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FDA Announces New Safety Information for High-Dose Simvastatin

Yesterday the U.S. Food and Drug Administration announced label changes for the cholesterol-lowering medication simvastatin.  THe FDA warned that the highest approved dose--80 mg--has been associated with an elevated risk of muscle injury or myopathy, particularly during the first twelve months of use. 

The Drug Information Update released by the FDA recommends 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.  The FDA stated that this dosage should not be prescribed for new patients.  The warning also included new contraindications and dose limitations for when simvastatin is taken with certain other medications. 

The FDA was prompted to alert patients and healthcare providers based on its review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial and other data.  The results showed an increased risk of muscle injury when using the 80 mg dose compared with other lower dosage options.   

Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product.  It is also sold in combination with ezetimibe as Vytorin and in combination with Niacin as Simcor. 

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