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Liver Failure Reported in Multaq Patients | 24-7-news.com cialis online

Liver Failure Reported in Multaq Patients

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Two patients talking Multaq (dronedarone) have developed liver failure so severe they required a liver transplant. According to a Food & Drug Administration (FDA) issued late yesterday, there have also been “several” instances of liver injury reported in Multaq (dronedarone) patients.

Multaq (dronedarone) is use to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. It was only approved in by the FDA in 2009.

In a letter to health care professionals, Sanofi-Aventis instructed doctors to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Patients should stop taking the drug in cases of suspected hepatic injury, the agency said. Such patients should undergo liver enzyme tests.

According to the FDA, the two cases of severe liver failure requiring transplantation occurred at 4.5 and 6 months after initiation of Multaq (dronedarone) in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age.

Multaq (dronedarone) was designed to be a safer alternative to amiodarone, a generic medicine with serious liver and lung risks that is only approved for life-threatening irregular beating in the heart’s lower chambers. According to a report from the Associated Press, Multaq (dronedarone) already carried a black box warning, the most severe type, stating the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used in those patients.

Since Multaq’s approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled Multaq (dronedarone) prescriptions at outpatient retail pharmacies in the U.S.

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