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.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.