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Drug Safety

Warning issued on use of cholesterol drug Crestor by Asians

Published in Medicine and Law Weekly, March 25th, 2005

The cholesterol drug Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-Americans and some other patients.

The U.S. Food and Drug Administration (FDA) said March 2, 2005, that Crestor, like other drugs in the category known as statins, can have a rare side effect of serious muscle damage.

A clinical trial found that levels of Crestor in Asian patients were double those of Caucasians taking the same dose, increasing the chance of muscle damage.

The new label urges physicians to start Asian patients, people with severe kidney disease and patients taking cyclosporine at the lowest dose...

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