Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

More bad news for the cholesterol-lowering drug Vytorin. The drug has been under scrutiny lately for everything from elevated cancer risk and serious side effects to ineffectiveness. This week, the Food and Drug Administration (FDA) issued a safety announcement about simvastatin, one of the two active ingredients found in the medication, and an increased risk of a potentially life-threatening muscle injury.

Vytorin combines simvastatin (sold as in individual ingredient under the brand name Zocor) and ezetimibe (also known as Zetia) to reduce the production of “bad” cholesterol. An FDA review of data from clinical studies, adverse event reports, and prescription use of simvastatin indicated patients who took doses of 80 mg or more of simvastatin were at greater risk for developing a muscle injury known as myopathy. Myopathy, which causes pain, tenderness or weakness, is a known side effect of all statin drugs. Myopathy can lead to rhabdomyolysis, a more serious condition that can lead to kidney failure, which can be fatal.

Much of the data reviewed by the FDA came from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), a clinical trial aimed to better understand the relationship between high-dose simvastatin use and muscle injury.

Vytorin also carries a risk of liver damage and liver problems such as hepatitis, cirrhosis and even liver failure. A February 2008 study also found that Vytorin was no more effective than simvastatin alone in lowering cholesterol, and that patients taking Vytorin actually had more plaque buildup than patients taking simvastatin alone.

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