Is Multaq Worth the Risks?

Boston, MAWhen patients deal with serious drug side effects, such as Multaq side effects, they often assume that, despite the side effects, they are taking the best medication available, making the side effects a necessary evil. But for people suffering from Multaq problems, especially in the face of recent Multaq warnings, news that Multaq may not have been the best drug is probably surprising.

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.

Dronedarone was made by Sanofi-Aventis and was thought to have fewer side effects, although a clinical trial of the drug reportedly showed that it doubled the rate of death. The FDA then approved the drug, but only to reduce hospitalizations associated with atrial fibrillation.

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).