Zoloft and Suicide

August 26, 2002

Below is the latest issue of Kohls Preventative Psychiatry newsletter.

Kohls is a physician living in Minnesota. You can reach Dr. Kohls by e-mail at:

gkohls@.... -Rick Seattlehttp://rjgiombetti.blogspot.com

Preventive Psychiatry E-Newsletter recipients: Editions 9, 10 and 11 are taken

verbatim from the following website <www.Zoloft-Side-Effects-Lawyer.com>.

Despite their having been written by and/or for a legal firm who has been

representing plaintiffs in cases against the makers of Zoloft, I have found the

writings exceedingly accurate and documentable, and they make a very strong case

for the prosecution. I am using them because, in my opinion, they are accurate

and I couldn't have done a better job of writing them myself. The statements

can, in general, be applied to the other SSRIs. Admittedly, this information is

very sobering, but affirms most of my long-held suspicions about the SSRIs.

Politically speaking, the threat to the pharmaceutical industry is huge, and it

will filter down to the psychiatrists and primary care physicians who were

deceived by the advertising from those companies over these 12 years of the

" Prozac experiment. " It will be interesting to see how this all plays out if

and when this information gets the attention it deserves in the media. .

If anyone wishes to have their address removed from this list, simply reply and

write " REMOVE " ZOLOFT AND SUICIDE

Zoloft causes some people (3-5%) to experience a suicidal event. Such events are

marked by: 1) suicidal thoughts 2) suicidal gestures (typically cutting of the

body) 3) suicide attempts 4) actual death by suicide. Pfizer, like the other

SSRI manufacturers, has long been aware that SSRIs can cause people to kill

themselves.

The issue of SSRI-induced suicidality first came to the public’s attention in

February, 1990 when two prominent Harvard researchers and psychiatrists, Drs.

Teicher and 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. Healy, a prominent psychopharmacologist in Wales, England, 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. A. King, was also

looking into the problem of SSRI-induced suicidality in1991, 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.”

Pfizer also successfully diverted attention away from problems caused by

Zoloft-induced suicidality in the pediatric population initially raised by the

FDA. On March 19, 1996, the FDA wrote Pfizer:

We note that there appears to be an increase frequency of reports of suicidality

in the pediatric/adolescent patients exposed to sertraline compared to either

placebo or sertraline-treated OCD patients. If this is in fact the case what

would be a plausible explanation.

In response Pfizer, on May 28, 1996, submitted a report to the FDA entitled

“Suicide-Related Behavior in Children and Adolescents Sertraline OCD Clinical

Development Program.” In this report, Pfizer acknowledged that one of the

clinical investigators attributed a young patient’s suicidal gesture to Zoloft,

but argued that the suicide events seen in the clinical studies were at or below

that occurring in a depressed population. This argument was disingenuous for two

reasons: 1) the population being studied was not a “depressed” population, and

2) Pfizer compared the 2.7% of pediatric patients who experienced a suicide

event during the clinical trials (which lasted less than 3 months) to the

national average of 2.7% which was created over a period of one year. A correct

analysis reveals that the number of suicide events occurring during the

pediatric clinical trials was in fact four (4) times the national average!

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 involved Zoloft as well as the other SSRIs and

demonstrated a statistically significant relative risk of 5.5 for all SSRI

antidepressants, and a 4.9 relative risk for Zoloft specifically.

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. 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 Pfizer’s protestations to the contrary, it is generally recognized that

SSRIs, including Zoloft, can cause suicidality. Not only is this reflected in

the current DSM IV TR, it appears, repeatedly, elsewhere. For example, though

Pfizer can control what is published in the Physicians’ Desk Reference (“PDR”)

because it pays for it, the family edition is not so controlled. The PDR Family

Guide to Prescription Drugs, under “Zoloft” contains the following language:

“Zoloft may also cause mental or emotional symptoms such as: Abnormal dreams or

thoughts, aggressiveness, exaggerated feeling of well-being, depersonalization

(“unreal feeling”), hallucinations, impaired concentration, memory loss,

paranoia, rapid mood shifts, suicidal thoughts, tooth-grinding, worsened

depression.”

(See also nurse’s PDR Resource center publication. Bold in original.)

Similar information can be found in Dr. Opler’s Prozac and Other

Psychiatric Drugs, Everything You Need to Know, Pocket Books, 1996. In this

book, under “Side Effects of Sertraline,” it states:

“Sertraline also may cause mental or emotional side effects including abnormal

dreams or thoughts, aggressiveness, apathy, delusions, depersonalization (a

feeling of unreality), euphoria, hallucinations, memory loss, paranoia, rapid

mood swings, suicidal thoughts or attempted suicide, teeth grinding, and

worsened depression”

In the most recent edition (2001) of Clinician’s Handbook of Prescription Drugs

by Dr. Seymour Ehrenpreis, Former Chairman and Professor Emeritus of

Pharmacology, Chicago Medical School, under “Sertraline, Adverse Reactions,” it

lists: “Serious: urticaria, suicidal tendencies, hepatitis, bronchospasm,

psychosis.” (emphasis added)

Though people in other countries are not adequately warned of the suicide risk

caused by Zoloft, they do get better information than those in the United

States. One example is the French label for Zoloft. It states:

“As with any antidepressant treatment, there is still a risk of suicide in

depressed patients at the treatment initiation with loss of psychomotor

inhibition possibly preceding the antidepressant action itself”

Another is the label for Zoloft in Sweden:

“In depressed patients, the possibility of a suicide attempt remains during

treatment until remission has occurred and could, in certain instances, also

increase initially as the inhibition decreases before the mood is improved.”

(Emphasis added.)

In Germany, physicians in that country are instructed to closely monitor their

patients they put on Zoloft. The German label states:

“Since the possibility of a suicide attempt is inherent in depression and may

persist until significant remission occurs, patients should be closely monitored

during the early course of therapy and until the onset of the antidepressant

effect. As Zoloft has no general sedating effects a generally sedating drug may

additionally be required in patients with agitation and marked insomnia.”

This last sentence is particularly important because as can be seen from the

next section, many of the people who experience Zoloft-induced suicidality,

first experience a state of extreme agitation medically known as akathisia (see

Extreme Agitation).

In a recent court case, a jury found that the SSRI 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. kline 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: SKB - 80%, Don Schell

- 20%. 4) Damages - $8,000,000.

In the criminal context (See Zoloft and Hostility and aggression), the Supreme

Court New South Wales ruled on May 24, 2001 that a man’s ingestion of Zoloft

caused him to murder his wife, Regina v. Hawkins [2000] NSWSC 420.

If you, or someone you know, have been the unfortunate victim of this kind of

side effect from Zoloft, please report it immediately to the Federal Food and

Drug Administration (“FDA”). This is very important for this one way pressure

can be put on Pfizer, Inc. to fully disclose the adverse side effects of Zoloft.

You can report your side effects at: http://www.fda.gov/medwatch/

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August 26, 2002