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FDA Approves Labeling Changes for All Statins

May 18, 2012
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These clarifications include but are not limited to: Use may be associated with hyperglycemia and elevated A1c; Use may be associated with the potential for cognitive adverse effects; Periodic monitoring of liver function tests is no longer required. Lovastatin labeling was revised to include contraindications and dose limitations for certain drug interactions which can increase drug exposure and subsequent risk for rhabdomyolysis. Lovastatin is contraindicated with strong cytochrome (CYP) 3A4 inhibitors, such as clarithromycin and ketoconazole. Daily doses should not exceed 20 mg with diltiazem, verapamil, and danazol. Daily doses should not exceed 40 mg with amiodarone. Medscape News