Friday, September 23, 2011


I have just read the announcement by the European Medicine Agency ( EMA ), that they will be recommending restricting the use of dronedarone. This is of course, following the release of the PALLAS data, which showed that the use of Dronedarone in patients with permanent atrial fibrillation was associated with a higher incidence of cardiovascular events. There were several small studies which seem to suggest that Dronedarone may also be associated with liver and lung damage ( sounds like amiodarone !! ).
Dronedarone is an anti-arrhythmic manufactured by Sanofi Adventis, for the use in patients with paroxysmal atrial fibrillation or persistent, but non-permanent atrial fibrillation, to try and chemo-revert them and also to maintain sinus rhythm. It was launch by Sanofi Adventis in the early part of this year in Malaysia, with some pomp and fanfare, all staff dressed up in Greek attire to reflect the ATHENA study, which promote the use of Dronedarone.
I do have a few patients on Dronedarone. In two of them, with paroxsymal atrial fibrillation, it failed to convert and failed to maintain. One of them had severe gastric upset and refused to take the drug. There is only one patient left on dronedarone. I must inform him, when he next comes for checkup, that there are problems with this drug.
The US FDA never approved its use, so this is not an issue in USA.

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