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*************
About the author: Jerrold S. Parker Esq limits his practice to cases regard
ing 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 regard
ing drug liability actions including Crestor, Zyprexa, Accutane, Prem Pro, etc.
********************
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 r
esult 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?
Recently Published News On Zyprexa ; updated in real time from Google
Official Website how Zyprexa works, side effects, warnings, etc.
Prescribing Information -- PDF File; this is what the doctor goes by
Prescribing Information Source B - HTML; RxList.com
Patient Information
Scientific Literature Search ( Medline)
General Information - side effects, warnings, precautions, picture of pill
Zyprexa FDA Database Search; Zyprexa (Sorted by date)
See Also: Atypical Antipsychotic Drug Information
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:
… " 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?
Recently Published News On Risperdal ; updated in real time from Google
Official Website - Patient info, Prescribing info, info on schizophrenia
Prescribing Information- PDF File
Prescribing Information Source B - HTML; RxList.com
Patient Information
Scientific Literature Search (Medline)
General Information- side effects, warnings, picture of pill.
FDA Database; Risperdal (Sorted by date)
JNJ Press Release [10/24/02] Risperdal associated with lowered incidence of diabetes [ click here to read the study that this press release refers to ]
See Also: Atypical Antipsychotic Drug Information Database
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?
Recently Published News On Seroquel ; updated in real time from Google
Official Website portal; consumer and professional information
Official prescribing Information- PDF File; this is what the doctor goes by when he makes the decision to prescribe Seroquel.
Prescribing Information Source B - HTML; RxList.com
Patient Information; Medline Plus; National Institutes of Health
Scientific Literature Search ( Medline)
General Information - side effects, warnings, precautions, picture of pill
FDA Database; Seroquel (Sorted by date)
See Also: Atypical Antipsychotic Drug Information
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 several
thousand 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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