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FDA Alerts

(UPDATE 12/15) 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.

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