FDA updates label safety warning for Multaq (Sanofi-Aventis) - 20-Dec-2011
The FDA adds new safety warnings to the label of Multaq (dronedarone), from Sanofi-Aventis, after studies revealed the drug doubles the rate of cardiovascular death, stroke, and heart failure in patients with permanent Atrial Fibrillation. The revised labelling stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. The update is based on data gathered from the PALLAS and ATHENA trials.
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