypomania, mania, other unusual changes in behavior, worsening of

depression, and suicidal ideation, especially early during

antidepressant treatment and when the dose is adjusted up or down.

Families and caregivers of patients should be advised to observe for

the emergence of such symptoms on a day-to-day basis, since changes

may be abrupt. Such symptoms should be reported to the patient's

prescriber or health professional, especially if they are severe,

abrupt in onset, or were not part of the patient's presenting

symptoms. Symptoms such as these may be associated with an increased

risk for suicidal thinking and behavior and indicate a need for very

close monitoring and possibly changes in the medication.

There is a Risk of Suicidal Thoughts or Actions: Children and

teenagers sometimes think about suicide, and many report trying to

kill themselves. Antidepressants increase suicidal thoughts and

actions in some children and teenagers.

The following symptoms, anxiety, agitation, panic attacks, insomnia,

irritability, hostility, aggressiveness, impulsivity, akathisia

(psychomotor restlessness), hypomania, and mania, have been reported

in adult and pediatric patients being treated with antidepressants for

major depressive disorder as well as for other indications, both

psychiatric and nonpsychiatric.

Click on this link to see an IMR model for extrapolating the number of

SSRI (including Paxil)-related suicides.

If you, or someone you know, has become suicidal (or took their life)

while on Paxil, please report it immediately to the United States Food

and Drug Administration. This is one way consumer leverage can be

applied to GlaxoSmithKline; eventually this official documentation

will compel the company to fully disclose the " adverse side effects "

of Paxil. You can report your side effects at: MedWatch.

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