Pharmacy Services
Simvastatin products (Zocor, Zetia, Simcor, generic) and Amiodarone (Cordarone, Pacerone, generic) - Potentially Serious Interaction
August 11, 2008
The FDA is reminding health care professionals that serious interactions may occur when amiodarone is given with simvastatin doses greater than 20 mg/day. This combination may increase the risk of dose-related myopathy, including potentially fatal rhabdomyolysis. The product labeling for both agents was revised in 2002 to include this interaction. The simvastatin product labeling was also revised to recommend a maximum dose of simvastatin 20 mg/day when given with amiodarone. However, the FDA has continued to receive reports of rhabdomyolysis in patients receiving higher doses of simvastatin (> 20 mg/day) with amiodarone.
This interaction may occur with single agent simvastatin (Zocor, generic), as well as with simvastatin combination products, including ezetimibe/simvastatin (Zetia) and extended-release niacin/simvastatin (Simcor). No additional changes are currently being made to the interaction section of either product labeling. More information is available at the following links:
- MedWatch Warning:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm095009.htm - Drug Information Page:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118869.htm - Information for Healthcare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124362.htm - Product labeling for simvastatin (single agent and combination products):
http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=simvastatin - Product labeling for amiodarone:
http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=amiodarone&x=10&y=11
Updated
August 11, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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