(2005; 12 pages)
AMIODARONE - Medication Guide to be dispensed along with medicine
USA. Wyeth Pharmaceuticals Inc., under advice from the United States Food and Drug Administration (US FDA), is directing health professionals to distribute a medication guide to all patients while dispensing amiodarone (Cordarone) tablets to those patients. Amiodarone, an antiarrhythmic drug, is associated with substantial toxicity and is, therefore, indicated only in patients with life-threatening arrhythmias.
The medication guide highlights some of the serious and potentially fatal side-effects that may result from the use of amiodarone and provides general information to the patient about amiodarone, conditions when amiodarone may not be taken, relevant medical history that a patient needs to share with the physician before starting the medication, etc. However, this guide is not to be used as a substitute for talking to patients about the risks relative to benefits associated with taking amiodarone tablets.
'Dear Health-care Professional' letter from Wyeth Pharmaceuticals Inc., 30 December 2004. Available on the Internet at www.fda.gov