Boehringer Ingelheim updates safety info for Pradaxa related to heart valve

The US subsidiary of German independent drug major Boehringer Ingelheim says that the US prescribing information for its blood thinner Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

The decision to add the contraindication was made following an interim analysis of results from the Phase II RE-ALIGN study in patients with mechanical prosthetic heart valve replacement, a patient population different than the currently labeled indication for Pradaxa. The RE-ALIGN study did not enroll any US patients. The interim analysis showed an increased incidence of thromboembolic and bleeding events in this specific patient population treated with dabigatran etexilate compared to warfarin.

The move follows an FDA announcement that it is informing health care professionals and the public that the anticoagulant Pradaxa should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.