As a result of these reports, Bayer requested from the FDA a change in cerivastatin’s U.S. labeling to include a bolded counterindication for prescription with gemfibrozil in May of 1999, more
visible to consumers and physicians than the earlier warning.
approved in December of 1999.
In early 1999, there appeared
little indication that cerivastatin rate than any other statin.
to be a higher
In May 1999, Bayer received FDA approval for a 0.4mg dosage. Because it was more potent, this higher dosage allowed Bayer to compete
more directly with other statins.
The 0.4mg dose became the one most
By the second quarter of 2000, Bayer had
increased its overall share of six percent (Angelmar, 2007).
In July of 1999, the clinical trial of the 1.6 dosage of
cerivastatin incidence of
had to be discontinued because of
dosage approved was dropped and the not published (Psaty et al., 2004).
the very high (12%) effort to get the 1.6mg the clinical trial were
By late 1999, spontaneous reports suggested that cerivastatin (in the approved dosages) was associated with a 2-6 cases of rhabdomyolysis
per 100,000 patient than the occurrence 2004).
While fairly low, this was ten times higher
In July of 2000, the .8 dosage of cerivastatin was approved by the
FDA, despite increasing signs that cerivastatin was riskier than other
Beginning in late 2000 and early 2001, it became clear that
cerivastatin caused rhabdomyolysis at significantly higher rate than
worldwide there had six month
between September 2000 and February 2001.
been eight periods.
fatalities and two fatalities in the preceding two At first, Bayer reacted by urging doctors to start