Pradaxa (dabigatran etexilate) now licensed for use in the UK


Pradaxa (Boehringer Ingelheim) will be available in the United Kingdom as from 18 August 2011. This is the first new oral anticoagulant in over 50 years licensed for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation and one or more risk factors.

John Camm, head of the Department of Cardiac and Vascular Sciences, St. Georges Hospital, London, UK, commented, “Atrial fibrillation, is a very common problem affecting about 2% of the population. Often the first time someone finds out they have atrial fibrillation is when they have a stroke, which is a real disaster. About 50% of the patients who suffer from a stroke die from that stroke within the first few days or weeks and 50% of those who survive have some level of disability at six months. A new anticoagulant, like Pradaxa, is going to be very important for eligible atrial fibrillation patients.”

The recommended dose, Pradaxa 150mg twice daily, is licensed in the UK for the prevention of stroke and systemic embolism in eligible adult patients with atrial fibrillation. The granting of the licence follows the submission of data from the RE-LY trial the largest phase III stroke prevention in atrial fibrillation trial published to date involving 18,113 patients enrolled in 951 centres in 44 countries.

Pradaxa will provide clinicians with a new treatment option for stroke prevention in atrial fibrillation that does not require frequent coagulation monitoring, dose changes or routine adjustment and dietary restrictions. Like warfarin, Pradaxa can cause bleeding, with a higher risk of gastrointestinal bleeding and gastrointestinal symptoms than warfarin but a lower risk of intracranial haemorrhage. Clinical judgement should always prevail in the treatment of individual patients.

The European licence for Pradaxa was granted on 1 August 2011.