The FDA said Multaq (dronedarone) is designed to treat atrial fibrillation or atrial flutter in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.
Since Multaq might cause critical adverse reactions, including death, in patients with recent severe heart failure, officials said Multag's drug's label will contain a boxed warning, the FDA's strongest warning, cautioning the drug should not be used by such people.
Multaq is manufactured by the French pharmaceutical company Sanofi-Aventis.
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