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Published on 22 March 2010

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FDA warns over cholesterol drug


A drug that is prescribed to people with high cholesterol could lead to muscle damage and in extreme cases may cause severe and potentially lethal kidney problems, the US Food and Drug Administration has said.

The agency said the greatest chance of these side-effects occur when Zocor is taken in high doses. The top FDA-approved dose is 80 milligrams.

Even at lower dosage levels it is known that statin drugs like Zocor can cause muscle damage in some patients, but as the amount taken increases other side-effects include rhabdomyolysis, a form of muscle damage that can lead to kidney damage or failure, and death.

Zocor is the brand name for the drug used by Merck. Its chemical name is simvastatin.

Simvastatin, which is also part of Merck’s cholesterol drug Vytorin and Abbott Laboratories’ drug Simcor, is sold by 11 other generic drug makers including Dr Reddy’s Laboratories, Teva Pharmaceutical Industries, and Novartis’ Sandoz division.

FDA-approved doses of Zocor range from five milligrams to 80 milligrams.

The FDA said the warning is based on clinical trials, studies, reports of side-effects by users and prescription data.

Copyright Press Association 2010

Food and Drug Administration

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