Group Seeks Ban on Cholesterol Drug

Maker, FDA deny charges that Crestor causes kidney damage

TUESDAY, May 18, 2004 (HealthDayNews) -- The watchdog group Public Citizen is once again calling for the U.S. government to ban Crestor, a statin drug recently approved to lower cholesterol.

Since the original petition was filed with the U.S. Food and Drug Administration in early March, the group said, 11 additional cases of muscle damage, 10 of them in the United States, and three additional cases of kidney problems, all in the United States, have been reported.

"Our [initial] petition was based on data through the end of February and, in a matter of six more weeks, these cases are starting to pour into the FDA," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "There was one case in the U.S. in the original petition. Now there are 10 more certain and the eleventh is not clear. It's beginning to go off the charts. This is up there with Baycol."

Baycol is another statin whose maker, Bayer Corp., voluntarily removed it from the market in 2001 because of reports of sometimes fatal rhabdomyolysis, the same muscle reaction referred to in Public Citizen's petition.

Both Crestor's maker, AstraZeneca, and the FDA are denying any similarities to Baycol, however. "At the present, there is absolutely no indication of a pattern of risk in any way similar to what was seen with Baycol," said FDA spokesman Jason Brodsky.

According to Public Citizen, seven of the additional cases of rhabdomyolysis were in people taking the low dose of 10 milligrams, while three were in people taking the next lowest dose of 20 milligrams. Five of the eight U.S. patients whose ages were known were under 50, and nine of the American patients had to be hospitalized. Public Citizen also reported that a 39-year-old woman in the United States had died of complications from the drug.

The FDA, however, doesn't see anything unusual in reports that have been made. "There have been close to a million U.S. prescriptions for Crestor and, amongst those, we do have reports of rhabdomyolysis -- both U.S. and non-U.S. -- but we have those as well for all commonly prescribed statins," Brodsky said. "Other reports related to Crestor are few and are not definitely tied to Crestor use as opposed to something attributable to the underlying disease."

Wolfe, however, has not been impressed with the FDA's responses thus far. "The FDA doesn't know what it's talking about," he said. "For them to say that there may be other explanations is preposterous. No other statins cause primary renal failure. The FDA deals very poorly with these things."

The drug's maker, obviously, is siding with the FDA. "The claims made by Public Citizen are misleading and are based on inappropriate interpretation of data," said Gary Bruell, a spokesman for AstraZeneca. "Wolfe's views of Crestor are well known and haven't changed since before approval, despite continuous evolution of a large volume of data which supports our and regulator's views that Crestor has a favorable benefit-risk profile."

Muscle toxicity, Bruell added, is a recognized reaction seen with all statins, which can lead to rhabdomyolysis in rare cases. "The reports have been very, very rare, less than one in 10,000 -- or less than 0.01 percent -- and these reports are often associated with confounding factors," he continued. "There are no confirmed reports of death at all attributed to Crestor. That is patently false."

More information

For more on statins, visit the American Heart Association or the National Institutes of Health.

SOURCES: Sidney Wolfe, M.D., director, Public Citizen Health Research Group, Washington, D.C.; Gary Bruell, spokesman, AstraZeneca, Wilmington, Del.; Jason Brodsky, spokesman, U.S. Food and Drug Administration, Rockville, Md.
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