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Study, FDA Differ On Cholesterol Drug Crestor

May 24, 2005 | Washington Post

The powerful cholesterol-lowering drug Crestor is significantly more likely than other statins to cause muscle deterioration that can lead to kidney disease and failure, according to a study in the American Heart Association's journal, Circulation.

The conclusion is at odds with the most recent recommendation of the Food and Drug Administration, which in March rejected a petition to remove Crestor from the market. At the time, the FDA said Crestor appeared to be no more dangerous than other statins for most people.

Based on the number of side effects reported to the FDA, however, the researchers said yesterday that Crestor was two to six times as likely to cause complications over a 1-year period as three other statins on the market.

Although the number of serious side effects reported by Crestor users was small, the new findings suggest that the drug, whose generic name is rosuvastatin, probably should be reserved for patients who have a hard time lowering their overall cholesterol levels with other statins, said Dr. Richard Karas of the Tufts-New England Medical Center in Boston, who led the study.

Crestor's maker, AstraZeneca, defended its billion-dollar-a-year drug, saying, "We strongly disagree with the conclusions of this study." In a statement, the company said the FDA's voluntary system for soliciting reports of complications, called "adverse events," does not confirm the accuracy of the accounts it gets and so cannot be used to determine a drug's risks.

Sidney Wolfe of Public Citizen Health Research Group, who filed the petition rejected by the FDA, said the study confirmed his conclusions.

"This should be very embarrassing to the FDA," said Wolfe, whose group may try again to get the drug off the market.

But FDA spokeswoman Laura Alvey said that the new analysis yielded no new information. "We haven't found any convincing evidence that Crestor poses any more of a risk than the other statins," she said.

Doctors participating in a teleconference set up by the American Heart Association, which funded the study, said patients should not stop taking statins but should discuss any problems with their doctors.

"Statins in general are very safe drugs and they can be life-saving to high-risk patients," said Dr. Scott Grundy of the University of Texas Southwestern Medical Center in Dallas.

Both Karas and Grundy have received research contracts and speaking fees from statin makers, including AstraZeneca. The heart association also receives considerable financial support from drug companies.

Crestor is the most potent statin on the market. Its higher strength, however, does not make a dramatic difference in studies. While statins such as Lipitor, Zocor and Pravachol lower LDL or harmful cholesterol by 50 to 55 percent, Crestor decreases it by 55 to 60 percent, said Grundy and Karas.