FDA warns of increased myopathy risk with high dose Zocor

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The FDA has notified healthcare professionals that there could be an increased risk of myopathy associated with the highest approved dose of Zocor (simvastatin, from Merck) 80mg, compared to lower simvastatin doses and possibly other drugs in the “statin” class. The FDA is reviewing data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.