gms | German Medical Science

15. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

20.11. - 21.11.2008, Bonn

Identification of drugs causing Blood Dyscrasias, Hepatitis and Pancreatitis – Outcomes of the Case-Control Surveillance Study from the National Pharmacovigilance-Center Berlin (PVZ-FAKOS)

Identifikation von Arzneimittel-induzierten Blutdyskrasien, Hepatididen und Pankreatitiden. Zwischenergebnisse vom Berliner Pharmakovigilanz-Zentrum (PVZ-FAKOS)

Meeting Abstract

  • corresponding author Michael Thomae - Institute of Clinical Pharmacology und Toxicology, Charité-Universitaetsmedizin Berlin
  • Elisabeth Bronder - Institute of Clinical Pharmacology und Toxicology, Charité-Universitaetsmedizin Berlin
  • Frank Andersohn - Institute of Clinical Pharmacology und Toxicology, Charité-Universitaetsmedizin Berlin
  • Andreas Klimpel - Institute of Clinical Pharmacology und Toxicology, Charité-Universitaetsmedizin Berlin
  • Edeltraut Garbe - Institute of Clinical Pharmacology und Toxicology, Charité-Universitaetsmedizin Berlin

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 15. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn, 20.-21.11.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. Doc08gaa10

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/gaa2008/08gaa10.shtml

Veröffentlicht: 6. November 2008

© 2008 Thomae 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 vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

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Background and aim: Rare adverse drug reactions (ADR) are frequently associated with severe clinical manifestations. The German National Pharmacovigilance Center based in Berlin (PVZ-FAKOS) uses an active surveillance approach to identify hospitalised patients with specific serious rare diseases (cases) and control patients. Hereby drugs can be identified which are manifesting the target diseases as an ADR. Objectives: To investigate which drugs are a probably cause of blood dyscrasias, hepatitis and pancreatitis based on the data in PVZ-FAKOS.

Material and method: 580 patients (age > 18) with a validated diagnosis of blood dyscrasias (Oct. 2000 – Dec. 2007), 97 patients with acute hepatitis and 58 patients with acute pancreatitis (Oct. 2002 – Dec. 2007) from hospitals in Berlin, Germany, were included. Drug causality was assessed by applying the WHO causality assessment method. Only cases in which causality was assessed as “certain” or “probable” were included in this analysis (blood dyscrasias N=77; hepatitis N=19; pancreatitis N=7).

Results: A total of 56 different drugs were identified as causes of blood dyscrasias (agranulocytosis, N=29; immune thrombocytopenia, N=20; immune hemolytic anemia, N=7; aplastic anemia, N=3; TTP/HUS, N=2). For drug-induced hepatitis and pancreatitis, 23 and 5 different drugs were identified, respectively. Drugs involved in >2 cases of blood dyscrasias were tirofiban (N=8), clozapine (N=5), diclofenac (N=7), dipyrone (N=5), methimazole (N=5), carbamazepine (N=3), ceftriaxon (N=3), and sulfasalazine (N=4). Drugs involved in >2 cases of hepatitis and pancreatitis were phenprocoumon (N=4) and azathioprine (N=3), respectively.

Conclusion: The disease based approach of the German National Pharmacovigilance Center PVZ FAKOS enables identification of drugs causing rare ADRs taking advantage of a standardized causality assessment. The approach is independent of the suspicion of an ADR by the treating physician. Thus, data generated for a case-control approach can also be used successfully for signal generation.

Acknowledgement: PVZ-FAKOS is being funded by the Federal Institute for Drugs and Medical Devices (BfArM, Germany).