September 22, 2011 — After linking Multaq (generic: dronedarone) with increased risks of life-threatening liver and lung injury, a European regulation group is limiting use of the heart-rhythm drug for safety reasons. According to experts, the U.S. Food and Drug Administration (FDA) is expected to follow suit in upcoming weeks.
The European Medicines Agency recommended today that Multaq should only be used as a therapy treatment for patients who have intermittent forms of atrial fibrillation, or A-fib, as the drug has been proven too dangerous for use in other A-fib patients.
A-fib is a form of irregular heartbeat that can elevate the risk of stroke. Short term, it can also cause faintness and shortness of breath. Manufactured by Sanofi-Aventis, Multaq is one drug used to treat A-fib. Multaq returns the heart to normal rhythm.
Yet, two studies by the manufacturer have suggested high death rates associated with the drug, as well as increased risks of liver and lung failure. As the European agency said:
“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.”
In 2009, the FDA even placed a box warning on the Multaq label, advising sick patients with advanced heart failure — particularly those who had just been hospitalized for cardiac reasons — to avoid Multaq.
With millions of people suffering from A-fib, the European agency recommends doctors consider other treatments first before turning to Multaq. Other treatment options include blood-thinning drugs, devices to alter the heartbeat, and generic forms (like amiodarone) of drugs similar to Multaq, that also return the heart to normal rhythm.
Yet, the European agency admits there may be benefits for Multaq use in a certain number of A-fib patients who only have intermittent forms of the disease.
US regulators with the FDA are currently evaluating data that will allow them to better decide which patients may be helped with Multaq therapy, and which patients may be seriously injured or killed by the drug. In particular, the FDA is asking Sanofi for details on the patients from two clinical trials.
One of these clinical trials found patients with temporary forms of A-fib, known as the “persistent” form, tended to be hospitalized less if using Multaq. The other study evaluated Multaq’s effectiveness in patients with the permanent and more serious form of A-fib.
Based upon the agency’s findings, the FDA will have to conclude if the benefits of Multaq outweigh the risks. Specifically, the FDA will have to decide if Multaq provides an overall benefit to patients or if it harms more than 10% of users. The agency will also have to evaluate more definitively what happens to patients that fall in the gray area between a temporary and permanent A-fib condition, and if Multaq is a suitable treatment option for them.
With reports of Multaq-related health risks continuing to increase, the medication has dropped from a billion-dollar-a-year drug to generating sales of just $179 million so far in 2011.