FDA Review of Multaq Side Effects

Washington, DCThe US Food and Drug Administration (FDA) announced in July 2011 that it was reviewing possible Multaq side effects after data from a study indicated an increased risk of Multaq heart problems. The FDA's announcement came following information that a Multaq atrial fibrillation study was stopped early due to serious dronedarone side effects.

Multaq, known generically as dronedarone, is used to reduce the risk of hospitalization in patients who have paroxysmal or persistent atrial fibrillation (known as AF or AFib) or atrial flutter. A study undertaken by Sanofi Aventis (maker of Multaq), called the Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, was designed to test the benefit of Multaq in patients older than 65 years with permanent atrial fibrillation. That study was ended prematurely, however, after data indicated two times the increased risk of death and two times the increased risk of stroke and hospitalization for heart failure in patients who received Multaq when compared with patients who were given a placebo.

Because the indication for the Multaq PALLAS trial was unapproved—the trial studied patients with permanent atrial fibrillation, while Multaq is approved for patients with non-permanent atrial fibrillation—it is not known if the increased risk of death, stroke or hospitalization extends to patients who take Multaq for non-permanent atrial fibrillation.

In making its announcement (07/21/11), the FDA warned, "Patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation." The agency warned that patients should not discontinue medication without speaking to a health care professional.

The news about the PALLAS study was the second Multaq announcement issued by the FDA in 2011. The first concerned the potential risk of rare but serious liver injury and was issued on January 14, 2011. In that case, the FDA warned health care professionals and patients about the potential risk of severe liver injury, including two cases of acute liver failure that resulted in liver transplants in patients who used Multaq.

In addition to noting that the warning label was being updated to include a potential risk of liver injury, the FDA noted that patients with severe heart failure could also be at an increased risk of death.

"Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure," the FDA stated in its safety announcement (07/14/11). "In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death."

Patients who take Multaq and have signs of liver injury, such as itching, yellow eyes or skin, or dark urine or loss of appetite are encouraged to speak to their health care professional.