The EMA has recommended restricting the use of Multaq (dronedarone) due to an increased risk of liver, lung and cardiovascular adverse events.
The CHMP made the decision following the outcome of a terminated clinical trial and other data which highlighted the cardiovascular safety of the medicine and the risk of damage to the lungs.
The Committee now advises Multaq be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion.
As part of the review, the CHMP was informed about the early termination of the PALLAS study due to the occurrence of several cardiovascular side effects in patients taking the medicine.
The study analysed the use of Multaq when compared to placebo in patients aged 65 and above with permanent atrial fibrillation and several risk factors. Although the anti-arrhythmic medicine has not been approved for this patient population, the CHMP had concerns about the outcome of the study and then extended its review analysing data about the cardiovascular safety and risk to the lungs.
But despite its decision, the Committee says it was conscious about the range of treatments available and that for patients with non-permanent atrial fibrillation “Multaq remains a useful treatment option”.
In these patients the CHMP says that Multaq continues to outweigh its risks, but has made a number of recommendations on its future use to minimise the risk of injury to the liver, lung and heart.
- Treatment should be restricted to patients with paroxysmal or persistent atrial fibrillation when sinus rhythm has been obtained.
- Treatment should only be started and monitored by a specialist after other anti-arrhythmic medicines have been considered.
- It 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.
- Multaq must not be used in patients who have had previous liver or lung injury following treatment with amiodarone, another anti-arrhythmic medicine.
- Patients should have their lung and liver function as well as their heart rhythm regularly monitored.
The CHMP’s recommendations have now been passed on to the European Commission for the adoption of a decision.
Multaq has been in the EU since November 2009.