Safety Alerts & Recalls

What does this mean?

Although this FDA alert is about simvastatin and amiodarone, other statins such as atorvastatin (Lipitor) or lovastatin (Mevacor) are likely to be affected in the same way as simvastatin when used with amiodarone.

If you are taking either simvastatin, lovastatin or atorvastatin, speak to you doctor about your risk of muscle injury and what you can do to minimize your risks - especially if you are also taking amiodarone. Some of the other statins such as fluvastatin (Lescol), pravastatin (Pravachol), and rosuvastatin (Crestor) may be safer alternatives in patients receiving amiodarone, since they are metabolized differently.

Keep in mind that muscle damage, although rare, is a risk of using any statin - even if you are not taking amiodarone. Thus, if you are taking a statin, promptly report to your doctor if you experience any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever.

Combination use can lead to rare condition of muscle damage

The FDA is notifying the public of an increased risk of muscle breakdown (rhabdomyolysis) when the cholesterol-lowering medication simvastatin (marketed as Zocor and generics), Ezetimibe/Simvastatin (marketed as Vytorin), or Niacin Extended-Release /Simvastatin (marketed as Simcor), is used with amiodarone (Cordarone, Pacerone), a drug used for abnormal heart rhythms. Rhabdomyolysis is a rare condition which can lead to kidney failure if not detected early. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone.

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Source: FDA
Publication Date: 2008-08-08
Last Updated: 2009-12-06

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