December 19th, 2011

FDA Adds New Warnings to Dronedarone (Multaq) Label

In an updated safety communication, the FDA announced on Monday that it is adding new warnings  to the dronedarone (Multaq, Sanofi) label. On the basis of results from the PALLAS trial, which was discontinued early due to safety concerns, the drug label will now warn:

Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.

In addition, the label will state that people taking dronedarone should have an ECG every 3 months. The drug should be stopped if a patient is found to be in AF or, if clinically indicated, the patient should undergo cardioversion.

The FDA also performed a new analysis of the ATHENA trial, which included only patients with non-permanent AF, and which formed the basis for the drug’s approval and labeling. The analysis reaffirmed the benefits of dronedarone in ATHENA, finding that the drug reduced hospitalizations and was not associated with an increased risk of cardiovascular death, stroke or heart failure.

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