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.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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