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Published: Sunday, 5/29/2005

Fading faith in Crestor

A new study raises questions again about the safety of the cholesterol-lowering drug Crestor. But the Food and Drug Administration doesn't appear to be in any hurry to take it off the market, and the Tufts University study's authors, oddly enough, have not sided with critics who want it pulled.

That's baffling, given that the study, sponsored and published by the American Heart Association and published in its online journal, Circulation, found that patients taking Crestor have from two to eight times more kidney problems and severe muscle weakness than patients taking other drugs that fight cholesterol.

This isn't the first indication of problems with Crestor. In March, when the FDA dismissed consumer calls to take the drug off the market, the federal agency only ordered Crestor to carry warning labels stating that it could cause serious muscle problems and kidney damage, especially among patients of Asian ancestry.

The research leader, Dr. Richard Karas, said "Crestor has a poorer safety profile" compared to other drugs, called statins, that fight cholesterol - Lipitor, Zocor, and Pravachol.

But the scientists are not demanding that it be taken off the market. Supporters of Crestor, which became available in 2003, say its patients had fewer problems than those who took Baycol, a statin pulled from the market in 2001.

Patients shouldn't have to experience devastating health problems before the FDA takes a drug off the market. Of the 20 million Americans who take statins, complications are more commonly found among patients taking Crestor.

That should at least alarm somebody at the FDA to take a closer look. Nobody should have to put themselves at risk if indeed safer medications are out there.

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