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FDA reiterates warning of muscle injury risk when heart drugs combined
Tuesday, August 19 2008 | Comments
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The Food and Drug Administration warned the public of the risk of the rare condition of muscle injury, rhabdomyolysis, when the cholesterol-lowering agent simvastatin is used with the arrhythmia drug amiodarone.The agency said the risk is dose-related and increases when a dose of simvastatin >20 mg/day is given with amiodarone.
Although simvastatin's labeling was revised in 2002 to describe an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses >20 mg/d, the FDA said it continues to receive reports of the muscle injury in patients treated concurrently with the two drugs, particularly with simvastatin doses >20 mg/d.
The agency said prescribers should know about the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin >20 mg/d in patients receiving amiodarone.
Prescribers should also advise patients starting therapy with simvastatin or whose dose of simvastatin is being increased of the risk of rhabdomyolysis and to report promptly any unexplained muscle pain, tenderness, or weakness.
The agency also said that another statin should be considered for patients who are already taking or initiating amiodarone therapy and who require simvastatin doses >20 mg daily to meet their lipid goals. Even though the FDA noted that rhabdomyolysis has been reported with all statins, the risk of the disease is higher with simvastatin as compared with other statins when administered with amiodarone.
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