Paris, FranceSanofi's heart-rhythm drug Multaq, has been given a new indication by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), essentially limiting the drug's use for safety reasons. The Food and Drug Administration (FDA) is expected to take similar steps shortly. Multaq, also know as dronedarone, has been associated with an increased risk of liver, lung, and cardiovascular adverse events.
Multaq is a medicine designed for use in people who suffer from a type of irregular heart beat called atrial fibrillation or A-fib. The new indication from the EMA now stipulates that Multaq should only be prescribed after "alternative treatment options have been considered." And, certain patients, such as those with current or previous episodes of heart failure, shouldn't not be prescribed the drug at all.
Multaq was approved in the United States in July 2009 for treatment of flutter and paroxysmal or persistent atrial fibrillation, but not permanent atrial fibrillation. Multaq was being studied in patients with permanent atrial fibrilliation in the PALLAS trial. When Sanofi found severe cardiovascular events occurring in some patients they stopped the trial early.
Multaq is also associted with reports of liver failure and in January the FDA and Sanofi warned of reports they had received of patients experiencing of acute liver injury while on the drug. However, the decision to halt the PALLAS trial was not related to liver-related adverse events.
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