Multaq, Sanofi-Aventis’ $1 billion heart-drug, “should only be prescribed after alternative treatment options have been considered”, according to the European Medicines Agency (EMA).
In January 2011, the FDA issued a warning to patients with atrial fibrillation (abnormal heart rhythms) that the drug showed twice as many deaths as those who did not take the drug. This warning came as a result of a 3,000-patient trial that Sanofi-Aventis halted when they noticed an increased risk of cardiovascular events among patients with permanent atrial fibrillation.
The FDA is currently conducting a separate review and is expected to make a statement with regards to this trial soon.
In the meantime, it is advisable to follow the advice set out by the EMA. If you are currently taking Multaq (or dronedarone), you should have your treatment reassessed by your physician at your next scheduled visit.