FDA Alert: Risk of rhabdomyolysis when simvastatin is used with amiodarone

The FDA issued the following MedWatch Alert today regarding simvastatin used in combination with amiodarone.  The alert reads as follows:

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


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Heart Device Makers Plan Enhanced Safety Reviews

In an attempt to improve patient safety, national heart device manufacturers have committed to better research and evaluation of their products before they hit the market.

This safety plan comes after the release of several defective heart products, ranging from difibulators to deadly St. Jude Silzone heart valves.

The decision was influenced by a Heart Rhythm Society report, which called on device makers to create, among other things, independent panels of doctors and other specialists to review product safety.

In response to the Heart Rhythm Society’s request, Medtronic Inc. and St. Jude both announced plans to involve a greater number of outside doctors in the product research and development phase.

The full article as reported in the New York Times can be found here.

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