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
liver damage cases, Rezulin 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 was seen as a miracle
pill to treat the 15 million Americans that suffer Type-2
diabetes. First marketed as a once a day pill, Rezulin allowed
some Type-2 diabetes sufferers to halt insulin injections. On March
21, 2000, per the FDA's request, Warner-Lambert finally issued the
Rezulin recall after its controversial
run on the U.S. market. The Rezulin manufacturer soon found themselves
in the middle of civil lawsuits and criminal and congressional investigations.
Currently, Warner-Lambert is still trying to settle the numerous lawsuits
brought against them for the large number of liver damage Rezulin
caused, as well as
heart problems after an estimated 2 million people took Rezulin.
A liver specialist and former Warner-Lambert consultant said of Rezulin,
"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."
Warner-Lambert knew of at least 12 people that had suffered from Rezulin
damage as early as 1993, but they continued to downplay the potentially
life threatening conditions by assuring the diabetes drug was low
Breaking News - SEPTEMBER
May Be Getting Harder to Fight Off
New findings published in the Mayo clinic Proceedings show
that diabetes drugs may cause heart failure and cause fluid
buildup in some patients. The first drug in the newest class
of diabetes drugs was Rezulin. In March 2000 regulators
found the drug to pose such a great risk of adverse effects
that a Rezulin recall was issued. Full
More Rezulin Lawsuit News......
Public Citizen director, Dr. Sidney Wolfe, finds Rezulin to be
an example of the dangerous practice the FDA uses of, "approving
drugs too readily and waiting too long to remove them. It makes
some people lose faith in the FDA. It also winds up killing a lot
of people that wouldn't have been killed had the drugs not been
put on the market in the first place."
you, or someone you love, has suffered the side effects of Rezulin,
contact us to speak with a Rezulin Lawyer!
A Rezulin Recall Newsletter has been
created to provide extensive information regarding the entire Rezulin
recall and the deadly and serious side effects associated to the diabetes
drug. In addition, information on Type-2
diabetes and alternate ways to treat the disease is included.
information can also be found on this site to allow Rezulin patients
to speak directly to an expert Rezulin lawyer.
Under 50: 12
80 and older: 17
Note: Some victims' ages were not provided
1st six weeks: 20 deaths
Note: Rezulin on the market for nine months in 1997
Source: Times analysis of FDA records
described by Public Citizens Dr. Sidney Wolfe as one
of the most dangerous drugs on the market, was finally removed
from the U.S. market on March 21, 2000. The diabetes drug, first
removed by the British government back in December of 1997, was
not removed in the U.S. because FDA officials claimed they were
waiting to be sure two newer diabetes
drugs were safer. Wolfe thinks, It is just another example
of how low the standards have gotten at FDA. Rezulin was approved
on the FDAs fast track which allows a breakthrough
drug to go through the approval process in just six months. The
diabetes drug was well received because it was the only drug that
restored the bodys sensitivity to insulin. Despite reports
liver failure Rezulin patients experienced directly following
the drugs approval, the FDA allowed Rezulin to stay on the
market and instead simply ordered Warner-Lambert to strengthen the
liver toxicity warnings on Rezulins
label. After 63 people died as a result of liver failure the
director of the FDAs Center for Drug Evaluation and Research,
Dr. Janet Woodcock finally stated, continued use of Rezulin
now poses an unacceptable risk to patients. An estimated 2
million people used Rezulin.
A health policy man at George Washington University in Washington
D.C., Thomas Moore, wonders, Should we have relatively dangerous
drugs and simply warn people that they might kill or seriously injure
them? click here to read more about
Rezulin label >
Rezulin was created to treat type-two diabetes, which accounts
for over 80% of diabetes cases. click
here to read more about diabetes >
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 liver failure and heart damage effects.
click here to read more >
Resource links for further education on the events and medical
implications surrounding the recalled drug Rezulin.
here for Rezulin links>
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.