CHMP continues to monitor safety profile of Pradaxa (Boehringer) for VTE

The EMA has issued a safety update on VTE treatment Pradaxa/Rendix, from Boehringer. It reports that the Agency is aware of recent media interest regarding fatal cases of bleeding in patients treated with the drug, but the CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding. A worldwide total of 256 spontaneous case reports of serious bleeding resulting in death were recorded in the EudraVigilance database in association with the use of dabigatran, the active substance of Pradaxa. 21 out of these 256 cases were reported in the EU. It states that the number has to be seen in the context of the rapidly increasing use of Pradaxa worldwide as a result of approval of a new indication (prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation). The Agency will continue to closely monitor this issue and the overall safety profile of Pradaxa.