gms | German Medical Science

10. Deutscher Kongress für Versorgungsforschung, 18. GAA-Jahrestagung

Deutsches Netzwerk Versorgungsforschung e. V.
Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e. V.

20.-22.10.2011, Köln

Drugs causing immune haemolytic anaemia: results from the Berlin Case-Control Surveillance Study (FAKOS)

Meeting Abstract

  • corresponding author presenting/speaker Elisabeth Bronder - Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Hanife Kurtal - Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Andreas Klimpel - Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Frank Andersohn - Institute for Social Medicine, Epidemiology and Health Economy, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Michael Thomae - Department of Surgery, Maria-Heimsuchung Caritas Klinik Pankow, Berlin, Germany
  • Hubert Schrezenmeier - University Hospital Ulm, Ulm, Germany
  • Martin Hildebrandt - Hannover Medical School, Hannover, Germany
  • Ernst Späth-Schwalbe - Vivantes Klinikum Spandau, Berlin, Germany
  • Andreas Grüneisen - Vivantes Klinikum Neukölln, Berlin, German
  • Beate Mayer - Institute for Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Abdulgabar Salama - Institute for Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • Edeltraut Garbe - Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Clinical Epidemiology, Bremen Institute for Prevention Research and Social Medicine, University of Bremen, Bremen, Germany

10. Deutscher Kongress für Versorgungsforschung. 18. GAA-Jahrestagung. Köln, 20.-22.10.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11dkvf064

DOI: 10.3205/11dkvf064, URN: urn:nbn:de:0183-11dkvf0645

Veröffentlicht: 12. Oktober 2011

© 2011 Bronder et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: Drug-induced immune haemolytic anaemia (DIIHA) is a rare but serious condition with an estimated incidence of 1 case/million/year. More than 130 drugs have been implicated as a cause, but reports are often incomplete.

Objectives: To characterize the spectrum of drugs associated with immune haemolytic anaemia (IHA) in the Berlin Case-Control Surveillance Study and to quantify the risk.

Material and Methods: Patients with incident IHA and control patients were ascertained through active surveillance in more than 50 Berlin hospitals (>180 clinical departments) between 2000 and 2009. Drug exposures/risk factors were ascertained in a standardized personal interview. IHA cases were characterized as acute, chronic or non-evaluable in a follow-up after >6 months. Drug relationship was assessed in a standardized causality assessment. Case-control analyses included IHA cases developed in outpatient care (all cases and excluding chronic cases). Odds ratios (ORs) and 95% confidence intervals (CI) were calculated using logistic regression analysis, adjusting for age, sex and other drugs with significant results.

Results: Of 134 validated cases of IHA, 59 cases were assessed as at least possibly drug related with a wide range of drugs implicated. Single drugs related to IHA in >3 cases with >1 certain/probable causality assessment included diclofenac, fludarabine, oxaliplatin, ceftriaxone, and piperacillin. In the case-control analysis of all 124 outpatient IHA cases and 731 controls, significantly increased risks were observed for beta-lactam antibiotics, cotrimoxazole, ciprofloxacin, fludarabine and lorazepam with ORs ranging from 5.3 for lorazepam to 22.2 for fludarabine. Drugs with a significant association in the case-control analysis of the 71 cases excluding chronic cases were similar. In this analysis, an increased risk was also apparent for diclofenac with an OR of 3.1 (95% CI, 1.3-7.0).

Conclusions: The spectrum of drugs associated with IHA in the standardized causality assessment in the Berlin Case-Control Surveillance Study is consistent with the spectrum of drugs reported in the literature. This is the first case-control analysis which quantifies the risk of IHA related to drugs.

The study was supported by a grant from the Federal Institute for Drugs and Medical Devices, Bonn, Germany.