Story of Dronedarone (Multaq) Another instance of version 2.0 Sucks

CONCLUSION — Dronedarone (Multaq) is less effective than amiodarone for treatment of patients with non-permanent atrial fibrillation, is apparently dangerous in those with permanent atrial fibrillation, and generally has an incidence of serious adverse effects that seems to be higher than previous reports suggested.

Safety of Dronedarone (Multaq)Sanifi Aventis


Cordarone Pfizer 

Another instance of version 2.0 Sucks

Med Lett Drugs Ther. 2011 Dec 12;53(1379):103-4
Dronedarone (Multaq – Sanofi), an analog of amiodarone, was approved by the FDA in 2009 for oral treatment of paroxysmal or persistent (non-permanent) atrial fibrillation or atrial flutter.1 Amiodarone (Cordarone, and others) is more effective for this indication,2 but its use is often limited by its adverse effects, including thyroid and pulmonary toxicity.

ADVERSE EFFECTS OF DRONEDARONE — Diarrhea, nausea, vomiting, abdominal pain and rash can occur with dronedarone, but unlike amiodarone, significant thyroid or ocular toxicity has not been reported to date. Photosensitivity has been reported, but not the blue-gray skin discoloration associated with amiodarone. Both amiodarone and dronedarone have the potential to interact with many other drugs taken concomitantly.

After an earlier trial was terminated prematurely because of a significant increase in mortality in dronedarone-treated patients, the drug was contraindicated for use in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with recent decompensation. Dronedarone suppresses sinus node activity and atrioventricular (AV) conduction and is therefore also contraindicated in patients with second- or third-degree AV block or sick sinus syndrome (unless used in conjunction with a pacemaker), and in those with bradycardia (<50 beats="" minute="" p="">
NEW WARNINGS — In January 2011, the FDA warned that use of dronedarone had been associated with severe liver injury and hepatic failure, including two cases that required liver transplantation.3

Six months later, the FDA notified healthcare professionals that a large clinical trial, which has recently been published, in patients with permanent (>6 months) atrial fibrillation (not an FDA-approved use of the drug) was terminated prematurely because, compared to placebo, the risks of stroke (23 vs. 10), hospitalization for heart failure (43 vs. 24) and death from cardiovascular causes (21 vs. 10) were higher in those treated with dronedarone.4,5

CONCLUSION — Dronedarone (Multaq) is less effective than amiodarone for treatment of patients with non-permanent atrial fibrillation, is apparently dangerous in those with permanent atrial fibrillation, and generally has an incidence of serious adverse effects that seems to be higher than previous reports suggested