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Case of severe liver injury after treatment with Multaq ® - Press

Several cases of liver damage, including two cases of hepatic failure requiring transplantation in patients treated with Multaq ® were observed. This drug is authorized by a European since November 2009. It is marketed in France since late October 2010. Multaq ® is indicated in cases of cardiac arrhythmias. AFSSAPS indicates that patients treated with Multaq ® will be contacted by the doctor who follows them for a liver within a month of this information. AFSSAPS recommends that they immediately report to their physician any symptoms of liver damage. Health professionals concerned will receive in the next few days an email or a letter informing them of pharmacovigilance data, and specifying the conduct to take vis-à-vis their patients.

Multaq ® (dronedarone) is indicated in cases of cardiac arrhythmias in adult patients (history of atrial fibrillation or atrial fibrillation currently non-permanent). Cons-It is reported in many cardiovascular diseases and in cases of severe liver disease.
This drug has a European approval for placing on the market since November 2009 (Sanofi-Aventis). It is submitted from this date on a European Risk Management (PMP) and is monitored on a national pharmacovigilance. Several
cases of liver damage have been reported in patients treated with Multaq ®, some occurred very quickly after starting treatment. Two cases of liver failure, reported in Germany and the United States, required a transplant.
These recent pharmacovigilance data will be integrated with the summary of product characteristics and package leaflet of the drug.
AFSSAPS recommends that health professionals involved to get in contact in the months following this information with their patients currently under treatment with dronedarone for the realization of a liver. He also asked these professionals to: * Perform

liver function before initiating treatment with dronedarone and every month for 6 months and 9 months and 12 months and regularly thereafter.

* Check in 48 to 72 hours the rate of ALT (alanine aminotransferase) they are greater than or equal to three times the legal limit. If confirmed after inspection, treatment should be discontinued and lead to closer clinical monitoring of patients and implementation of exploration until the normalization of ALT.

advised patients to immediately report to their physician any symptoms of liver damage potential such as abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching.
In agreement with the European Agency and Afssaps, Sanofi-Aventis laboratories will disseminate these new recommendations to healthcare professionals concerned will receive in the next few days by mail or courier.

Press Contacts: presse@afssaps.sante.fr
Axelle de Franssu - 01 55 87 30 33 / Magali Rodde - 01 55 87 30 22

afssaps.fr