
In a drug safety communication, the FDA reported that a review of data shows that patients taking
the highest approved dose of simvastatin, sold generically and by Merck & Co. as Zocor, and in combination with ezetimibe as Vytorin, as well as in Abbott's Simcor with niacin, had an increased risk of myopathy compared to those taking lower doses of the drug or other statins.
Data from the SEARCH trial demonstrate that 52 of 6031 patients taking the 80-milligram dose of simvastatin experienced myopathy, compared to 1 of 6033 patients taking a 20-milligram dose of the drug. In addition, 11 patients in the higher dosing group developed rhabdomyolysis compared to no patients in the lower-dose arm.
While the agency noted that myopathy is a known side effect with all statin medications, it said that "it is important for healthcare professionals to consider the potential risks and known benefits of simvastatin compared to other cholesterol-lowering therapies when deciding to use simvastatin."
In response to the news, Merck stated that "labeling for simvastatin-containing products reflects the potential risk of skeletal muscle effects from simvastatin, including an increased risk at higher doses."