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14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

15.11. - 16.11.2007, Frankfurt am Main

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Drug-induced haematotoxicity – new safety signals from the Pharmacovigilance Center Berlin (PVZ – FAKOS)

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  • corresponding author E. Bronder - Institut für Klinische Pharmakologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • F. Andersohn - Institut für Klinische Pharmakologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • A. Klimpel - Institut für Klinische Pharmakologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • M. Thomae - Institut für Klinische Pharmakologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • E. Garbe - Institut für Klinische Pharmakologie, Charité Campus Mitte, Universitätsmedizin Berlin

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Frankfurt am Main, 15.-16.11.2007. Düsseldorf: German Medical Science GMS Publishing House; 2007. Doc07gaa19

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/gaa2007/07gaa19.shtml

Published: November 12, 2007

© 2007 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: Serious rare haematotoxicity may significantly alter the risk/benefit ratio of a drug, but it is often only recognized during postmarketing surveillance. Active hospital-based surveillance of serious, rare blood dyscrasias within the Berlin Case-Control Surveillance Study (FAKOS) is a method for new signal generation of drug haematotoxicity.

Objective: To quantify the number of new safety signals of serious drug-induced haematotoxicity generated within the FAKOS Study between October 2000 and Sep 2006.

Material and methods: 467 patients (age ≥18) with first occurrence of a serious rare blood dyscrasia were identified in 54 hospitals and 15 haematological practices in Berlin. WHO causality assessment was performed to identify possible ADRs. For possible ADRs, the German Summary of Product Characteristics (SPC) of the respective drug was screened whether it already contained information on the specific blood dyscrasia (III. Quartal 2006). The information was classified as “no previous information” (= new safety signal), “unspecific information” and “specific information”.

Results: For 38 (20%) out of 194 drugs identified as possible causes of rare blood dyscrasias, there was no previous information available in the German SPC.

Conclusion: FAKOS is an effective instrument for new signal generation during postmarketing surveillance.