The Food and Drug Administration says the highest available dose of the cholesterol drug Zocor can cause muscle damage as well as severe and potentially lethal kidney damage.
The agency says 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. The risks include rhabdomyolysis, a form of muscle damage that can lead to kidney damage or failure, and death.
Zocor, or simvastatin, is sold by Merck and Co. Merck's cholesterol drug Vytorin and Abbott Laboratories' drug Simcor also contain simvastatin.
The FDA says the warning is based on clinical trials, studies, reports of side effects by users and prescription data.