FDA Warns Risk of Muscle Injury Linked to Simvastatin

Thursday, February 05, 2009 by: David Gutierrez, staff writer
Tags: side effects, health news, Natural News

(NaturalNews) The FDA has issued a warning that the popular cholesterol-lowering drug simvastatin, when mixed with the anti-arrhythmia drug amiodarone, can cause a rare muscle injury that can lead to kidney failure or even death.

Simvastatin is also marketed as Zocor, Denan, Lipex, Liponorm, Lipovas, Lodales, Simcard, Simlup, Simovil, Simvacor, Simvahexal, Simvaxon, Simvotin, Sinvacor, Sivastin, Zimstat and Zocord. It is also an ingredient in the drug Vytorin. Amiodarone is also marketed as Pacerone, and is an ingredient in Cordarone.

All of the cholesterol-lowering statin drugs are known to increase a patient's risk of the muscle-damaging condition known as rhabdomyolysis when mixed with amiodarone, but the risk is greatest for simvastatin, the FDA said. Simvastatin doses higher than 20 mg per day particularly increase the risk.

Amiodarone blocks the action of the same enzyme that metabolizes simvastatin in the body.

Since issuing its first warning about mixing the drugs in 2002, the agency has received 52 more reports of rhabdomyolysis related to the practice. Only six cases were reported in relation to mixing amiodarone with other statins.

"Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone," the FDA said.

The FDA advised doctors to consider prescribing a different statin for patients who need to take amiodarone to control a potentially fatal abnormal heart beat condition. It said that any patients who are mixing amiodarone and statins should contact the doctor at once if they notice any unexplained muscle stiffness, tenderness, pain, cramps or spasms.

Rhabdomyolysis refers to a rapid disintegration of skeletal muscle tissue that floods the bloodstream with muscle metabolites. These metabolites can damage the kidneys and cause them to fail, as well as causing nausea, vomiting, confusion, electrolyte imbalance, abnormal heart beat and even death.

Sources for this story include: uk.reuters.com; www.medpagetoday.com.