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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.

This was

approved in December of 1999.

In early 1999, there appeared

little indication that cerivastatin rate than any other statin.

caused

rhabdomyolysis

at

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

commonly prescribed.

By the second quarter of 2000, Bayer had

substantially approximately

increased its overall share of six percent (Angelmar, 2007).

the

statin

market

to

In July of 1999, the clinical trial of the 1.6 dosage of

cerivastatin incidence of

had to be discontinued because of

CK

elevation

among

patients.

The

dosage approved was dropped and the not published (Psaty et al., 2004).

results

of

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).

years.

While fairly low, this was ten times higher

of

rhabdomyolysis

with

other

statins

(Psaty

et

al.

In July of 2000, the .8 dosage of cerivastatin was approved by the

FDA, despite increasing signs that cerivastatin was riskier than other

statins.

Beginning in late 2000 and early 2001, it became clear that

cerivastatin caused rhabdomyolysis at significantly higher rate than

other

statins.

Eighteen

cases

of

fatal

rhabdomyolysis

were

reported

worldwide there had six month

between September 2000 and February 2001.

By comparison,

been eight periods.

fatalities and two fatalities in the preceding two At first, Bayer reacted by urging doctors to start

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