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Thursday, September 22, 2011

European Medicines Agency Recommends Restricting Use of Dronedarone

LONDON -- September 22, 2011 -- The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of dronedarone (Multaq).

The anti-arrhythmic medicine should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion. Due to an increased risk of liver, lung, and cardiovascular adverse events, dronedarone should only be prescribed after alternative treatment options have been considered.

The Committee also recommended a number of other risk minimisation measures to reduce the risk of injuries to liver, lung, and cardiovascular system.

The review of the overall balance of benefits and risks of dronedarone was initiated in January 2011 because of reports of severe liver injury in patients treated with the medicine.

During the review, the CHMP was informed of the early termination of a clinical trial (PALLAS study) due to the occurrence of severe cardiovascular side effects such as cardiovascular death, stroke, and cardiovascular hospitalisation in patients taking the medicine.

The PALLAS study investigated the use of dronedarone compared with placebo in patients aged older than 65 years with permanent atrial fibrillation and several risk factors.

Although dronedarone has not been approved for this patient population, the CHMP was concerned about the outcome of the PALLAS study and extended its review to also look at the data relating to cardiovascular safety of the medicine as well as other data that became available on the risk of damage to the lungs.

On the basis of the evaluation of the currently available data, the Committee concluded that there was an increased risk of dronedarone causing injury to the liver as well as the lungs when used in accordance with the currently approved prescribing information. The Committee also considered that the cardiovascular events shown in the population in the PALLAS study could mean an increased risk of cardiovascular side effects for some patients with non-permanent atrial fibrillation.

However, the Committee considered that the availability of a range of treatments for a difficult condition such as atrial fibrillation was important and that for some patients with non-permanent atrial fibrillation dronedarone remains a useful treatment option. The CHMP therefore was of the opinion that the benefits of dronedarone outweigh its risks in these patients, provided that further changes to the information for prescribers and patients will be introduced to minimise the risk of injury to the liver, lung and heart. These include:
· Treatment with dronedarone should be restricted to patients with paroxysmal or persistent atrial fibrillation when sinus rhythm has been obtained. It is no longer indicated for use in patients when atrial fibrillation is still present.
· Treatment with dronedarone should only be started and monitored by a specialist after other anti-arrhythmic medicines have been considered.
· Dronedarone must not be used in patients with permanent atrial fibrillation, heart failure or left ventricular systolic dysfunction.
· Doctors should consider discontinuation of treatment if atrial fibrillation reoccurs.
· Dronedarone must not be used in patients who have had previous liver or lung injury following treatment with amiodarone, another anti-arrhythmic medicine.
· Patients on dronedarone should have their lung and liver function as well as their heart rhythm regularly monitored. Especially the liver function should be closely monitored during the first few weeks of treatment.

The Committee’s opinion has now been forwarded to the European Commission for the adoption of a decision.

SOURCE: European Medicines Agency

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