Rezulin Liver Damage
The FDA approved Rezulin in January 1997. Warner-Lambert
made $2.1 billion in sales before the Rezulin recall was issued
in March 2000. Suspected of causing 391 deaths, including hundreds
Rezulin liver damage cases, the manufacturer has found themselves
in the middle of countless Rezulin lawsuits and investigations.
|An FDA study found:
-An estimated 430 or more Rezulin patients have suffered liver
-Rezulin patients have an increased risk of 1,200 times of having
a liver failure due to the diabetes drug use.
-One out of every 1,800 Rezulin patients could suffer a liver failure,
and at the time of the Rezulin recall there had been an estimated
2 million Rezulin patients.
-Despite the FDAs instructions and numerous Rezulin label
updates for regular liver monitoring, getting liver tests does
not guarantee a patients safety because Rezulin can attack
the liver without warning.
|Rezulin Liver Damage
Warner-Lambert, Rezulin manufacturer had downplayed the Rezulin
liver damage concerns when seeking federal approval by assuring
the FDA that the diabetes drug risk was low. FDA officials gave Warner-
Lambert inside information and favors during Rezulins development
according to documents from the company and government. Although the
company found the risks of Rezulin to be outweighed by the benefits,
Warner-Lambert knew as early as 1993 of the potentially life threatening
Rezulin liver damage.
Vice president of diabetes
research at Warner-Lambert, Dr. Randall W. Whitcomb told the Endocrine
and Metabolic Drugs Advisory Committee of the FDA in December 1996
that the liver damage incidence was comparable to placebo. At the
time the company had known at least 12 people had suffered serious
cases of Rezulin liver damage during clinical trials. In reality,
though, the placebo studies were not comparable to Rezulin patients.
Just 0.6% of the placebo pills suffered liver problems opposed to
2.2% of the Rezulin liver damage patients. When asked about this
discrepancy after the Rezulin recall, Whitcomb claimed the numbers
were not all that different.
|Despite all these risks, Rezulin was still
chosen to go through a speedy approval because it was viewed as a
breakthrough in diabetes drug. In just six months Rezulin was FDA
approved, a vast difference between the usual years that it takes.
A consultant to Warner-Lambert that helped conduct two of their studies,
Dr. Janet B. McGill, alleged in a letter sent to Senator Edward Kennedy
that Rezulin manufacturer deliberately omitted reports of liver
toxicity and misrepresented serious adverse events experienced by
patients in their clinical studies.
Warner-Lambert, now owned by Pfizer Inc, is now trying to defend
against the hundreds of Rezulin lawsuits that have emerged due to
the serious Rezulin
liver damage and heart damage effects. Contact
us to speak with an expert Rezulin liver damage lawyer.
|Heart Damage Cover
Rezulin was approved on the fast track in 1997, but links to at least
56 cases of heart failure and 90 cases of liver failure ended up sparking
a debate over Congress demand for speedy reviews of new prescription
drugs. Previously undisclosed documents and interviews showed that
Rezulin heart defects were also a concern from the beginning. Rezulin
was FDA approved in just six months, which did not allow a complete
clinical trial to determine if Rezulin caused heart damage. Instead,
the Echo Study was put together to determine whether the use of Rezulin
for 48 weeks would result in a change in the left ventricle. A left
ventricle change would indicate heart failure because it can result
if it cannot contract forcefully enough.
Paresh Dandona, the endocrinologist who served as Warner-Lamberts
principal investigator for the Echo study in Buffalo, said, The
Echo Study was not properly conducted, according to the standard
protocol. I was not made aware of the fact that the patients from
this site, in particular, for whatever reason, whether it was due
to technique or whatever, that they had increased left ventricular
mass, (L.A. Times, 3-26-00). Dadona also added that he had
delegated a majority of the work to heart specialists that had deviated
from the Echo Study procedures when studying up to one third of
the Rezulin patients.
As far back as October 18, 1996, concern was raised over the safety
of Rezulin in regards to its potential for adverse
heart effects. Dr. Robert I. Misbin, an FDA diabetes specialist,
wrote an email to a former FDA medical officer who had studied Rezulin
in the 1990s and recommended its rejection, Dr. John L. Gueriguian,
saying, my primary concern about Rezulin is related to its
potential for cardiac toxicity, (L.A. Times, 3-26-00). Many
diabetes patients, an estimated 15 million Americans, are overweight
and have a far higher risk of developing congestive heart failure,
which made the issue of the use of Rezulin and its potential to
cause heart problems especially important.
After the FDA approval of Rezulin on January 29, 1997, officials
had negotiated a nonbonding pledge from Warner-Lambert to start
a new study to assess Rezulins effect on patients who had
preexisting heart disease evidence. Few patients were enrolled,
and this study was never completed. Rezulin patients did die of
heart failure, but doctors claimed many of these patients had preexisting
heart problems. Guston Turner, a pharmacist from the FDAs
scientific investigations division had found inconsistencies in
research measuring Rezulins effect on the heart. Turner felt
that the FDA should have delayed approval of Rezulin until
all the questions were addressed, (L.A. Times, 3-26-00).
Serious, life-threatening Rezulin
side effects have been directly linked to the use of the diabetes
drug. Warner-Lambert has been blamed in dozens of deaths from liver
failure and thousands of other Rezulin liver damage cases from 1997-2000.
us to speak directly with an expert Rezulin liver damage lawyer.
A 1998 Public Citizen survey found the FDA
could require manufacturers to conduct phase IV studies as a condition
of approval. According to the reports, at least one phase IV study
was required for 195 of 306 new drugs approved by the FDA during
the 1990s, but just 11 of the 195 Phase IV studies had been completed.
This pertains to the safety of Rezulin because a complete clinical
trial was not completed prior to the FDA approval of the diabetes
drug due to the "fast track" method used on the drug.
After Rezulin was approved, official negotiated a nonbonding pledge
from Warner-Lambert to start a new study to assess Rezulin's effect
on patients who had preexisting heart disease evidence. Few patients
were enrolled, and this study was never completed.