On March 19, 2010, the U.S. Food and Drug Administration (FDA) issued an alert indicating that using simvastatin (marketed as Zocor^®) at the highest approved dose is associated with an increased risk for myopathy, a muscular disease that results in muscle weakness. Simvastatin is a commonly –prescribed medication used for lowering cholesterol.

This alert regarding simvastatin was based on a review of data from a large clinical trial called  Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). The SEARCH trial evaluated the number of major cardiovascular events in 6031 patients with a history of heart attack who were taking 80 mg of simvastatin, the highest approved dose of the cholesterol-lowering drug., compared to the number of events in 6033 patients taking 20 mg of simvastatin. According to preliminary results, patients taking 80 mg of simvastatin were more likely to develop myopathy. In addition, 11 patients in the simvastatin 80-mg group developed rhabdomyolysis, the most serious form of muscle disease leading to the rapid breakdown of skeletal muscle. No patients in the simvastatin 20-mg group developed this serious muscle injury.

The FDA is currently reviewing data from other sources, including clinical trials, observational studies, adverse event reports, and data on the prescription use of simvastatin. Healthcare professionals are advised to consider the increased risk for muscle injury with the 80-mg dose of simvastatin when discussing the potential benefits and risks of simvastatin.  

For more information on the FDA alert regarding simvastatin, click here. 

Source:

U.S. Food and Drug Adminstration. FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Available at www.fda.gov. Accessed 20 March 2010.