January 13, 2005

Pharmacists and prescribers are now required to give patients a Medication Guide for amiodarone tablets (Cordarone®, generic) whenever the drug is dispensed, due to the risk of severe toxicity. The most common fatal toxicity of amiodarone is hypersensitivity pneumonitis or interstitial/alveolar pneumonitis (10-17%). Liver disease has been fatal in a few cases. Potential worsening of arrhythmias, heart block, or sinus bradycardia are also toxicities (2-5%). All manufacturers of amiodarone (generic and brand) are required to provide Medication Guides with the product. Additional information is available online at the FDA MedWatch website at the following links:

• http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Cordarone (general MedWatch warning)
• http://www.fda.gov/medwatch/SAFETY/2005/cordarone_DHCP.htm (letter to health care providers)
• http://www.fda.gov/medwatch/SAFETY/2005/cordarone_dear_pharm.htm (letter to pharmacists)
• http://www.fda.gov/medwatch/SAFETY/2005/Cordarone_Med_Guide.pdf (medication guide for patients)
• http://www.fda.gov/medwatch/SAFETY/2005/Cordarone_PI_01-06-05.pdf (revised product labeling)

Distribution of Medication Guides may be required with other medications that the FDA determines pose a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician's discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.