Multaq: First New Atrial Fibrillation Drug Approved in 25 Years
The Food and Drug Administration today approved Multaq for patients with atrial fibrillation and atrial flutter, making it the first medication for treatment of the heart rhythm disorders to be approved in 25 years.
Multaq, known generically as dronedarone, comes in tablet form and is used to help patients whose hearts have returned to normal rhythm or who will undergo electric-shock or drug treatment to restore normal heart beat. The drug is made by French pharmaceutical firm Sanofi-Aventis.
About 15 percent of strokes are caused by atrial fibrillation and the number of people who suffer strokes caused by the condition is expected to double by 2050, according to the American Heart Association. In atrial fibrillation and atrial flutter, the heart beats abnormally fast, a condition which can prevent blood from being properly pumped out of the heart.
“Multaq represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
Controversial Drug is Approved
Earlier this year, an FDA report found that Multaq significantly reduced the number of hospitalizations for irregular heart rhythms. In a study of more than 4,600 patients, Multaq was associated with a 24-percent reduction in hospitalizations and deaths due to atrial fibrillation and other cardiovascular complications when compared to inactive placebo pills.
But the drug is not without controversy.
Some clinical studies of the drug found that Multaq resulted in higher death rates when given to patients with history of severe heart failure. In approving the drug, the FDA noted that Multaq can result in life-threatening adverse reactions in patients with recent severe heart failure. As a result, Multaq’s packaging will carry a prominent “Black Box” warning to alert physicians and patients of the risk, the FDA said.
A black box warning is the strongest such alert the FDA can order be added to a drug’s packaging.
Common side effects of Multaq include diarrhea, nausea, vomiting, fatigue and loss of strength.
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