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Rezulin,
a prescription medication used to treat diabetes, first
gained prominence in June 1996, when the
National Institutes of
Health announced a $150 million clinical study to test the
medication's effectiveness.
Warner-Lambert marketed Rezulin
aggressively, and priced it at nearly three times the cost of
appropriate treatments by other medications. It touted Rezulin
as "the first anti-diabetes drug designed to target insulin
resistance." That statement prompted the
FDA to accuse
Warner-Lambert of making "false and misleading"
claims, and to recommend that the company "immediately
discontinue" circulating new releases containing the claim.
Warner-Lambert described Rezulin
as a medication with breakthrough effectiveness, and "Side
Effects Comparable to Placebo." The company allegedly made this
statement while knowing that its own clinical trial data showed Rezulin
users were three to six times more likely to suffer liver injury
than patients taking the placebo.
By July 1997, seven people receiving Rezulin
had died from the same side effects that Warner-Lambert had observed
in its pre-market Rezulin
tests. By the fall of 1997, the FDA began to receive reports of Rezulin
patients suffering serious liver injuries, including death following
liver failure.
On March 21, 2000, Warner-Lambert withdrew Rezulin
from the U.S. market. The withdrawal was at the request of the FDA,
which had concluded that "continued use of Rezulin
now poses an unacceptable risk to patients." Since then, the
FDA has acknowledged reports of liver damage occurring after
patients were taken off the medication, which indicates that the
risk of harm does not disappear with the withdrawal of the drug. If
you have taken Rezulin and have experienced liver problems, contact
your doctor and/or an attorney, as you might have a claim against
the manufacturer.
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