March 19, 2010, 02:00:00PM. By Heidi Turner

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Silver Spring, MD: The US Food and Drug Administration (FDA) issued a warning about the potential for an increased risk of muscle injury when patients use 80 mg of Zocor (simvastatin). The muscle injury, known as myopathy, is a side effect of all statins; however, the warning highlights the increased risk of developing this injury when patients use higher doses of Zocor. The warning includes an increased risk of rhabdomyolysis, a serious form of myopathy that can lead to kidney damage, kidney failure and death.

"Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available," said Eric Colman, M.D., Deputy Director of FDA's Division of Metabolism and Endocrinology Products (DMEP). "It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy."

Simvastatin is sold as the brand name Zocor and is also sold in combination medications. When sold in combination with ezetimibe, the medication is called Vytorin. When sold in combination with niacin, the medication is called Simcor.

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