Pradaxa® (dabigatran etexilate) contraindicated in patients with prosthetic heart valve replacement

Boehringer Ingelheim would like to update healthcare professionals that the use of Pradaxa® is now contraindicated in patients with prosthetic heart valve replacement. This contraindication is based on the recent analysis of data from the RE-ALIGN (A Randomised, Phase II study to Evaluate the sAfety and pharmacokinetics of oral dabIGatran exetilate in patients after heart valve replacement) trial, in which more thromboembolic events and bleeding events were observed with dabigatran etexilate. A summary of the trial results will be included in the product's packaging insert. Healthcare professionals are reminded to strictly follow the indications of Pradaxa®, and to refer to the package insert for full prescribing information.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.