Weighing the Pros and Cons of Multaq

Houston, TXWhen it comes to determining whether the risks of Multaq side effects are worth the benefits, patients might consider the Multaq warning issued by the US Food and Drug Administration. They might also take into account the risk of Multaq liver damage and Multaq contraindications. But because the drug is used to treat a heart condition, they might think that all those risks are outweighed by the benefits.

Multaq, known generically as dronedarone, is used to treat patients with atrial fibrillation during the past six months, to prevent recurrence of the condition. Studies have shown that the drug reduces the number of heart-related hospital visits, which was encouraging for medical professionals. But new studies, including one that was stopped early because of adverse reactions, suggest that while the drug is beneficial for some patients, it may be harmful to others.

On January 14, 2011, the FDA issued a warning about rare but severe liver injury associated with Multaq, "including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone." At the time, FDA noted that dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) to prevent it from being used in patients with severe heart failure. Furthermore, according to FDA, patients with severe heart failure and patients who were recently in the hospital for heart failure had more than two times increased risk of death when given dronedarone.

Patients are urged to watch for signs of liver problems, including itching, yellow eyes or skin, dark urine or loss of appetite.

Later the same year, FDA issued another warning about the drug, elaborating on the risk of serious cardiovascular events linked to the use of Multaq. In July 2011, the FDA warned that a study (PALLAS, Permanent Atrial fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) was halted early because of a two-fold increased risk of death and serious cardiovascular adverse events when given to patients with permanent atrial fibrillation (which is not an approved use of the drug).

The FDA ultimately recommended that Multaq not be used in patients with permanent atrial fibrillation.