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FDA still receiving many adverse incidents about the concurrent administration of the two products.
Although a revision in simvastatin's labeling in 2002 warned that patients taking both the cholesterol-lowering drug and amiodarone are at increased risk of coming down with rhabdomyolysis, the Food and Drug Administration reports that it is still receiving all too many adverse incidents about the concurrent administration of these two products. The agency warned that the risk of rhabdomyolysis increases when simvastatin is given at doses greater than 20 mg a day along with amiodarone. Prescribers should avoid ordering doses of simvastatin greater than 20 mg per day for patients taking amiodarone as rhabdomyolysis can lead to kidney failure or death.