FDA announces new safety recommendations for high-dose simvastatin (USA)

The U.S. Food and Drug Administration is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose - 80 milligram (mg) - has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use. The agency is recommending that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications