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.
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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.