FDA Announces New Safety Recommendations For High-Dose Simvastatin
The U.S. Food and Drug Administration today 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 ...