Multaq Recommended As a Second- or Third-Line Treatment

Los Angeles, CACiting concerns about the risk of Multaq side effects, scientists have warned that Multaq not be used as a first-line treatment for certain conditions. Although Multaq warnings have been issued by the US Food and Drug Administration (FDA) and international health agencies, the atrial fibrillation drug is still available on the market. In December 2011, however, the FDA announced that clinical trials suggested an increased risk of Multaq health problems.

One study, published in April 2010 in the Journal of the American College of Cardiology, suggests that Multaq is not nearly as effective as a generic drug and should only be used if other medications do not work. The study, conducted by researchers from the Cedars-Sinai Medical Center, found that Multaq is only half as effective as amiodarone, which is also used to control atrial fibrillation. Because Multaq (known generically as dronedarone) has been linked to serious side effects and because it is much more expensive than generic medications, researchers recommend that other drug therapy be tried before a patient is put on Multaq.

According to the Cedars-Sinai review, two previous studies examined the safety of Multaq. The first, the ANDROMEDA (Antiarrhythmic Trial With Dronedarone in Moderate-to-Severe Congestive Heart Failure Evaluating Morbidity Decrease) trial, was ended early because of "excess mortality" among patients who received dronedarone. "The excess mortality appeared to be predominantly related to worsening heart failure, followed by arrhythmia and sudden death," researchers noted.

Meanwhile, the ATHENA (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter) trial showed a significantly decreased risk of death in patients who used Multaq. It was largely because of the ATHENA study that the FDA approved dronedarone to reduce the risk of hospitalization for cardiovascular problems in patients with atrial fibrillation. But Cedars-Sinai researchers noted that there were some problems with the ATHENA trial, including the quality of data regarding death linked to cardiovascular problems.

Those issues led researchers to conclude that because dronedarone is only moderately effective and carries serious concerns about short- and long-term safety, it should only be used as a second- or third-line treatment.

A different Multaq study, called PALLAS (Permanent Atrial fibrillation outcome Study using Dronedarone on top of standard therapy), was also halted early because of concerns about an increased risk of serious heart-related events in patients who were given the medication.