Cholesterol Drug Crestor Produces More Side Effects

But the statin's benefits outweigh risks, heart experts conclude

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HealthDay Reporter

MONDAY, May 23, 2005 (HealthDay News) -- Crestor, the newest and most powerful of the cholesterol-lowering statin medications, also has a higher rate of adverse side effects than other members of this family of drugs, American Heart Association experts reported Monday.

A review of reports filed with the U. S. Food and Drug Administration's monitoring system indicate that the rate of adverse side effects for Crestor (rosuvastatin) was more than twice that of Zocor (simvastatin) and six times higher than either Lipitor (atorvastatin) or Pravachol (pravastatin), Dr. Richard H. Karas, lead author of a report in the heart association journal Circulation, said at a telephone press conference held Monday.

Still, Crestor has a much lower rate of adverse side effects than Baycol, the statin removed from the market in 2001 after the FDA received numerous reports of severe muscle and kidney damage in patients using the drug.

Two themes were stressed by the cardiologists who took part in the press conference. One was that people should not stop taking statins -- including Crestor -- because of the report.

"Our work confirms multiple previous studies which show that, as a family, these are safe medicines to use," said Karas, director of the Preventive Cardiology Center and the Women's Heart Center at Tufts-New England Medical Center in Boston.

"Statins in general are very safe drugs and can be life-saving to high-risk patients," added Dr. Scott Grundy, director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center in Dallas, and author of an editorial accompanying the journal report.

Like many other drugs, however, "statins can have serious side effects," Grundy said. "I urge physicians to be familiar with this list of adverse effects and use statins cautiously."

A second theme was the inadequacy of the FDA's drug safety monitoring system. It has many weaknesses, Karas said. One is that doctors are not required to report all the drugs that patients take, which makes it difficult to single out the exact cause of a specific adverse effect should one occur.

Karas stressed, however, that available data suggests the risk of damage for those on Crestor is low. There were 145 reports of muscle or kidney complications during the drug's first 12 months on the market, with over 5.2 million prescriptions written that year. That works out to a risk of one in 35,862, Karas noted.

"For individuals already taking Crestor, I would tell them not to be alarmed," he said. "They should talk to their physicians and see if they should be on this drug in light of this information. If they are able to achieve their cholesterol goals with other medications, it might be preferable."

Karas said he would continue to prescribe Crestor for a select group of patients: those with high cholesterol levels not satisfactorily reduced by another statin. While use of Crestor does seem to carry a higher risk of adverse events than other statins, it also tends to bring about a more powerful cholesterol-lowering effect, he pointed out.

Grundy noted that Public Citizen, a Washington, D.C.-based non-profit consumer advocacy group, officially petitioned the FDA to take Crestor off the market in March. The FDA denied the group's request, but required the drug to carry a revised warning label to emphasize the risk of muscle damage. At the time, Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said that "once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug's maker, AstraZeneca, instead of the public."

In response to Monday's research, Wolfe said, "This will be further reason to take the drug off the market." He said his group would try again to get the drug banned, according to the Associated Press.

Some participants in the press conference acknowledged ties with the drug industry. Karas said he is on the AstraZeneca speaker's panel, while Grundy noted similar ties to several companies that market statin medications.

More information

Questions about cholesterol and statin therapy are answered by the American Heart Association

SOURCES: Richard H. Karas, M.D., director, Preventive Cardiology Center, Tufts-New England Medical Center, Boston; Scott Grundy, M.D., Ph.D, director, Center for Human Nutrition, University of Texas Southwestern Medical Center, Dallas; May 23, 2005, Circulation

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