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Multaq: FDA Approved In July 2009 For Two Heart Rhythm Disorders, Atrial Fibrillation And Atrial Flutter

Original Package Insert, Or Label, Included "Black-Box" Warning In 2009; FDA Issues Drug Safety Alert About Liver Injury In 2011

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) was approved by the FDA in July 2009 to "help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter." These two types of heart rhythm disorders cause the heart to beat abnormally fast and, sometimes, prevent blood from being properly pumped out of the heart. Multaq is used as maintenance drug therapy in patients whose hearts have returned to normal rhythm, or who will undergo drug or electric-shock treatment to correct the irregular heart rhythm and restore a normal heart beat.

Multaq is manufactured by the drug company Sanofi-Aventis, based in Paris, France.

The original Multaq package insert, or label, from 2009 included a so-called "black-box" warning (also called a boxed warning), the FDA's strongest safety warning, which cautioned doctors that Multaq should not be used in severe heart failure patients.

In January 2011 the FDA issued a drug safety alert for Multaq concerning severe liver injury, such as liver failure requiring liver transplantation, associated with Multaq use.


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