The evidence, however, is clear,
these medicines are not
linked with suicide,
these medicines are not
linked with an increased rate of self harm.
Suppressed Paxil Suicide Data Released
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Paxil Suicides: Legal Help
The FACT is GlaxoSmithKline, like the other SSRI manufacturers, has long been aware that SSRIs can cause people to kill themselves. Such events are marked by:
Suicidal gestures (typically cutting of the body)
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: “ [I]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:
Don Schell: 20%
4) Damages: $8,000,000
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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.