High-Dose Simvastatin Linked to Increased Myopathy and Death
The FDA said it has also instructed Merck, which markets simvastatin, to “change the product labeling to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.”
This is not the first time that the FDA has warned about high-dose simvastatin, but it said today that its review of prescription data revealed that “despite dose limitations and drug-drug interaction precautions included in the simvastatin drug label, patients are continuing to be prescribed higher doses of simvastatin with other medications that are known to increase the risk for rhabdomyolysis.”
Myopathy is a recognized side-effect of all statin therapy, regardless of agent. Symptoms include muscle pain, tenderness or weakness, and increased serum creatine kinase.
The FDA also warned that more than 10 mg of simvastatin should not be used with gemfibrozil, cyclosporine, or danazol, and more than 20 mg should not be used with amiodarone or verapamil.
For all patients, do not take simvastatin when using these drugs:
–HIV protease inhibitors
Patients should not take more than 10 mg. of Zocor daily with these drugs:
They should not take more than 20 mg. with these drugs:
And they should not use more than 40 mg. with this drug:
Simvastatin is also sold in a generic form, as well as in a combination with ezetemibe known as Vytorin and in a combination with niacin known as Simcor.
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