Overview
Evidence-based recommendations on dronedarone (Multaq) for treating non-permanent atrial fibrillation in adults.
These recommendations are included in NICE guideline CG180.
Last reviewed: 1 December 2012
Following safety concerns, the European Medicines Agency (EMA) has amended the marketing authorisation for dronedarone (see EMA webpage on dronedarone [Multaq]) for details of the decision and the revised marketing authorisation). The therapeutic indication of the revised marketing authorisation is now more restricted than that originally appraised in NICE technology appraisal guidance 197. For more information, see the summary of product characteristics for dronedarone.
There is no new evidence to indicate that dronedarone would be less safe or less effective in the population covered by the revised marketing authorisation. The wording of recommendation 1.1 in NICE technology appraisal guidance 197 has been amended to reflect the changes in the UK marketing authorisation.
NICE recommends dronedarone as a possible treatment for some people with non-permanent atrial fibrillation who have had a procedure called cardioversion to correct an irregular heart rhythm.
Next review: This guidance will be reviewed if there is new evidence that is likely to change the recommendations.
Guidance development process
How we develop NICE technology appraisal guidance
Your responsibility
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.