gms | German Medical Science

16th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

19.11. - 20.11.2009, Berlin

Metamizole (Dipyrone) Induced Acute Agranulocytosis – How rare is it really? Preliminary results from the National Pharmacovigilance-Center Berlin (PVZ-FAKOS)

Meeting Abstract

  • corresponding author E. Bronder - Charité-Universitymedicine Berlin, Berlin, Germany
  • A. Klimpel - Charité-Universitymedicine Berlin, Berlin, Germany
  • F. Andersohn - Charité-Universitymedicine Berlin, Berlin, Germany
  • E. Garbe - Charité-Universitymedicine Berlin, Berlin, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 16. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Berlin, 19.-20.11.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gaa06

DOI: 10.3205/09gaa06, URN: urn:nbn:de:0183-09gaa060

Published: November 5, 2009

© 2009 Bronder et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Background and aim: Despite the well-known risk of acute agranulocytosis, ambulatory prescriptions of metamizole raised from 32.2 Mio. Defined Daily Doses (DDD) in 2000 to 85.8 Mio. DDD in 2007 (+166%). The total number of German adult patients with metamizole induced agranulocytosis leading to hospitalisation or occurring in the hospital has not been estimated so far.

Material and method: Within PVZ-FAKOS, a German National Pharmacovigilance Center in Berlin, hospitalised patients with acute agranulocytosis in Berlin were identified. WHO causality assessment was used to identify cases caused by metamizole. We estimated the total number of patients with metamizole induced agranulocytosis in Germany under the assumption of 100% case ascertainment and similar metamizole prescription habits as in whole Germany.

Results: 92 patients with a validated diagnosis of AGR were included from Oct 2000 to June 2009 with 27 of them (29.3%) attributed to metamizole. The total numbers of adults with metamizole induced agranulocytosis in Germany were estimated as approx. N=633 during the total study period (95% confidence interval [CI] 417–921) or N=72 per year (95% CI 48–105).

Conclusions: Even with the conservative assumption of complete case ascertainment in Berlin, a substantial number of patients were affected by metamizole induced agranulocytosis during the last years in Germany. Given the potential fatal consequences of agranulocytosis, these estimates support concerns about the increasing ambulatory use of metamizole in Germany.

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