gms | German Medical Science

17th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

25.11. - 26.11.2010, Osnabrück

Systematic evaluation of drugs causing serious nephrotoxicity: preliminary data from the Berlin Case-Control Surveillance Study on Acute Kidney Injury of the Pharmacovigilance-Center FAKOS (PVZ-FAKOS)

Meeting Abstract

  • corresponding author Hanife Kurtal - Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Germany
  • Elisabeth Bronder - Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Germany
  • Andreas Klimpel - Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Germany
  • Harm Peters - Department of Nephrology, Charité-Universitätsmedizin Berlin, Germany
  • Edeltraut Garbe - Bremen Institute for Prevention Research and Social Medicine, University of Bremen, Germany; Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 17. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Osnabrück, 25.-26.11.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. Doc10gaa09

DOI: 10.3205/10gaa09, URN: urn:nbn:de:0183-10gaa094

Published: November 22, 2010

© 2010 Kurtal et al.
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Outline

Text

Introduction: The use of nephrotoxic drugs and diagnostic agents has been implicated as a causative factor in a quarter of all cases of acute kidney injury (AKI). The aim is to identify drugs and contrast media causing serious nephrotoxicity using data from the ongoing Berlin Case-Control Surveillance Study on Acute Kidney Injury.

Methods: Cases (patients ≥18 years of age having AKI requiring renal raplacement therapy) are recruited by an active surveillance involving 51 hospitals in Berlin, Germany. Information on exposure to drugs, herbal medicines, contrast media, and occupational exposures (e.g. chemicals) is obtained in a standardized individual interview and a medical documentation is filled in by the treating physician. The WHO causality assessment method is applied to each case to judge whether the AKI constituted an adverse drug reaction (ADR).

Results: Since April 2010, 26 cases (14 men, 12 women) of AKI with drug causality assessed as “probable” were included. Of those, 9 (34.6%) cases had previously normal renal function, whereas the 17 (65.4%) remaining cases had pre-existing kidney disease. 20 (76.9%) patients were ≥60 years of age. 24 different drugs were assessed as “probably” and 14 drugs as “possibly” related to AKI. The most frequently identified causative drugs assessed as “probable” were ACE inhibitors/angiotensin receptor blockers (ramipril, N=2; ramipril combined with hydrochlorothiazide, N=1; olmesartan, N=2; valsartan, N=1; valsartan combined with hydrochlorothiazide, N=1); chemotherapeutic/immunosuppressive agents (carboplatin, N=1; oxaliplatin, N=1; tacrolimus, N=1; bevacizumab, N=1); and antibiotics (vancomycin, N=2; clarithromycin, N=1). In 4 cases iodinated radiocontrast agents (iobidritol, N=3; iomeprol, N=1) and in 1 case glimepiride were involved.

Conclusion: Our preliminary data indicate that serious drug-induced AKI arises more frequently in the elderly, especially when pre-existing renal disease is present. As previously reported, ACE inhibitors and angiotensin receptor blockers as well as radiocontrast agents were often implicated. Unexpectedly, in one case Henoch-Schönlein purpura was probably induced by glimepiride.

Acknowledgement: PVZ-FAKOS is being funded by the Federal Institute for Drugs and Medical Devices, Germany.