Rare severe liver injury risk warning added to dronedarone labels


The FDA announced on 14 January 2011 that potential risk of liver injury has been added to the warnings, precautions and adverse reactions sections of dronedarone’s labels, due to several case reports of hepatocellular liver injury and hepatic failure and two cases of acute liver failure leading to liver transplant in patients treated with this heart medication.

The FDA approved dronedarone marketed as Multaq (Sanofi-aventis) in July 2009 to treat patients with atrial fibrillation or atrial flutter to reduce the risk of hospitalisation. According to the FDA, “Since dronedarone’s approval, from July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.”

Dronedarone was approved 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, the ones that were given dronedarone had a greater than two-fold increase in risk of death.

French pharmaceutical company, Sanofi-aAventis informed that no causal link has been established between taking the drug and acute liver failure.

The FDA advice patients who are on dronedarone to contact a healthcare professional whenever they experience hepatic injury or toxicity signs and symptoms such as: markedly reduced appetite, dark urine, fatigue, fever, jaundice, malaise, nausea and right upper quadrant pain.

The FDA is continuing to review reports of possible adverse events and drug interactions with dronaderone and suggests patients and healthcare professionals to report side effects and adverse events linked to this medication to the Agency’s MedWatch safety information and adverse event reporting programme that can be found on www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm