WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoAMIODARONE - Medication Guide to be dispensed along with medicine
Ver el documentoATOMOXETINE - Labelling to include liver injury warning
Ver el documentoBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
Ver el documentoMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
Ver el documentoPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
Ver el documentoSMALLPOX VACCINE - Label to highlight reports of myopericarditis
Ver el documentoTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoDRUGS OF CURRENT INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

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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