WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentAMIODARONE - Medication Guide to be dispensed along with medicine
View the documentATOMOXETINE - Labelling to include liver injury warning
View the documentBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
View the documentMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
View the documentPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
View the documentSMALLPOX VACCINE - Label to highlight reports of myopericarditis
View the documentTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF CURRENT INTEREST
Open this folder and view contentsFEATURE
 

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.

Reference:

'Dear Health-care Professional' letter from Wyeth Pharmaceuticals Inc., 30 December 2004. Available on the Internet at www.fda.gov

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