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Multaq  Linked to Life-Threatening Injuries Including Liver Failure, Heart Attack, and Stroke

Multaq (dronedarone) is a prescription 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. Since its FDA approval in 2009, approximately 1 million Multaq prescriptions have been dispensed in the United States. In 2011, the FDA issued two safety warnings which linked Multaq to life-threatening injuries including liver failure, heart attack, and stroke.

SEVERE LIVER INJURIES

In January 2011, the FDA issued a warning notifying healthcare professionals about severe liver injuries associated with use of the heart drug Multaq. The warning cited several cases of liver failure, including two cases in which patients needed liver transplants. Symptoms of liver failure include:

  • Anorexia
  • Nausea
  • Vomiting
  • Itching
  • Fever
  • Malaise
  • Fatigue
  • Jaundice
  • Dark urine
  • Light colored stools
HEART FAILURE, STROKE, AND DEATH

In July 2011, the FDA issued another Multaq warning, this time notifying patients and healthcare providers that results from a clinical trial revealed that the drug doubled the risk of heart failure, stroke, and death in patients with permanent atrial fibrillation.

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