According to a report from the Los Angeles Times (4/5/10), Multaq, known generically as dronedarone, was shown in at least one study to be less beneficial than a generic drug. The study, published in the Journal of the American College of Cardiology in April 2010, found that dronedarone was only half as effective as generic drug amiodarone and did not have fewer side effects than the generic drug.
In other words, patients taking Multaq had the same risk of side effects but fewer benefits than they would have had if they had taken a generic drug, according to the study.
Researchers involved in the study, from Cedars-Sinai Medical Center, said Multaq should only be used if all other drugs fail, rather than as a first-choice drug. Multaq is used to reduce hospitalizations due to atrial fibrillation, which occurs when heart has abnormal beats or flutters because of unusual electrical signals in the atrium. When this happens, blood can pool in the heart, causing a potentially fatal stroke.
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In December 2011, the FDA issued a Drug Safety Communication (12/19/11), warning that a safety review of Multaq showed an increased risk of serious cardiovascular events, including death, when patients with permanent atrial fibrillation used the drug. The safety review included data from two trials. One of the trials, PALLAS (Permanent Atrial FibriLLAtion Oucome Study Using Dronedarone on Top of Standard Therapy), was terminated early because of the high number of cardiovascular events in patients given Multaq when compared with patients given a placebo.
Multaq was approved by the FDA in 2009. It is approved for patients with non-permanent atrial fibrillation (also called paroxysmal or persistent atrial fibrillation).