The FDA is warning about the risk of rhabdomyolysis when the cholesterol-lowering drug simvastatin is combined with amiodarone, an anti-arrhythmic drug sold as Cordarone or Pacerone.
What is Simvastatin?
Simvastatin is a cholesterol-lowering drug in the statin class. It is prescribed to reduce LDL cholesterol levels, which reduces the risk of heart attack and stroke. Simvastatin is sold under the following brand-names:
What is Amiodarone?
Amiodarone is a heart drug that is prescribed to treat irregular heart rhythm. It is approved to treat ventricular tachycardia and ventricular fibrillation. Amiodarone is sold under the following brand-names:
Severe Side Effects of Amiodarone
In 2005, the FDA issued a Safety Warning to warn about severe lung damage (pulmonary toxicity), liver damage, and worsening heart problems from Amiodarone. Patients can also suffer from vision problems, blindness, muscle damage, kidney problems, and even death.
FDA Warning: Amiodarone + Simvastatin
The FDA has published several safety communications about the increased risk of muscle injury (myopathy) and rhabdomyolysis when amiodarone and simvastatin are combined.
- August 8, 2008 — Safety Communication — Since updating the label on simvastatin in 2002 to warn about rhabdomyolysis, the FDA continues to receive dozens of adverse events from people who were prescribed the drug combination.
- December 15, 2012 — Safety Communication — The FDA recommends that patients who are using amiodarone and simvastatin should limit the dose of simvastatin to 20-mg due to the risk of muscle disease.
Simvastatin + Amiodarone Side Effects
The label on simvastatin was originally revised in 2002 to warn about the risk of rhabdomyolysis when it is combined with amiodarone, especially in doses greater than 20-mg per day. Despite these warnings, the FDA has continued to receive reports of people who were injured by this drug combination.
What is Rhabdomyolysis?
Rhabdomyolysis is a life-threatening muscle disease. It occurs when muscle fibers break down, release a protein called myoglobin into the bloodstream, which clogs the filtering tissues in the kidneys. Severe cases can cause kidney damage, kidney failure, and even death.