Multaq Liver Failure Case Highlighted in Medical Journal

A recently published case report examines the risk of liver failure from Multaq, a relatively new heart drug that has been linked to an increased risk of liver damage as well as potential heart problems. 

In the latest issue of the medical journal Circulation: Arrhythmia and Electrophysiology, a case study from Germany details how a 70 year-old woman began to suffer from liver problems after using Multaq, ultimately resulting in the need for a liver transplant.

According to the report’s authors, the woman did not smoke, drink or use drugs and she began showing signs of cirrhosis of the liver after Multaq use. She tested negative for hepatitis, hemochromatosis and HIV. She also tested negative for acetaminophen, the active ingredient in Tylenol which has been linked to liver damage as well.

Doctors determined that Multaq was the most likely cause based on the timing of the problems and the absence of other contributing factors. Nine days after the woman was hospitalized for liver problems she was suffering from an altered mental status and hepatic encephalopathy. She was then recommended for liver transplantation.

In January, the FDA warned about the potential risk of Multaq liver side effects, indicating that two patients on Multaq suffered acute liver failure that required them to get liver transplant. A couple weeks after that warning in the U.S., the FDA also sent a letter to Sanofi Aventis, admonishing the company for failing to pass on three adverse event reports involving Multaq side effects to the government.

A quarterly report by the Institute for Safe Medication Practices published the same month identified nine reported cases in the FDA adverse event database that linked Multaq use to serious liver damage and injury.

Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months. In less than two years since its approval, there have been at least 492,000 Multaq prescriptions in the United States filled by about 147,000 patients at outpatient pharmacies across the country. In addition, the drug can be given to patients being treated in hospitals.

In addition to liver damage fears, recently concerns have also been growing over the possibility of Multaq heart problems. In July, the FDA issued a drug safety communication announcing it was reviewing Multaq cardiovascular side effects. A similar review was also launched in Canada. 

Earlier this month, Sanofi-Aventis issued a letter to health care providers warning them that a clinical trial of Multaq was halted due to the high rate of cardiovascular death, strokes and heart failure that appeared to be associated with test subjects being given the drug. 

The study, known as PALLAS, was deemed too dangerous to those enrolled and two committees overseeing the safety of the study decided it would have been unethical to continue. More than 3,000 participants, all 65 years of age or older, were told to discontinue use of the drug for the treatment of permanent atrial fibrillation. Multaq is already approved to treat non-permanent atrial fibrillation.