Muscle Injury with Simvastatin/Amiodarone Combination

FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antiarrhythmic drug and simvastatin (found in Zocor, Vytorin and Simcor) is used to lower cholesterol.

This increased risk has been described in the labeling for both amiodarone and simvastatin since 2002, but FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with these two drugs, especially when the simvastatin dose is greater than 20 mg per day. Prescribers should avoid doses of simvastatin greater than 20 mg per day in patients who are also taking amiodarone.

When patients start taking simvastatin or their dose is increased, they should be told about the risk of rhabdomyolysis and advised to promptly report any unexplained muscle pain, tenderness or weakness.

Additional Information:

FDA MedWatch Safety Alert. Simvastatin Used With Amiodarone. August 8, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin