FDA Announces Prescribing Information
The US Food and Drug Administration recently announced changes to the safety label for the 80 milligram (mg) dose of simvastatin in the use of cholesterol lowering. The changes are the result of the FDA's review of recent clinical trials including the seven-year Study for the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and adverse events reported to the agency. All patients on the 80 mg simvastatin therapy showed a greater risk of myopathy compared to patients taking lower doses or even other statins.
This page was last updated: Oct 13, 2013


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