The manufacturer of dabigatran (Pradaxa®) has written to healthcare professionals advising of new recommendations relating to the assessment of renal function in patients who are being considered for or who are already taking this drug.
This new advice follows reports of fatal bleeding events in Japan, some of which occurred in elderly patients with severe renal impairment.
It is now recommended that:
- Renal function is assessed in all patients prior to initiating treatment
- Dabigatran is contraindicated in patients with severe renal impairment (creatinine clearance less than 30ml/min)
- Renal function should be reassessed where declines are suspected (hypovolaemia, dehydration)
- Patients over 75 years of age and those with existing renal impairment should have annual checks of renal function
Action: Clinicians should be aware of these monitoring requirements. The place of dabigatran in therapy, compared to warfarin, is still being debated; these new recommendations may need consideration as part of that debate.
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