EMA says bleeding risks associated with Boehringer Ingelheim's Pradaxa can be managed

The European Medicines Agency on Friday providing an update on the safety of independent German drug major Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate) saying that, with the current warnings, the side effects of the drug are manageable.

Pradaxa has been authorized since March 2008 for primary prevention of venous thromboembolic events in adults who have had elective total hip replacement surgery or total knee replacement surgery. Since August 2011, it is also authorised for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. The efficacy of Pradaxa as demonstrated in clinicial trials remains unchanged.

The Agency says it is aware of recent media interest regarding fatal cases of bleeding in patients treated with Pradaxa. The risk of bleeding with anticoagulant medicines is well-known. For Pradaxa, this has been reflected since its initial marketing authorization in the approved European Union product information, which recommends that doctors check for signs of bleeding and discontinue treatment in patients with severe bleeding. Pradaxa is contraindicated in a number of conditions, including in patients who are bleeding and patients with severe renal impairment, and it should be used with caution and at lower doses in elderly patients and patients with moderate renal impairment (depending on indication and circumstances).