Advice for prescribers
Multaq is now restricted to use in patients with paroxysmal or persistent atrial fibrillation (AF) following successful cardioversion only when alternative treatments are unsuitable.
It is contraindicated in patients with:
- permanent AF
- unstable haemodynamic conditions
- pulmonary or hepatic dysfunction caused by previous amiodarone treatment
- heart failure (previous or current)
- left ventricular dysfunction
For patients receiving Multaq, further renal and hepatic function monitoring is now required. Patients should be reviewed at their next routine appointment to confirm that continued treatment is appropriate and within the product licence.
The PALLAS study was terminated prematurely when interim analysis showed that dronedarone increased rates of heart failure, stroke and death from cardiovascular causes in patients 65 years of age and over with permanent AF and risk factors for major vascular events.
MHRA Drug Safety Update – October 2011