Sanofi got its wish. The heart drug that's only been on the market since 2009 remains in circulation. But it does get a second black box Multaq warning for heart-related complications in patients suffering from atrial fibrillation.
The reprieve comes as a blow to critics who might have been hoping for a complete Multaq recall. However, in the end, most expected the FDA to allow Multaq to continue, while addressing the concerns over Multaq problems with beefed-up warnings.
According to a report by The Associated Press (AP), which was carried in various publications including The Boston Globe and Bismarck Tribune on December 20, the new FDA warning stems from a study done by Sanofi, which concluded that Multaq doubled the risk for heart-related complications in patients with permanent atrial fibrillation. The label revision, which was announced December 19, accents the approval of Multaq for short-term use only, in the treatment of atrial fibrillation and atrial flutter.
The Sanofi study found that Multaq contributed to higher rates of heart attack, stroke and even Multaq death in a subset of patients afflicted with the aforementioned heart conditions.
The FDA-mandated label update came three months after the European Medicines Agency (EMA) took similar precautions. The latter group has taken the position that Multaq dronedarone should only be used as a last resort.
AP reported that in a post-marketing study conducted by Sanofi, there were 25 deaths among a group of 3,200 study participants over the age of 65 with permanent atrial fibrillation, on Multaq dosing. Conversely, there were 13 deaths on the placebo group.
Multaq has been linked to various adverse reactions, including Multaq liver failure. However, it's the risk for heart events, stroke and Multaq death that formed the basis for the FDA warning this time. Doctors have been cautioned to check heart rhythms in their Multaq patients at least once every three months. If atrial fibrillation is found to be permanent, Multaq is to be discontinued.
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Sanofi countered with the observation that the study in question involved patients with severe heart failure, with many not at all afflicted with atrial fibrillation. A subsequent study involving 4,600 patients produced data that was more favorable.
Prior to December 19, Multaq already carried a black box warning for severe complications including Multaq death, in patients with recent severe heart failure.
In announcing the latest black box warning in December, the FDA signaled that it still believes Multaq to be a useful drug whose benefits outweigh the risks, in spite of the potential for Multaq heart failure, so long as it is used appropriately.