NEW YORK (AP) – The Food and Drug Administration said the highest available dose of Zocor, a component in cholesterol drugs, can cause muscle damage as well as severe and potentially lethal kidney damage.
The agency said statin drugs like Zocor are known to cause muscle damage in some patients, but the risk is more severe when patients are taking 80 milligram doses of Zocor, which is the highest FDA-approved dose.
The 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 & Co. of Whitehouse Station, N.J. 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 5 milligrams to 80 milligrams.
The FDA said the warning is based on clinical trials, studies, reports of side effects by users and prescription data.
Date: March 19, 2010
Source: Associated Press
