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toxicologist did note in internal discussions that .4mg was the highest daily dose that should be developed for clinical use because the dose

response curve of cerivastatin was steeper than that of other statins. Nonetheless, the risk of rhabdomyolysis was one of many listed in the warnings section in the insert that accompanied the U.S. prescribing information for all statins.

7

Clinical trials, however, are poor instruments for detecting rare adverse effects because the relatively small numbers involved make it

difficult to observe rare events rhabdomyolysis was detected more

(Farmer, 2001). frequently after 8

As a result, the statins had

been

approved and used more widely from doctors and hospitals submitting reports of adverse events to the FDA (“spontaneous reports”).

The situation was complicated by the common co-prescription and

concurrent use of fibrates and statins. drugs used to control high cholesterol.

Fibrates are another class of But prescribing statins at the

same time as fibrates substantially increases the risk of

rhabdomyolysis.

During

the

development

of

cerivastatin

this

effect

and

the risk of rhabdomyolysis was thought control by monitoring of CK levels and

to be rare and suitable for muscle pain (Lau, 2001).

the .2 and .3

dosages under

the trade name

professionals

over the next

year indicated

Cerivastatin was released in the United States in February 1998 at

Baycol.

Reports by

that

rhabdomyolysis

medical sometimes

occurred, usually when the patient was also taking the fibrate

gemfibrozil. cholesterol.

These

drugs

were

often

prescribed

together

to

counter

high

____________

7 Letter by Professor Dr. Schuluter, Professor Kühlmann and Dr. Ziegler, Bayer AG Geschhäftsbereich Pharma, Forschung und Entwicklung Medizin und Entwicklung, Wuppertal, Germany to Dr. MacCarthy MILES INC, Pharmaceutical Division, West Haven, Conn. 2/8/91. Halton v. Bayer Corp. 699 L Plaintiffs’ Exhibits.

8 Some have concluded that the post-release monitoring of adverse events and spontaneous reports by federal regulatory agencies needs to be increased (Farmer, 2001).

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