The consumer advocacy group Public Citizen, in a petition filed with the Food and Drug Administration, is seeking a ban on the drug.
Crestor is in the popular family of cholesterol-lowering drugs called statins. It won approval FDA 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.
In studies, Crestor also was linked to some cases of kidney abnormalities not seen with other statins.
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 mg. to 10 mg, and said patients should never exceed 40 mg.
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 Public Citizen.
Among the records:
Crestor maker AstraZeneca wouldn't comment on the deaths or other serious side effects except to say "the safety profile is totally comparable" to what pre-marketing studies had predicted, said spokesman Gary Bruell.
"We're very pleased with the performance of the drug thus far," he said, noting that 1 million patients worldwide have tried Crestor, including 600,000 in the United States. The company is about to begin major television advertising for the drug.
But Wolfe contended that Crestor "has no unique advantage, but some unique risks" over other statins. He told the FDA there is growing concern about the drug, citing two major U.S. insurers who refuse to pay for it because of the muscle risk and a recent recommendation against use by Sweden's drug advisers.