Cholesterol drug Zocor (simvastatin) may cause muscle damage and potentially lethal kidney damage at its highest dosage, according to new warnings released by the Food and Drug Administration.
Regulators released a statement on Wednesday noting that patients taking the 80 milligram dose of Zocor, a popular statin drug, have a higher risk of muscle damage (myopathy) when compared to patients taking lower doses of the drug or comparable medications. The warning also applies to generic versions of the drug. Zocor is prescribed, along with a healthy diet and exercise, to lower the low-density lipoprotein, or LDL, cholesterol, commonly referred to as "bad cholesterol."
About 60 percent of those that experience myopathy were genetically predispositioned to the condition--though a rare form of myopathy called rhabdomyolysis can damage the kidneys and lead to potentially fatal kidney failure.
The 80 milligram dose should be discontinued by all patients except those that have been taking it for more than a year without any signs of injury or debilitating side effects. New patients are advised to start on a lower dose, according to a statement released on the agency's web site.
Over 2.1 million patients in the United States received a prescription for the drug (manufactured by Merck) or one of its generic equivalents last year, according to the FDA.
