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On March 21, 2000 head of the FDA's
center for Drug evaluation and Research stated that the "Continued use of
Rezulin" posed an "unacceptable risk " to diabetes patients. At
least 63 Rezulin users have died of liver failure. The total number of deaths is
estimated to be as many as ten times higher than the reported 63 cases.
Doctors prescribed Rezulin to
diabetics who took insulin but whose blood sugar was not well controlled. It was
designed to help insulin (either your own or injected) work better, by drawing
the sugar from your blood into the cells to supply energy.
The drug was approved for diabetics
who:
- Used insulin
- Took certain types of oral
antihyperglycemic medications or fodiabetics
- Could no longer be controlled by diet and
exercise alone.
Rezulin was banned in England in
December 1997, following the death of an American who took the drug. The drug
manufacturer, Warner-Lambert successfully fought a ban in the U.S. for 27 months
before the FDA decided to prohibit sales of the drug on March 21, 2000.
Before the ban, sales of Rezulin
generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was
prescribed 488,000 times in January of 1999. 63 Rezulin users have reportedly
died from use of the drug. The deaths were caused by liver failure. The total
number of deaths is likely to exceed 63 by many times according to experts.
FDA Drug Safety Report
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