{"id":11975,"date":"2011-09-22T13:32:06","date_gmt":"2011-09-22T17:32:06","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=11975"},"modified":"2011-09-22T13:32:06","modified_gmt":"2011-09-22T17:32:06","slug":"dronedarone-multaq-gets-another-drubbing-in-europe","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/09\/22\/dronedarone-multaq-gets-another-drubbing-in-europe\/","title":{"rendered":"Dronedarone (Multaq) Gets Another Drubbing in Europe"},"content":{"rendered":"

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended new restrictions on dronedarone (Multaq)<\/a>, Sanofi’s embattled and controversial antiarrhythmic drug. CHMP says that dronedarone should only be used for maintaining sinus rhythm in patients with paroxysmal or persistent AF after successful cardioversion. The drug should no longer be used in patients who still have AF, CHMP says.<\/p>\n

Because dronedarone increases the risk for liver,\u00a0lung, and cardiovascular adverse events, CHMP adds that it should be used only after alternative treatments have been considered. People already taking dronedarone should “have their treatment evaluated\u00a0by their doctor at their next scheduled appointment.”<\/p>\n

CHMP and the FDA began their reviews of dronedarone<\/a>\u00a0in January of this year after receiving reports of severe liver injury in people taking the drug. The review was broadened in July\u00a0when the PALLAS trial of dronedarone for the treatment of permanent AF was terminated early<\/a>\u00a0due to a significant increase in cardiovascular events in the dronedarone arm of the trial.<\/p>\n

In its review, CHMP concludes that dronedarone increases the risk for injury to the liver and the lungs and may increase the risk for cardiovascular side effects in some patients with nonpermanent AF. However, CHMP affirms that for some patients with nonpermanent AF, the drug “remains a useful treatment option” and that its benefits outweigh its risks for these patients.<\/p>\n

CHMP also recommends that:<\/p>\n