Sales of the popular heart-rhythm drug Multaq (dronedarone) have been severely restricted by European regulators amidst safety concerns involving serious liver and lung injuries. In response to the new information regarding Multaq side effects, the U.S. Food & Drug Administration (FDA) is soon expected to follow Europe’s lead in restricting use of the drug. The Multaq lawyers at Schmidt & Clark, LLP are currently accepting potential lawsuits nationwide on behalf of victims injured by Multaq side effects.
What’s the problem?
Multaq is intended for use in patients with a form of irregular heartbeat known as atrial fibrillation (A-fib). In its announcement, the European Medicines Agency (EMA) stated that Multaq should not be prescribed to individuals whose heartbeat is permanently askew, but that the drug would remain on the market for certain patients with a less severe form of the condition.
Millions of people around the country suffer from A-fib, whose short-term symptoms may include episodes of faintness and shortness of breath. Over the long-term, untreated A-fib may significantly elevate the risk of stroke. The condition is typically treated with blood-thinning drugs, devices to alter the heartbeat, and with medications like Multaq that can return the heart to its normal rhythm.
The EMA stated that physicians should consider alternative courses of treatment before turning to Multaq. The agency reportedly found that “… there was an increased risk of Multaq causing injury to the liver as well as the lungs when used in accordance with the currently approved prescribing information.”
Two independent studies conducted by the manufacturer of Multaq, Sanofi-Aventis, have found high death rates in certain patients and cast serious doubt about the drug’s future.
Here at home in the United States, federal regulators are in the process of scrutinizing data that will hopefully enable them to understand which Multaq patients might be helped by the drug, and which might be injured or killed. The FDA has requested that Sanofi turn over results from two clinical trials in which Multaq was linked to an increased risk of stroke and death.
In the first study, patients with a temporary form of the condition known as ‘persistent A-fib’ were hospitalized less frequently for cardiac conditions if they were being treated with Multaq. The other study looked at patients with ‘permanent A-fib,’ which tends to be much more severe. The FDA is attempting to determine the percentage of persistent A-fib patients that were harmed by Multaq, as well as what happens to patients in the gray area – those with A-fib on the verge of being permanent.
In 2009, the FDA placed a ‘black box’ warning – the strictest allowed by law – on labels of Multaq, stating that the sickest patients with advanced heart failure should not be prescribed the drug.
The controversy surrounding Multaq has significantly affected sales of the drug. Once thought to have potentially billions of dollars in annual sales, Multaq generated less than $180 million in the first half of 2011.