Heart Drug Multaq Linked To Severe Liver Injury, Including Acute Liver Failure With Liver Transplant

In January 2011 FDA And Sanofi-Aventis Announce A Multaq Label Change With New Warning About Severe Liver-Related Side Effects

UPDATE:  On March 11, 2011 the FDA approved a change by Sanofi-Aventis to the Multaq Prescribing Information (also known as the package insert or label); there is a new warning about various types of liver injury in the "Warnings and Precautions" section.

Multaq (dronedarone) is a drug used to treat patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter). Multaq can reduce the risk of being hospitalized for these heart problems.

In January 2011 the FDA issued a "Drug Information Update - Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq)" that stated:

• There have been several case reports of liver injury and liver failure in patients treated with Multaq, including including two cases of acute liver failure requiring liver transplantation; and,

• There will be a revised Multaq label warning doctors about severe liver injury -- including drug-induced hepatitis, liver damage, liver failure, and liver transplants -- that have been associated with Multaq use.

This new information about the potential risk of liver injury from Multaq is being added to the "Warnings and Precautions" and "Adverse Reactions" sections of the Multaq label -- also called the Prescribing Information or the package insert.

Further, Sanofi-Aventis sent a so-called "Dear Doctor" letter to inform physicians and other healthcare professionals about the these severe drug-induced liver injury (DILI) side effects from Multaq use.

Back in 2009, when Multaq was approved by the FDA, it was recognized that Multaq could cause critical adverse reactions, including death, in patients with recent severe heart failure. Accordingly, the FDA required the original Multaq package insert, or label, to include a boxed warning which cautioned doctors that Multaq should not be used in severe heart failure patients.

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