FDA Issues New Recommendation for High-Dose Simvastatin

June 16, 2011 11:06 am

FDA is alerting health care providers and patients, that the highest approved dose (80 mg) of the cholesterol-lowering medication simvastatin, has been associated with an elevated risk of muscle injury or myopathy. This warning applies to patients particularly during the first 12 months of use. FDA advises 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. It should not be prescribed to new patients, advises FDA. The agency notes that there are also new contraindications and dose limitations for when simvastatin is taken with certain other medications. FDA is making label changes for simvastatin-containing medications based on the agency’s “review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs.” Additional details are available in an FDA Drug Safety Communication.