FDA MedWatch

FDA MedWatch - Simvastatin Used With Amiodarone - Risk of rhabdomyolysis when simvastatin is used with amiodarone

08/09/2008- FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. 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.

Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin