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ZYPREXA: THE ISSUES SURROUNDING THE LAWSUITS

August 5 2006 at 1:18 PM
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Response to And BUSH's Mental Illness Screening Squad are still on the Move

http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html

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Zyprexa Lawsuit, Risperdal Lawsuit; Seroquel Lawsuit;
Explanation of the issues (and sequence of events) surrounding the lawsuits that claim that the use of Seroquel, Zyprexa and  Risperdal caused health problems such as pancreatitis and diabetes and stroke
.
 

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About the author:
Jerrold S. Parker Esq limits his practice to cases regarding drug and medical device liability.  He has  most recently appointed to the Plaintiff's Steering Committee in the Zyprexa Products Liability Litigation (MDL # 1596). He makes frequent appearances on television shows such as Court TV and Good Day New York
See Also: YourLawyer.com; extensive database of data and case-law regarding drug liability actions including Crestor, Zyprexa, Accutane, Prem Pro, etc.
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Atypical Anti-Psychotic Drug Lawsuits


Zyprexa (
Olanzapine®) Lawsuit

Zyprexa, like Risperdal and Seroquel, has been associated with serious side effects in patients, especially those who have already been diagnosed with diabetes

Knowledge of the potential dangers of Zyprexa were discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug. 

One of these cases resulted in a patient's death due to necrotizing pancreatitis, a very serious condition in which cells in the pancreas die.

An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. 

It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug. 

In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and the other Atypical Antipsychotics with respect to their connection to cases of Type 2 Diabetes ( sometimes called "adult onset diabetes").

The authors of the Wall Street Journal article  estimated that somewhere around 11 million people have taken Zyprexa. An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died.

In addition to the Wall Street Journal article, five lawsuits were filed against Eli Lilly and Co. accusing the company of failing to warn Zyprexa patients of the risk that Zyprexa caused the patients' diabetes. 

The plaintiffs are seeking damages of up to $35 million.  In order to confront the charges, Lilly sponsored two patient trials and opened its files of Zyprexa patients to an outside researcher to study the issue. 

The lawsuits claim that Lilly knew that the product was dangerous and unsafe and that it never took the necessary steps to provide this critical information to medical professionals or patients.

Finally, in May of 2003 forty reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.

In March of 2004, Eli Lilly ( the company that markets Zyprexa in the United States) sent a so call "Dear Doctor Letter" to thousands of physicians who were likely to use Zyprexa. 

The letter indicated that Lilly was adding a warning statement to the Zyprexa label regarding the increased risk of hyperglycemia and diabetes in people taking Zyprexa and similar medicines. [ Click Here to read the actual warning letter ]


Would you like to see more information regarding Zyprexa?



Risperdal (Risperidone)  Lawsuit

Risperdal, which is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson, is another member of the family of drugs knows as  Atypical Antipsychotics. 

Risperdal has been linked to diabetes and, more specifically, Type 2 diabetes. (Type 2 diabetes is sometimes called adult-onset diabetes.  Type 2 diabetes is associated with an increased risk of heart disease and stroke)

Other serious side effects, however, include Neuroleptic Malignant Syndrome (NMS), Tardive Dyskinesia, stroke or stroke-like events, and even death.  (NMS is a potentially fatal syndrome involving muscle rigidity, and irregular blood pressure and pulse). 

Tardive Dyskinesia is a central nervous system disorder, which results in involuntary movement of the limbs and twitching of the face and tongue.)

Although it is primarily used for treating schizophrenia, Risperdal is also used to control other behavioral disorders in elderly patients ( such as nursing home patients) who have delusions, aggression, and anxiety as is often seen in patients with Alzheimer's disease and/or dementia.

Risperdal has also been under scrutiny for causing severe side effects and adverse reactions mentioned above. 

Although Risperdal was approved by the FDA in 1994, it took some time before the dangerous side effects were completely identified though a series of studies.

On April 11th of 2003 Johnson & Johnson sent "Dear Doctor" letters to thousands of physicians in the United States advising them of the possible risk of stroke among elderly patients taking Risperdal.

The letter indicated that Johnson and Johnson had modified the Risperdal label so that practitioners were aware that:

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" there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis " [ Click Here to read the actual  Risperdal "Dear Practitioner letter" ]. 

This came after Johnson & Johnson had received 37 reports of stroke or related events like blood clots or hemorrhages, including 16 deaths. 

As a result of these findings, Johnson & Johnson updated the warning label on Risperdal to include more specific information about strokes in the elderly.  At this time it became apparent that Risperdal should not be used to treat dementia because there is no evidence that it is safe or effective in that capacity.

Risperdal has also been known to cause irregular headaches, muscle weakness and spasms, high fever, constipation, weight gain, and headaches.   

People on Risperdal who have any or all of these side effects should contact their doctor and discuss these problems with their doctor because these conditions may be warning signs of serious illness.

Would you like to see more information regarding Risperdal?


Seroquel (Quetiapine Fumarate ) Lawsuit

Seroquel, manufactured by AstraZeneca, is an oral medication used to manage the symptoms associated with schizophrenia such as delusions, thought disorder, hallucinations, social withdrawal, lack of energy, apathy, and reduced ability to express emotion.

The drug, which was approved by the FDA for marketing in 1997, affects a broad range of neurotransmitter receptors, including serotonin receptors.  It is  also sometimes used to treat the mania associated with bipolar disorder.

News of Seroquel's side effects and emerged as a result of observational data released at a medical conference in Philadelphia which showed that patients on Seroquel had 3.34 times as many cases of diabetes as those on older antipsychotics such as haldoperidol. 

Towards the end of August, 2003, news of side effects associated with Seroquel became widely publicized and caused the value of AstraZeneca's stock to decrease by almost one percent. 

Soon after, the law firms of Parker & Waichman and Aylstock, Witkens & Sasser announced that a class action lawsuit had been commenced in the United States District Court for the Middle District of Florida on behalf of all those who had used Seroquel. 

This lawsuit contends that AstraZeneca was aware that Seroquel was associated with  a high occurrence of diabetes, but they did not take steps to adequately warn doctors or patients in the United States of this potential risk.

The pending lawsuit seeks statutory, exemplary and punitive financial damages from AstraZeneca for their alleged disregard of the well being and health of the plaintiffs and class members (the people who took Seroquel and subsequently developed diabetes). 

In addition, the lawsuit also alleges that AstraZeneca aggressively marketed and promoted Seroquel for "off label" use that was beyond its FDA approved indications at the time in question.

AstraZeneca is accused of unfairly offering incentives to doctors and other medical professionals in an effort to increase the number of Seroquel prescriptions that were written. 

The Seroquel class action lawsuit seeks to establish a medical monitoring fund to pay for anyone who has taken Seroquel so that they can be tested for diabetes and other blood sugar disorders.

On January 30th, 2004, AstraZeneca Pharmaceuticals LP, the company that markets Seroquel in the United States sent a "Dear Doctor" letter to thousands of doctors throughout the USA.  The letter indicated that:

"...Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Seroquel."  [ Click Here to read the actual Seroquel "Dear Doctor" letter]

Would you like to see more information regarding Seroquel?


CONCLUSION

Seroquel, Risperdal, and Zyprexa (as well as other atypical antipsychotics such as Clozapine or Clozaril) are drugs with the potential to cause dangerous side effects which should not be overlooked and should be taken very seriously. 

The issue of these risks has become more pressing as the drugs are now being prescribed for adults with milder medical conditions and children who may better off taking different drugs that are not associated with side effects such as pancreatitis, stroke and Type 2 diabetes. 

As with any drug, the critical consideration is whether the  benefits of taking these drugs outweigh the potentially dangerous side effects, the rate of adverse incidents reported, and the cost of the drugs themselves.

The option of prescribing older, less risky conventional antipsychotic drugs is also a consideration. 

Another factor which must be taken into account is the strong connection between diabetes and schizophrenia which has been noted and studied by scientists since the 1920s. 

Patients with schizophrenia and other forms of mental illnesses develop diabetes at a rate up to four times higher than the general population, whether they are on anti-psychotics or not. 

This is due to the fact that people with schizophrenia often display many of the risk factors associated with diabetes such as a sedentary lifestyle, a lack of good medical care, a poor diet, and a high rate of obesity.

The research surrounding Seroquel, Ripserdal, and Zyprexa is still developing.

It is the opinion of many physicians that although people with schizophrenia and other serious mental illnesses are already at a greater risk of developing diabetes.

However, if a patient did not have diabetes before being prescribed an atypical antipsychotic  such as Zyprexa, Risperdal, Seroquel, and developed symptoms shortly after beginning a regimen on any of the above medications, then it is possible that the drug may responsible for their deteriorating physical health.

Appendix

Here is a bibliography regarding items published ( from trustworthy sources) that lawyers (on both sides of the issue) sometimes refer to when they are trying to build a case against Zyprexa, Risperdal or Seroquel:

http://neuropsychiatryreviews.com/may01/npr_may01_diabetes.html
[ 5/2001; 816 words ] Report of a presentation at a conference of psychiatrists.  Cites 2 small trials (with a total of 126 patients) where a link to atypical antipsychotic medications is thought to have occurred.  This is not actual research but a paper where the author suggests that there may be a problem and that more work is needed.

http://www.healthyplace.com/Communities/Thought_Disorders/schizo/news/diabetes_antipsychotics_2.htm
[4/22/03] Derivative work of a Wall Street Journal Report; mentions upcoming study using veterans at test subjects; also has detailed background information on atypical antipsychotic drugs possible link to weight gain and diabetes.

http://diabetes.about.com/library/blnews/blnantipsychotics503.htm
[ 5/2003; 1,150 words ] Press release attributed to the University of Buffalo; The bottom line regarding this report is that the authors feel that diabetes is related to the mental condition that the drugs treat, not the drugs themselves.  The authors feel that diabetes goes hand-in hand with psychiatric disorders such as schizophrenia and bipolar disease and that the drugs may be blamed falsely.

http://ajp.psychiatryonline.org/cgi/content/abstract/159/4/561
[ April, 2002; 4,275 words] American Journal Of Psychiatry; results of a  retrospective analysis of a large number of VA Hospital patients who received clozapine, olanzapine, risperidone, or quetiapine.   
See Also> JNJ Press Release; indicates that the strongest association of diabetes and use of atypical agents was for people less than age 40; use of risperdal was associated with a lower incidence of diabetes than the other drugs in people aged 40-49.  The authors discuss possible statistical flaws their study and back off from saying that the drugs caused diabetes; The say diabetes was associated with taking these drugs not necessarily caused by them.

http://www.psychiatrist.com/pcc/pccpdf/v05n01/v05n0103.pdf
Primary Care Companion J Clin Psychiatry [ 01/03; 9 pages severalthousand words] The authors of this report examine 70 scientific papers, trials, case reports, etc and analyse the data scientifically.  They conclude that there is not sufficient evidence to blame the increases in diabetes with atypical antipsychotics.

*************
About the author: Jerrold S. Parker Esq. limits his practice to cases regarding drug and medical device liability.  He has  most recently appointed to the Plaintiff's Steering Committee in the Zyprexa Products Liability Litigation (MDL # 1596). He makes frequent appearances on television shows such as Court TV and Good Day New York. 
See Also: YourLawyer.com; extensive database of data and case-law regarding drug liability actions including Crestor, Zyprexa, Accutane, Prem Pro, etc.
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  • Australia - parents questioning Zyprexa denied access to son by psych Graham Burrows - admin on Aug 14, 2006
    1. AUSTRALIA - Melbourne's own TeenScreen effort,, ORYGEN - PUSHERS TO SCHOOLS - admin on Aug 15, 2006
    2. Australia Melbourne: ORYGEN & Psychiatrists dabble in 'scientific' schizophrenia research - admin on Aug 15, 2006
    3. UK: Reminder - 'TEENSCREEN FOR INFANTS' UK version, helped by pharma front groups - admin on Aug 18, 2006
     


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