- The Washington Times - Monday, May 23, 2005

DALLAS (AP) — Side effects with Crestor, a cholesterol-lowering drug that consumer advocates tried to get off the market earlier this year, occur more often than indicated by a government study, a new analysis shows.

The review of leading cholesterol drugs taken by millions of Americans showed that most are very safe and that the risk of serious problems, even with Crestor, is very low. But the latest research seemed to challenge a Food and Drug Administration decision related to the drug’s safety.

In March, the FDA had contended Crestor’s risks were no greater than its competitors, and it rejected consumer advocacy efforts to have the drug, made by AstraZeneca PLC, pulled from the market.

Instead, the FDA ordered a warning on the label, saying Crestor could cause serious muscle problems and kidney damage, especially among Asians.

“This will be further reason to take the drug off the market,” said Dr. Sidney Wolfe, director the consumer advocacy group Public Citizen. He said his group would try again to get the drug off the market.

An estimated 20 million Americans take drugs called statins, which researchers say are still the best drugs for lowering cholesterol and reducing the risk of heart disease and stroke.

Many of the drugs cause muscle problems among some people, but experts advise patients to talk to their doctors about lowering their dosage, which can solve the problem.

For the study, published online yesterday by the American Heart Association’s journal Circulation, researchers analyzed reports of side effects sent to the FDA for Crestor and compared them to the rates during the same time period for three other statins: Lipitor, Zocor and Pravachol.

“What we’ve shown is that amongst this family of drugs, Crestor has a poorer safety profile, but that the overall rate of adverse effects is still quite low,” said study leader Dr. Richard Karas, director of the preventive cardiology at Tufts-New England Medical Center in Boston.

Dr. Karas said that people who should consider taking Crestor are those unable to lower their cholesterol enough with other drugs or those who may be allergic to other drugs.

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