Zoloft and Suicide
The Food and Drug Administration is currently reviewing a British study showing that the antidepressant Zoloft may induce suicidal behavior. In the study, 10% of the participants, who had no prior history of depression, became dangerously suicidal while on Zoloft. Although this study has helped expose the dangerous effects of Zoloft, had it not been for a deliberate cover up by Pfizer, Zoloft's manufacturer, these dangerous effects would have been known a long time ago.
As early as 1990 prominent researchers and psychiatrists, both in the US and abroad, have been publishing articles reporting that the class of drugs to which Zoloft belongs SSRIs (selective serotonin reuptake inhibitors) increase the potential for suicidal behavior in patients. When the FDA finally reacted to the reports in 1996 they sent a letter to Pfizer asking for an explanation. Pfizer drafted a report entitled "Suicide- Related Behavior in Children and Adolescents Sertratine OCD Clinical Development Program". The report argued that the incidents of suicides seen in patients taking Zoloft was consistent with the incidents of suicides seen in a depressed population.
At the time, the FDA accepted the explanation, unaware that Pfizer was deliberately being deceitful: the studies had not been conducted on a depressed population but like the current studies, on a population that had no history of clinical depression. Further, Pfizer was comparing a yearly national average (2.7%) to an average gleaned in a three month study. Had the study gone on longer it is likely that the average would have increased to more closely resemble the 10% seen in the British study.
Even before 1990, there were warnings that SSRI could induce suicidal behavior. Shortly after its approval in 1987, researchers discovered that between 3 to 5 % of Zoloft patients developed akathisia, a severe agitation that doctors believe may lead to suicidal and homicidal fantasy. However, Pfizer never mentions this very serious possible side effect on Zoloft's labels.
The first public report pointing to the suicide tendencies seen in some people taking SSRI, was published in February, 1990 by Drs. Martin Tiecher and Johnathan Cole and was entitled: "Emergence of Intense Suicidal Preoccupation During Fluoxetine (Prozac) Treatment". The article detailed clinical studies in which a small but notable percentage of the participants taking Prozac experienced suicide thoughts.
When suicide tendencies first emerged in patient using SSRIs, it was often reasoned to be the result of the SSRIs increasing energy levels before the antidepressant effect of the drug had a chance to take effect. This lag was thought to create a brief period in which a depressed person suddenly had enough energy to act on existing suicide tendencies before the anti-depressant eliminated these desires. However, in 1991, Dr. David Healy, a well known British psychopharmacologist, who had also noticed the suicidal tendencies developing in patients taking SSRIs, published a report entitled "Antidepressant Induced Suicidal Ideation." In the report Dr. Healy concluded that suicide thoughts "may in some instances be produced by the antidepressant" itself rather than as a result of "a lifting of psychomotor retardation" as was previously thought.
Through out the 90's there where numerous reports published by prominent psychiatrist, psychopharmacologists, and researchers based on thorough clinical studies that found SSRIs to causes extreme agitation, suicidal tendencies, and aggressive behavior in some people. The following are two prominent examples:
"Serotonin and Suicidality: The Impact of Fluoxetine Administration II. Acute Neurological Effects" A report publish by Yale psychiatrist Dr. Robert King in 1995, and based on clinical studies conducted on children and adolescents 10 to 17 years old, concluded that SSRIs may induce suicidal behavior among a "poorly defined" group of people.
"Deliberate Self-Harm and Antidepressant Drugs: Investigation of a Possible Link," was a report conducted by Dr. Stuart Donovan based on a large clinical study that found that persons with no history of depression taking SSRIs are five and a half times more likely to develop suicide tendencies than persons who are not.
So conclusive was the evidence established in the various reports published in the 90's that it is now widely accepted in the medical community that SSRIs cause suicidal behavior in some people. The only people that still deny this are people who have a financial interest in denying it. i.e. Drug companies and their advocates.
Should SSRIs have been approved?
In fact, it can be safely said that if what is known now (about the link between suicide and SSRIs) were known in the late 80's, SSRIs never would have been approved by the Food and Drug Administration. The SSRIs were approved on flawed clinical trials that did not test for SSRI induced suicide thoughts. The researchers conducting these initial trials never asked participants whether or not they experienced suicidal feelings or restless agitation (akathisia). Than, in subsequent trials, if patients reported suicidal feelings, it was recorded as a symptom of their already existing depression.
Perhaps the most damning indication that these initial clinical trials were inadequate is found in the opinions of the ten member FDA panel that originally cleared the drugs for use based on these trials. Seven of the 10 have said that, in light of the new findings, they would have reconsidered their decision.
Despite more and more instances of suicide tendencies being found in people using SSRIs , only recently have regulatory bodies started to make changes. For instance in June of this year, the FDA made its first move to regulate SSRIs declaring that doctors should no longer prescribe the SSRI Paxil to patients under 18 years of age. The recommendation was based on data from several clinical studies showing that suicidal fantasy and attempts were common in children who used Paxil. The belated recommendation was unprecedented, but as the link between suicide and SSRIs becomes more obvious, it is inevitable that the FDA will have to become increasingly more stringent.
Courts have also become sensitive to the dangers of the Zoloft "family" of drugs. In 2000 a Wyoming man who had only recently started taking Paxil killed his wife, daughter and grand daughter and than himself. The surviving family sued GlaxoSmithkKline and was compensated 8 Million when the jury found that there wasn't enough evidence to conclude that Paxil was primarily responsible for the behavior. David Healy, a leading expert on SSRIs and key expert in the case, sited a study in which an astonishing 25% of healthy participants taking Seroxat, an SSRI similar to Zoloft, became 'disturbingly agitated'. Currently there are numerous cases pending in which suicidal or homicidal behavior has been linked to the use of SSRIs and the Wyoming decision will likely have a positive influence on their outcomes. The verdict, however, is not good news for SSRI makers like Pfizer.
In summary, Pfizer has suppressed information about the suicide inducing effect of their product, to make a vast profit selling treatments that they don't understand for a serious illness they also don't understand. The result is that their product may be causing many more problems than solving. Some of which have and will be fatal. If you or some one else you know has suffered a loss because of Pfizer's negligence, please contact us to learn your legal rights. You are not alone.
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