Pharmaceutical Drug Injury

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The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication Multaq (dronedarone).

Multaq (dronedarone) is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Multaq can reduce the risk of being hospitalized for these heart problems. Since the drug's approval in July 2009 through October 2010, around 492,000 Multaq prescriptions were dispensed and around 147,000 patients filled Multaq prescriptions at outpatient retail pharmacies in the United States. Additional usage can occur in the hospital setting.

Multaq was approved with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given Multaq had a greater than two-fold increase in risk of death.

Additional Information for Patients

• Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
• Talk to your healthcare professional about any concerns you have with this medication.
• Do not stop taking dronedarone unless told to do so by your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program.
• Read the Medication Guide when picking up a prescription for Multaq. It will help you understand the potential risks and benefits of this medication.