On March
21, 2000 the 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 actual number of deaths is estimated
to be as many as ten times higher than the reported 63 cases.
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.
The recall
came after an FDA whistleblower shared his findings and internal
FDA email messages with a L.A. Times reporter. This information
and interviews with several doctors led to a series of articles
in the Los Angeles Times discussing the dangers of Rezulin. The
articles also raised questions about the FDA's irregular "fast
track" approval of the drug.
