Pradaxa practice test could prevent deaths

Patient-related measurement of the new anticoagulant Pradaxa as a potential contribution to the prevention of deaths

11/14/2011

Boehringer Ingelheim's new anticoagulant Pradaxa has been associated with 256 deaths, after it was approved nearly 2 months ago almost worldwide for the prophylaxis of stroke and other vascular occlusions in patients with atrial fibrillation. This resulted in a demand of the weekly „The mirror“ at the European Medicines Agency European Medicines Agency published on 12 November 2011 in the online edition.

In Europe this affected 21 patients and of these 4 in Germany. As Pradaxa is excreted approximately 85 percent through the kidney, a restriction of renal function (creatinine clearance less than 30ml / min) is a contraindication. The blood levels of Pradaxa increase in renal failure and thus the risk of life-threatening bleeding. Böhringer Ingelheim therefore recommends the determination of creatinine in the blood of patients before and while taking Pradaxa. From the same blood sample, the concentration of Pradaxa can be determined easily and within 30 minutes (British Patent Application Number H3393GB). With a method close to the patient, Pradaxa can also be detected in the urine. If Pradaxa is excreted less in the urine in a restriction of renal function, its concentration in the blood increases and thus the risk of serious and fatal bleeding.

Evidence may show the result of color development by physicians, nurses, patients' relatives and even within 15 minutes (the same British patent application). The tests are not yet commercially available, but can be performed by the inventors from existing blood samples or requested as a test for the urine. The timely detection of Pradaxa in blood or urine could therefore contribute to the prevention of bleeding with fatal consequences in the future. (Prof. Dr. med. Job Harenberg Clinical Pharmacology, University of Mannheim)

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Picture: Gerd Altmann