Europe Eyes Afib Drug Restriction
By Chris Kaiser, Cardiology Editor, September 22, 2011
Review
The European Medicines Agency (EMA) today recommended restricting the use of the antiarrhythmic drug dronedarone (Multaq) because of its adverse event profile.
The drug has been associated with an increased risk of liver, lung, and cardiovascular adverse events.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said dronedarone should be prescribed only for maintaining sinus rhythm after successful cardioversion in patients with paroxysmal or persistent atrial fibrillation or after alternative treatment options have been considered and rejected.
In January, the FDA said it would require a warning about the potential for liver injury added to the drug's label.
Then in July, drugmaker sanofi-aventis pulled the plug on the PALLAS trial because of an increase in cardiovascular events. PALLAS was testing dronedarone in patients with permanent atrial fibrillation, for which it is not approved.
The EMA committee initiated its review of the drug following reports of severe liver injury and the discontinuation of the PALLAS trial.
The committee acknowledged, however, that dronedarone remains a useful treatment option for some patients.
It also cautioned that the drug must not be used in patients with permanent atrial fibrillation, heart failure, or left ventricular systolic dysfunction and that doctors should consider discontinuation of treatment if atrial fibrillation reoccurs.
Patients on amiodarone should have regular monitoring of lung and liver function and heart rhythm. It's especially important to monitor liver function closely during the first few weeks of treatment, according to the committee.
The European Commission will consider the committee's recommendation.
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