Re-issued: December 2012
Following safety concerns, the European Medicines Agency (EMA) has amended the marketing authorisation for dronedarone (see EMA website 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.
Who can have dronedarone?
You should be able to have dronedarone if:
- you have already tried another type of drug (usually a drug called a beta-blocker) but this has not worked and other options have been considered and
- you have at least 1 of the following which means you are at a higher risk of developing disease of the heart or blood vessels:
- you are taking at least 2 different types of drugs for high blood pressure
- you have diabetes
- you have had a type of stroke or a blood clot in the past
- the left chamber of your heart is larger than normal or
- you are 70 or over and
- you do not have problems with the left side of the heart pumping properly (a condition called left ventricular systolic dysfunction) and
- you do not have heart failure and you have not had heart failure before.
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.
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.