Following a full submission:
dronedarone (Multaq®) is accepted for restricted use within NHS Scotland.
Indication under review: in adult clinically stable patients with a history of, or current non permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.
SMC restriction: for the prevention of recurrence of AF in patients in whom beta-blockers, class 1c drugs or amiodarone are contra-indicated, ineffective or not tolerated. Treatment should be initiated on specialist advice only.
Dronedarone appears less effective than amiodarone in reducing atrial fibrillation recurrence but has the potential for improved tolerability compared to comparator medicines.
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Medicine details
- Medicine name:
- dronedarone (Multaq)
- SMC ID:
- 636/10
- Indication:
- For the treatment of atrial fibrillation
- Pharmaceutical company
- Sanofi-Aventis
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 13 September 2010
Since dronedarone was assessed by SMC in August 2010 there has been an important change to the therapeutic indication and the patient population in whom it is contraindicated. The new indication is “Dronedarone (Multaq) is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile dronedarone should only be prescribed after alternative treatment options have been considered. Dronedarone should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure”. Please refer to the current Summary of Product Characteristics for the most up to date information.