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Group asks for ban of drug Crestor

By wire services
Published March 5, 2004

A 39-year-old woman has died of a muscle-destroying condition linked to the controversial new anticholesterol drug Crestor, a consumer advocate said Thursday, citing 16 cases of serious side effects in urging a ban of the drug.

Crestor is in the popular family of cholesterol-lowering drugs called statins.

It won Food and Drug Administration approval in August, after a delay because of safety concerns: Seven cases of the potentially fatal, muscle-destroying condition called rhabdomyolysis occurred during studies involving patients on an 80-milligram dose. For that rare condition to pop up in clinical trials was unusual - and particularly worrisome since another statin, Baycol, had been pulled off the market in 2001, linked to dozens of rhabdomyolysis-caused deaths worldwide.

Still, the FDA ultimately decided to approve Crestor, saying it appeared to be slightly more potent than other statins and thus may be important for some patients. To lower the risk of side effects, FDA recommended starting doses of 5 to 10 milligrams and said patients should never exceed 40 milligrams.

But records from the FDA and health agencies in Canada and Britain show life-threatening side effects occur even at those lower doses, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, in a petition filed with FDA Thursday seeking a ban.

Hybrid mosquitoes blamed for U.S. West Nile spread

West Nile virus has set up housekeeping in the United States so readily because of a hybrid mosquito species that transmits the disease by biting both people and birds.

But the disease has not taken hold in northern Europe, where the infection is limited mainly to bird-biters, a new study suggests.

The first case of West Nile virus detected in the Western Hemisphere was in the New York City area, in 1999. Since then, the virus has infected humans in 45 states.

Most of the time, "you must have a mosquito that bites a bird today and a human tomorrow for transmission to occur," said Dina Fonseca, a genetic researcher with the Smithsonian Institution's Museum of Natural History. She is the lead author of the new study, published today in the journal Science.

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