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Rezulin Litigation FAQ's
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| Q: |
Why
Was Rezulin Withdrawn From The Market On March 21, 2000? |
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| A:
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Warner
Lambert's diabetes drug Rezulin was withdrawn from the market on March
21, 2000 for safety reasons. Citizen advocate groups had petitioned
the United States Food and Drug Administration as early as July 1998.
The withdrawal was the
culmination of Warner Lambert's failed efforts to keep Rezulin on
the market even after receiving reports of death and liver injuries
among Rezulin users.
After receiving at least
35 reports of liver injuries in Rezulin patients, Warner Lambert
announced a label change on November 3, 1997. Rezulin was banned
in Great Britain on December 1, 1997.
By March 1999, the FDA
estimated that more than 400 Rezulin patients had suffered liver
damage.
On March 21, 2000, the
FDA requested that Warner-Lambert withdraw Rezulin from the market.
The FDA noted that Rezulin was more toxic than the two alternatives
to Rezulin, Avandia and Actos. In the wake of the withdrawal, previously
concealed adverse information regarding Rezulin has emerged.
Dr. Neal Kaplowitz, a liver
specialist and former Warner-Lambert consultant said: "I think
as I look back at it retrospectively, there was a problem from the
very get-go, in terms of propensity to cause liver problems."
Dr. David J. Graham, the
FDA's senior epidemiologist, has estimated that 20 Rezulin patients
a month are suffering from liver failure.
The FDA is now investigating
whether Warner-Lambert concealed findings of liver toxicity in 1994
clinical trials.
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| Q: |
How
Serious Are The Problems Experienced By Rezulin Users? |
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| A:
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An FDA
study has found:
| 1. |
An estimated
430 or more Rezulin patients have suffered liver failure; |
| 2. |
Rezulin
users' risk of liver failure is increased 1200 times by taking
Rezulin; |
| 3. |
One of
every 1800 Rezulin patients could suffer liver failure; |
| 4. |
Regular
liver monitoring is no guarantee of safety because Rezulin can
quickly and unpredictably attack the liver. |
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| Q: |
What
Type Of Side Effects Have Rezulin Users Experienced? |
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| A: |
In
the early stages of liver damage in Rezulin patients, symptoms of
liver damage may be difficult to detect. In later stages, the symptoms
may include yellow eyes, abdominal pain, nausea, clay colored stools
and dark urine. In rare cases, Rezulin patients have suffered severe
liver damage resulting in death or liver transplant surgery.
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| Q: |
Do
Rezulin Users Have A Right To Be Compensated For Any Health Problems
Caused By Rezulin? |
| A:
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If
Rezulin has caused you or a loved one significant physical damage,
you may be entitled to a large compensatory award. You must protect
those legal rights before they lapse by passage of time and are
barred by various states' statutes of limitations. You should contact
an attorney to evaluate your rights. Many valuable legal rights
are lost everyday because of people's failure to take legal precautions.
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| Q: |
What is Rezulin
(troglitazone)? |
| A:
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Rezulin, the
brand name for troglitazone, is an antihyperglycemic agent. It helps
your body respond better to insulin and it reduces the amount of
sugar produced by your liver. It can help control blood sugar levels.
Rezulin can be taken by itself, or in combination with other medication.
It is the second "insulin sensitizing" drug. The first
was Glucophage (metformin). Rezulin was approved by the U.S. Food
and Drug Administration (FDA) in 1997
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| Q: |
What is Rezulin
used for? |
| A: |
IRezulin
is used to treat non-insulin-dependent diabetes mellitus (Type II
diabetes), along with diet and exercise, and insulin, a sulfonylurea,
or metformin (Glucophage) if necessary.
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| Q: |
Who is prescribed
Rezulin? |
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| A:
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Rezulin was prescribed
for Type II, or adult onset, diabetes patients who had not responded
to other therapies. Type II diabetes develops when the body no longer
responds to insulin, a hormone required to process sugar in the
blood. Doctors hailed Rezulin because it promised treatment for
patients who failed other therapies. Untreated diabetes can cause
heart and kidney failure, blindness and other problems.
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| Q: |
What are the problems
with Rezulin? |
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| A:
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In some cases,
Rezulin has caused severe liver damage resulting in death or liver
transplant. If you develop nausea, vomiting, abdominal pain, unusual
fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored
stools, or dark urine, notify your doctor immediately. These symptoms
may be early signs of liver damage. Your doctor will need to monitor
your liver function with blood tests before starting treatment with
Rezulin, every month for the first year of treatment, and every
3 months (quarterly) thereafter.
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| Q: |
Who should not
take Rezulin? |
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| A:
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No one should
take Rezulin without first talking to a doctor, especially if you
have liver disease. Before taking this medication, you should tell
your doctor if you have kidney disease, heart failure, thyroid disease,
Type I diabetes mellitus (insulin-dependent diabetes) or need surgery.
You may need a lower dose or special monitoring during treatment
if you have any of the conditions listed above.
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| Q: |
What is the status
of Rezulin? |
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| A: |
On March 21,
2000, following discussions with the FDA, Parke-Davis (a division
of Warner-Lambert Company) voluntarily discontinued the sale and
distribution of Rezulin. Parke-Davis withdrew it from the market
on the advice of the FDA.
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| Q: |
What
should you do if you're taking Rezulin? |
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| A:
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The most important
thing for you to know about this withdrawal is that you should not
stop taking your Rezulin without first consulting with your doctor
-- to do otherwise may seriously complicate your diabetes treatment
and endanger your health. After you have consulted with your doctor
to decide which alternative therapy would be best for you, Parke-Davis
will provide you with a full refund of the price you paid for your
current supply of Rezulin.
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