US FDA warns on acute liver failure with Sanofi-Aventis Multaq

The US Food and Drug Administration on Friday notified health care 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 French drug major Sanofi-Aventis’ (Euronext: SAN) anti-arrythmic Multaq (dronedarone). Information about the potential risk of liver injury from dronedarone is being added to the Warnings and Precautions and Adverse Reactions sections of the dronedarone labels, the agency said.

Paris-based Sanofi -Aventis, which saw its shares dip 1.2% to close at 51.20 euros on Friday, told Dow Jones that it had sent a letter to health care providers in the USA about the case. Company spokesman Jean-Marc Podvin said: "Patient safety is Sanofi's priority,” and the company is also "working with European health authorities and in the countries where Multaq is approved and those where it is submitted for review." The letter recommends prescribers to consider giving liver enzyme tests during the first six months of treatment.

Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm during the past six months. In July 2009, dronedarone was approved by the FDA with a Risk Evaluation and Mitigation Strategy (REMS) 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 dronedarone had a greater than two-fold increase in risk of death.