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Simvastatin associated with increased risk for muscle injury
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The FDA warned patients and health care providers today about the potential for rhabdomyolysis, a serious form of myopathy, in patients prescribed higher doses of simvastatin.
Although myopathy is a known adverse event with statins, the risk may be greater with simvastatin, according to an FDA press release. Rhabdomyolysis can lead to severe kidney damage, kidney failure and death.
Simvastatin (Zocor, Merck) is sold in single-ingredient formulations and in combination with ezetimibe (Vytorin, Merck/Schering Plough) and niacin (Simcor, Abbott). The warning is based on an agency review of simvastatin in clinical trials, observational studies, adverse event reports and prescription use data. The FDA is currently reviewing additional data from the SEARCH trial, which evaluated major CV events such as MI, revascularization and CV death among patients taking simvastatin 80 mg vs. 20 mg.
“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,” Eric Colman, MD, deputy director of the FDA’s division of metabolism and endocrinology products, said in the release. “It’s important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”
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