Importance of assessing renal function in patients treated with Pradaxa® (dabigatran etexilate)

Boehringer Ingelheim would like to inform healthcare professionals of new recommendations to assess renal function in patients being treated with or being considered for treatment with Pradaxa®. Although the rate of reported suspected fatal bleeding associated with Pradaxa® as of 31 October 2011 is lower than the fatal bleeding incidence of 230 events per 100,000 patient years seen in the key pre-market clinical study evaluating the efficacy of Pradaxa®, RE-LY, these new recommendations have been issued to mitigate the risk of serious bleeding events arising from the use of Pradaxa® in patients with varying degrees of renal impairment.The recommendations include renal assessment through creatinine clearance calculation prior to initiation of Pradaxa® treatment, on-treatment renal assessment in cases of suspected renal function deterioration as well as annual on-treatment renal assessment for the elderly and patients with moderate renal impairment. The package insert of Pradaxa® will be updated with the relevant information.