The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia.
This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.
The European Medicines Agency recommends that the medicine is only used for maintaining a normal heart rate (sinus rhythm) in patients treated for attacks of atrial fibrillation or persisten fibrilation (rapid irregular and changing contractions of the atenterior chambers). Multaq® should not be used in patients with atrial fibrillation not converted to normal (sinus) rhytm or in patients suffering from cardiac insufficiency (reduced pumping function).
Moreover, Multaq® treatment should only be initiated after other preventive treatment has been considered or attempted. The reason for this is that the medicine increases the risk of effects on liver, lungs, heart and vessels.
Patients using Multaq® should consult their GP to determine their future treatment at their next scheduled appointment with the GP.
The European Medicines Agency also recommends a number of other measures to minimise the risk of side effects. For instance, treatment with Multaq® should only be given and monitored by a cardiologist, and patients should have their lung and liver function and heart rate checked regularly.