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Diabetes Drug - Rezulin - Banned by the FDA
Mar 22, 2000 -- The diabetes drug Rezulin (troglitazone), prescribed
for adult-onset diabetes, was withdrawn from the market on Tuesday
following a request from the U.S. Food and Drug Administration
(FDA). A spokesperson for the FDA said that the drug, which lowers
blood sugar in diabetics, has been linked to 63 deaths and 90
confirmed cases of liver failure. There are 15 million Americans
who suffer from adult-onset diabetes.
Sidney Wolfe,
M.D., director of the Public Citizen Health Research Group,
said
the Rezulin "should have been gone a long time ago.
The British government took it off the market a long time ago.
The question is why did it take the FDA so long to take it off
the market. Its just another example of how low the standards
have gotten at FDA," Wolfe said. If the agency had acted earlier,
some of these patients would still be alive.
Top officials of the FDA were publicly warned by their own expert
epidemiologist in March 1999, that every patient taking Rezulin
for diabetes was at risk of sudden liver failure and that no
reliable way existed to protect them. But FDA officials decided
to keep Rezulin on the market anyway.
The FDA made Rezulin among the fasted-approved prescription
drugs in this decade. Critics now claim that the FDA has become
too responsive to drug manufacturers by rushing to approve risky,
non-essential medications.
On March 15, 2000, Public Citizen urged the FDA to initiate
a criminal investigation of Warner-Lambert, the manufacturer
of Rezulin. The group said that it had learned from a member
of the clinical investigating team of physicians that the Warner-Lambert
failed to notify the FDA of liver toxicity among patients in
the original clinical studies until after the drug had received
approval.
In a statement
issued on Tuesday night, Warner-Lambert said that it had voluntarily
withdrawn the drug from the market, although
it "continues to believe that the benefits of the drug outweigh
its associated risks."
The company added, ``repeated media reports sensationalizing
the risks associated with
Rezulin therapy have created an environment in which patients
and physicians are simply unable to make well-informed decisions
regarding the safety and efficacy of Rezulin.''
Both the
FDA and Warner-Lambert urged patients to "not discontinue
taking Rezulin or other treatments for diabetes without discussing
alternative therapies with their physicians."
Dr. Janet
Woodcock, director of the FDA's Center for Drug Evaluation
and Research,
said, "...safety data from Rezulin as compared
to similar, alternative diabetes drugs indicate that continued
use of Rezulin now poses an unacceptable risk to patients.''
According
to the FDA, Actos, which is sold by Eli Lilly in the US, and
SmithKline
Beecham's Avandia, both of which were approved
last year, "offer the same benefits as Rezulin without the same
risk."
Rezulin has generated sales of $1.7 billion, but Warner-Lambert
expected sales to fall by 47% to only $400 million this year
due to safety concerns. At its height there were 1 million patients
taking Rezulin. There are currently about 500,000 patients still
taking Rezulin. Hopefully, they hear the news. If you have a
loved one with diabetes, please tell them and tell them to seek
a natural alternative. I wouldn’t trust Actos or
Avandia either.
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