Artikel
Drugs causing immune haemolytic anaemia: results from the Berlin Case-Control Surveillance Study (FAKOS)
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Autoren
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Elisabeth Bronder
- Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
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Hanife Kurtal
- Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
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Andreas Klimpel
- Centre of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Berlin, Germany
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Frank Andersohn
- Institute for Social Medicine, Epidemiology and Health Economy, Charité-Universitätsmedizin Berlin, Berlin, Germany
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Michael Thomae
- Department of Surgery, Maria-Heimsuchung Caritas Klinik Pankow, Berlin, Germany
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Hubert Schrezenmeier
- University Hospital Ulm, Ulm, Germany
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Martin Hildebrandt
- Hannover Medical School, Hannover, Germany
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Ernst Späth-Schwalbe
- Vivantes Klinikum Spandau, Berlin, Germany
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Andreas Grüneisen
- Vivantes Klinikum Neukölln, Berlin, German
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Beate Mayer
- Institute for Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
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Abdulgabar Salama
- Institute for Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
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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
| Veröffentlicht: | 12. Oktober 2011 |
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Gliederung
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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.
