Using the cholesterol-lowering drug simvastatin with the anti-arrhythmic drug amiodarone may increase a patient’s risk of rhabdomyolysis, a life-threatening degenerative muscle disease.
What is Simvastatin?
Simvastatin is a statin that reduces the amount of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”) in the body. This reduces the risk of stroke, heart attack, and cardiovascular death. It is sold under the following brand-names:
- Zocor (single-ingredient simvastatin)
- Vytorin (simvastatin + ezetimibe)
- Simcor (simvastatin + niacin), extended-release
What is Amiodarone?
Amiodarone is a heart drug for patients with irregular heart rhythm. It specifically treats ventricular tachycardia in the two lower chambers on the heart. Amiodarone is sold under the following brand-names:
What is the problem?
In 2005, the FDA issued a Safety Communication to warn about severe, life-threatening side effects of amiodarone, including lung damage (pulmonary toxicity), liver damage, and worsening irregular heart rhythm. Patients on amiodarone can also suffer vision loss, blindness, loss of muscle coordination, and even death.
FDA Warning: Simvastatin + Amiodarone
- August 8, 2008: FDA Safety Communication to warn that they continue to receive reports of rhabdomyolysis among patients taking amiodarone and simvastatin, especially among people taking more than 20-mg of simvastatin per day.
- December 15, 2012: FDA Safety Communication to recommend that patients who take both simvastatin and amiodarone should not exceed 20-mg per day due to the increased risk of muscle injury (myopathy) and rhabdomyolysis.
FDA Continues to Receive Reports of Rhabdomyolysis
In May 2002, the FDA warned about the risk of rhabdomyolysis when amiodarone is taken with simvastatin in doses greater than 20-mg per day. Unfortunately, despite the warnings, the FDA continued to receive reports of rhabdomyolysis in patients treated with amiodarone and simvastatin, particularly among patients taking more than 20-mg of simvastatin per day.
What is Rhabdomyolysis?
Rhabdomyolysis is a severe, life-threatening type of degenerative muscle disease. It occurs when muscle fibers break down and release a protein called myoglobin. Myoglobin is filtered out of the bloodstream by the kidneys, which can become clogged, causing kidney damage. Severe cases can cause kidney failure and death.
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