The U.S. Food and Drug Administration (FDA) warned patients and healthcare providers that higher doses of the cholesterol-lowering drug Zocor, sold generically as simvastatin, carries an increased risk of muscle injury, according to new data.
Additionally, the agency warns that mixing Zocor with certain other medications can increase patients’ risk of muscle injury. While all statins carry a risk of muscle injury (myopathy), in rare cases, it can progress to a more severe form of muscle injury called rhabdomyolysis, which can lead to severe kidney damage, kidney failure and sometimes death.
"Patients and healthcare providers should consider all potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy," said Dr. Eric Colman, deputy director of FDA’s Division of Metabolism and Endocrinology Products.
The agency also requested that Merck, which makes Zocor, change labeling to warn doctors against prescribing greater than 40 mg. to patients taking diltiazem for high blood pressure.