Multaq (dronedarone) licence restricted owing to safety concerns

Prescribing information for Multaq (dronedarone) has been updated following a review of preliminary safety data from the PALLAS study and postmarketing reports of liver and pulmonary toxicity.

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.

Clinical study

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