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EMA warnings follow dronedarone liver damage

Following two case reports of severe liver damage ultimately requiring transplantation in patients taking dronedarone (Multaq®, sanofi-aventis), the European Medicine’s Agency (EMA) has recommended changes to the product information encouraging close monitoring of liver function.[1] The announcement was made at the EMA’s monthly Committee for Medicinal Products for Human Use (CHMP).

reading2The Committee noted that although the two patients requiring a liver transplant were also taking other medications, a causal relationship with dronedarone could not be excluded. The EMA therefore recommended that warnings and precautions be introduced into the medicine’s prescribing information, to ensure that patients’ liver function is tested before initiation of treatment, closely monitored during treatment, and treatment is stopped if there are signs of potential liver damage.

The Committee also suggested that sanofi-aventis provide a letter to healthcare professionals[2] (full text available: explaining the new recommendations for use. The letter cites the EMA’s recommendations that, for patients prescribed dronedarone, liver function tests should be performed prior to treatment, on a monthly basis for six months, again at months 9 and 12, and periodically thereafter. Prescribers are reminded that the drug is contraindicated in patients with severe hepatic impairment, while patients currently receiving it are to be contacted and monitored as above.

Reports of liver function test abnormalities and hepatocellular liver injury have emerged around dronedarone since it was licensed in 2009. The two case reports of liver transplantation occurred at 4.5 and 6 months after inititation of treatment in patients with normal baseline liver function tests. In one case the liver injury was not reversible after discontinuation of dronedarone.

Further general information on dronedarone, including clinical trials, can be found at:


  1. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17th-20th January 2011 – read online
  2. Information on severe liver injury associated with the use of Multaq (dronedarone), Sanofi-aventis letter

Full text:

Published on: February 2, 2011

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