Group Seeks Ban on Cholesterol Drug

May 19, 2004

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... The watchdog group Public Citizen is once again calling for the U.S.

government to ban Crestor, a statin drug recently approved to lower

cholesterol.

Since the original petition was filed with the U.S. Food and Drug

Administration in early March, the group said, 11 additional cases of muscle

damage, 10 of them in the United States, and three additional cases of

kidney problems, all in the United States, have been reported...

Baycol is another statin whose maker, Bayer Corp., voluntarily removed it

from the market in 2001 because of reports of sometimes fatal

rhabdomyolysis, the same muscle reaction referred to in Public Citizen's

petition...

.... seven of the additional cases of rhabdomyolysis were in people taking

the low dose of 10 milligrams, while three were in people taking the next

lowest dose of 20 milligrams. Five of the eight U.S. patients whose ages

were known were under 50, and nine of the American patients had to be

hospitalized. Public Citizen also reported that a 39-year-old woman in the

United States had died of complications from the drug....

Muscle toxicity, Bruell added, is a recognized reaction seen with all

statins, which can lead to rhabdomyolysis in rare cases. " The reports have

been very, very rare, less than one in 10,000 -- or less than 0.01 percent

-- and these reports are often associated with confounding factors, " he

continued. " There are no confirmed reports of death at all attributed to

Crestor. That is patently false. "

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