Direct Healthcare Professional communication: Pradaxa® (dabigatran etexilate) now contraindicated in patients with prosthetic heart valve requiring anticoagulant treatment

Source: Boehringer Ingelheim Limited Area: News Boehringer Ingelheim has issued this letter to reiterate that the use of Pradaxa® (dabigatran etexilate) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment. The existing warning in section 4.4 of the SPC not to use the drug in patients with prosthetic heart valves is strengthened to a contraindication based on the availability of new data from clinical trials.   The basis for this change is data from one investigational phase II trial and its extension trial in 252 patients examining dabigatran and warfarin use in patients with recent mechanical heart valve replacement surgery (i.e. within current hospital stay) and in patients who received a mechanical heart valve replacement more than three months ago. This patient population is different from those covered by the labelled indications. The study investigated a dose range from 150 mg twice daily to 300 mg twice daily with the majority of patients treated with a dabigatran ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news