Controversial, Experimental Drug May Decrease Hospitalizations Due to Irregular Heartbeats, FDA Says

An experimental drug made by Sanofi-Aventis may dramatically cut hospitalizations caused by irregular heart rhythms, according to the Food and Drug Administration.

The maker of Multaq, also called dronedarone, is seeking FDA approval of the drug for treatment of atrial fibrillation, in which the upper chamber of the heart fail to beat effectively, causing blood clots. A preliminary decision on Multaq is expected this week, when an advisory panel of cardiologists gives its opinion to the FDA on whether the drug is efficient and safe. The FDA is not required to follow the advice of the panel.

Multaq has a checkered past at the FDA and was rejected by the agency in 2006 after a study found that the drug was linked to higher death rates among patients with severe heart failure.

Recent Study Encouraging

However, more recent studies of patients with less serious heart problems have shown the drug may significantly reduced the need for hospitalization due to atrial fibrillation, the FDA said.

One trial including more than 4,600 patients also showed Multaq slightly reduced the risk of death, but the amount was so slight that some in the FDA have said they do not claim the drug can actually lower the risk of death.

It is possible that if approved by the FDA for the treatment of atrial fibrillation, Multaq would not be recommended for patients who have suffered severe heart failure, officials said.

A New Treatment for a Growing Problem

Multaq would be the first new medication for treatment of atrial fibrillation in more than 25 years. Other drugs for treatment of the disease, including amiodarone which is sold under the names Cordarone and Pacerone, can cause breathing complications and other significant side effects.

About 15 percent of strokes are caused by atrial fibrillation, according to the American Heart Association, and it is becoming more common, with the number of patients affected by the condition expected to double by 2050.

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