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Public Citizen Seeks Cholesterol Drug Ban

May 17, 2004 | AP

A consumer advocate is urging the government to ban the new anti-cholesterol drug Crestor, citing new cases of a life-threatening muscle side effect among patients taking a low dose thought to minimize the risk.

Public Citizen's renewed call comes days after Crestor's maker, AstraZeneca, wrote doctors in Britain urging them to start patients on a mere 10-milligram dose because of concern about that muscle-destroying condition, rhabdomyolysis.

Food and Drug Administration records show 11 cases of the muscle condition reported to the agency since late February, on top of 14 previously known - and seven of those newest patients were taking the 10-mg dose, said Sidney Wolfe of Public Citizen.

Nine of the new cases required hospitalization; at least five were under age 50, he said.

Crestor "is a doomed drug," Wolfe wrote the FDA. "We renew our effort to get the FDA to ban this uniquely dangerous drug before it does any further damage."

FDA spokesman Brad Stone said the agency is closely monitoring Crestor. He said, however, that many of the side-effect cases reported so far are among patients with other risks for the muscle problem.

"So far, what we've seen doesn't indicate a disturbing pattern, but we'll continue to look at the data" from Wolfe and other sources, Stone said Monday.

A spokesman for AstraZeneca said the drug's safety "is totally consistent" with competitors in the popular cholesterol-lowering statin family.

Crestor was approved last August, although seven cases of rhabdomyolysis had occurred in patients taking an 80-mg dose during studies.

Rhabdomyolysis is caused by a breakdown in muscle fibers that end up circulated in the body. Those fibers can be toxic for kidneys and can cause them to fail.

The condition, characterized by muscle pain and weakness, is very rare. It prompted another statin, Baycol, to be pulled off the market in 2001 after dozens of deaths worldwide.

But FDA ultimately declared Crestor an important option for some patients because it appeared slightly more potent than other statins. To lower the side-effect risk, the agency recommended starting doses of 5 mg to 10 mg, and warned never to exceed 40 mg.

Wolfe initially urged a Crestor ban in March, citing seven more rhabdomyolysis cases in the drug's first months of sales, including a 39-year-old American who died after taking a 20-mg dose.

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