The European Medicines Agency has recommended restricting the use of Multaq. Multaq is an anti-arrhythmic medicine which is prescribed for maintaining heart rhythm in patientS with persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion.
Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only now be subscribed after alternative treatment options have been considered. The agency also recommended a number of other risk minimisation measures to reduce the risk of injuries to liver, lung and cardiovascular system.
Patients who are currently taking Multaq are recommended to have the treatment evaluated by their doctors at their next scheduled appointment.
Multaq (dronedarone) was authorised in 2009 for use in adults who have had atrial fibrillation in the past or who currently have non-permanent fibrillation.
A review of the overall balance of benefits and risks of Multaq was initiated in January 2011 because of reports of severe liver injury in patients treated with the medicine. On the basis of evaluations carried out the Agency has concluded that there was increased risk of Multaq causing liver injury as well as the lungs when used in accordance with the currently approved prescribing information. The CHMP stated that the benefits of Multaq outweighed its risks in 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 changes included –
- Treatment with Multaq should be restricted to patients with 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 Multaq should only be started and monitored by a specialist after other anti-arrhythmic medicines have been considered.
- Multaq must not be used in patients with permanent atrial fibrillation, heart failure or left ventricular systolic dysfunction (impairment of the left side of the heart).
- 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 which is another anti-arrhythmic medicine.
- Patients on Multaq should have their lung and liver function as well their heart rhythm regularly monitored.
If you have been taking Multaq and if you have suffered any of the above side effects you may be entitled to recover compensation for your injuries, please contact Liam Moloney, Solicitor, for further information about your rights on 045 898000 or simply log onto our website at www.moloneysolicitors.ie .
