The heart drug Multaq has been associated with cases of severe liver damage -- including at least two cases in which patients suffered acute liver failure and required transplants -- the U.S. Food and Drug Administration has announced.

Also, a randomized trial found increased cardiovascular events associated with Multaq among patients with permanent atrial fibrillation (an unapproved use of the drug) and its manufacturer in July 2011 acknowledged a risk for patients with “vascular risk factors.”

Kline & Specter, PC, based in Philadelphia, with 50 lawyers, several of whom are also highly regarded doctors (See Doctor/Lawyer Team), is uniquely qualified to investigate and litigate pharmaceutical injury cases. However, at this time, we are no longer accepting cases involving liver damage caused by Multaq.

Patients using Multaq/dronedarone, which is used to treat irregular heartbeat, were warned to contact their doctors if they develop symptoms of liver injury, which can include yellow eyes or skin, dark urine, itching, loss of appetite, vomiting, fever, fatigue and right upper quadrant pain.

The FDA said cases of liver damage associated with the use of Multaq, or dronedarone, were “rare but severe.” The two reported cases that necessitated transplants both involved women about 70 years old. One woman had used Multaq for six months and the other for about four and a half months. Both had had normal hepatic serum enzymes before they began taking Multaq/dronedarone. The maker of the drug, Sanofi-Aventis SA, would not immediately say where the women resided.

In December 2011, the FDA said it had completed a safety review that showed Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation. For these types of patients, Multaq was found to double the rate of cardiovascular death, stroke and heart failure. (See the FDA news release)

Dronedarone was approved by the FDA in July 2009 and about than 500,000 prescriptions have since been written for the drug, including for 117,000 patients in the United States. Sanofi is based in France and has a U.S. headquarters based in Bridgewater, New Jersey.

See the FDA Safety Warning on Multaq/dronedarone