Advocacy Group Seeks Ban Of Cholesterol Drug
Crestor Receives Government Approval In August
POSTED: 3:11 pm CST March 4, 2004
WASHINGTON -- Public Citizen, the consumer advocacy group, is calling for a ban on Crestor, the new anticholesterol drug. The group cites 16 cases of serious side effects.
Crestor is part of a family of cholesterol-lowering drugs called statins. Among the reasons for the requested ban is the death of a 39-year-old woman from kidney failure and rhabdomyolysis, a muscle-destroying condition, both linked to the drug.Before the drug won government approval last August, studies turned up seven cases of that condition involving patients on an 80-milligram dose. In addition, Crestor was linked to some cases of kidney abnormalities not seen with other statins.Both side effects are listed on the Food and Drug Administration's consumer information page on the drug."The FDA should never have approved this drug in the face of such serious and potentially lethal adverse effects," said Dr. Sidney Wolfe, of Public Citizen. "The only way the agency can show it has concern for patient safety, and not drug industry wishes, is to pull Crestor from market immediately."AstraZeneca, the company that makes Crestor, refused comment on any side effects, saying the safety profile is totally comparable to what premarketing studies had predicted.
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