Hematological safety of metamizole: retrospective analysis of WHO and Swiss spontaneous safety reports

Blaser, Lea S. and Tramonti, Alexandra and Egger, Pascal and Haschke, Manuel and Krähenbühl, Stephan and Rätz Bravo, Alexandra E.. (2015) Hematological safety of metamizole: retrospective analysis of WHO and Swiss spontaneous safety reports. European journal of clinical pharmacology, 71 (2). pp. 209-217.

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Official URL: http://edoc.unibas.ch/dok/A6337918

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Since the 1970s, the use of metamizole is controversial due to the risk of agranulocytosis. The aim of this study was to analyze individual case safety reports (ICSRs) of metamizole-associated hematological adverse drug reactions (ADRs).; International and Swiss metamizole-associated ICSR concerning selected hematological ADR were retrieved from VigiBase™, the World Health Organization Global Database of ICSR, and the Swiss Pharmacovigilance Database. We evaluated demographic data, co-medication, drug administration information, dose and duration of metamizole treatment, as well as the latency time of ADR, their course, and severity. The subgroup analysis of Swiss reports allowed us to analyze cases with fatal outcome more in depth and to estimate a rough minimal incidence rate.; A total of 1417 international and 77 Swiss reports were analyzed. Around 52 % of the international and 33 % of the Swiss metamizole-associated hematological ADR occurred within a latency time of ≤7 days. More women were affected. The annual number of hematological reports and those with fatal outcome increased over the last years parallel to metamizole sales figures. In Switzerland, the minimal incidence rate of agranulocytosis was 0.46-1.63 cases per million person-days of use (2006-2012). Female sex, old age, pancytopenia, and co-medication with methotrexate were striking characteristics of the seven Swiss fatal cases.; Metamizole-associated hematological ADR remain frequently reported. This is underscored by increasing annual reporting rates, which mainly reflect growing metamizole use. Early detection of myelotoxicity and avoidance of other myelotoxic substances such as methotrexate are important measures for preventing fatalities.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Ehemalige Einheiten Pharmazie > Pharmakologie (Krähenbühl)
UniBasel Contributors:Krähenbühl, Stephan
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:26 Sep 2016 07:06
Deposited On:06 Feb 2015 09:59

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