MB: FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. The drug is sold as Zocor, and it's also an ingredient in Vytorin (ezetimibe/simvastatin) and Simcor (niacin extended-release/simvastatin).
AR: Myopathy is a known side-effect of all statin drugs, as is rhabdomyolysis, a potentially life-threatening type of myopathy. The higher the statin dose, the greater the risk of developing myopathy or rhabdomyolysis. The clinical trial showed that the risk of myopathy is much higher in patients taking 80 mg of simvastatin, which is the highest approved dose, than in those taking 20 mg.
MB: The risk of myopathy is also increased when simvastatin is used with certain other medications. In fact, simvastatin should be avoided in people taking certain drugs, and there are specific dose limits when it's prescribed with other drugs. You'll find a complete list on our website.
AR: When deciding to use simvistatin, practitioners should consider the drug's potential risks and known benefits, compared to other cholesterol-lowering therapies. And before prescribing simvastatin, they should carefully review the patient's medications for potential drug-drug interactions.

标题
Muscle Injury from High Zocor Doses (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
FDA is informing healthcare professionals that a large clinical trial may show an increased risk of muscle injury caused by high doses of the statin drug simvastatin, sold as Zocor.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration