FDA Further Restricts Use of Sanofi (France)'s Multaq

Published: Dec 21, 2011

Federal health officials said Monday they have added new safety warnings to the heart rhythm drug Multaq, after a company study by Sanofi linked the tablet to higher rates of heart attack, stroke and death in a subset of patients.The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart’s chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the Food and Drug Administration.

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