FDA Zoloft data

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

At issue beyond a Charlsteon, SC court, is whether Christopher Pittman—who was 12 years old and under the influence of Zoloft, a powerful psychotropic drug, when he killed his grandparents–should have been charged with murder and tried as a competent adult? Or, whether he should have been charged with manslaughter for the crime committed by a (possibly) deranged, 12 year old?

FindLaw columnist, attorney Elaine Cassel, discusses the broader issues that this case raises.

“the Pittman case is an indictment of both our medical system and our legal system — supposedly both the world’s finest. Our medical system let a 12-year-old down when it allowed a doctor to legally prescribe for him a drug that may well have caused him to have hallucinations and delusions-including the delusion that he heard voices commanding him to commit horrific crimes.”

“Our legal system now is letting a fifteen-year-old down by pretending that he is what he plainly is not: an adult. This toxic combination suggests that it is not just Pittman, but society, that may be in need of a cure.”

Both the drug safety oversight agency (FDA) and the medical / mental health establishment failed to meet their professional and public responsibility. They failed to ensure that the drugs prescribed for a 12 year old do not have hidden hazards that may trigger violent behavior. Evidence of the potential hazards of SSRI antidepressants is contained in the results from company controlled clinical trials, published case reports–and in FDA’s database of adverse drug reports filed with FDA’s MedWatch.

AHRP requested an epidemiologist who has access to FDA’s Medwatch database through June 2004, to search for Zoloft.

Using FDA’s preferred terminology to describe aggression, hostility and violent behavior, the following reports were filed*

Aggression………………… 303 reports

Homicie ideation………….. 34 reports

Hostility ……………………372 reports

Irritability …………………169 reports

Paranoia …………………. 189 reports

Personality disorder……….225 reports

* It is unknown whether each or several reported effects refer to a different individual.

When one considers that only 1% to 10% of adverse events are reported to the FDA, and millions of people are on the drug, there are potentially thousands of hostile, aggressive, even homicidal individuals who pose a threat to themselves and others.

Until March 22, 2004, these serious adverse drug effects have not been disclosed to prescribing physicians or the public although instances of these adverse effects occurred during clinical trials and were known to these drugs’ manufacturers. When the public got wind about evidence of these drugs’ potential harm, the FDA responded by issuing long-overdue label warnings—including a Black Box warning about the increased risk of suicidal behavior in children.

On March 22, 2004, the FDA has required the label of Zoloft and the other antidepressants in the SSRI and SNRI class to include warnings about:

“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… as well as the emergence of suicidality in adult and pediatric patients being treated for major depressive disorder and other indications both psychiatric an nonpsychiatric.”

Pfizer continues to deny the scientific evidence demonstrating that Zoloft poses safety hazards as described in the FDA-approved label. See: Pfizer’s statement about the Pittman case: http://www.courttv.com/trials/pittman/docs/pfizerstatement.html

Others who continue to deny the risks posed by SSRI antidepressants are primarily stakeholders in the psychotropic drug industry who are financially indebted to these drugs’ manufacturers. First among the deniers of the scientific evidence, marching in step with Pfizer and the other SSRI drug manufacturers, is the American Psychiatric Associaion whose position has undermined its professional credibility.

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