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Pharmaceutical Drugs

IARC Monographs on the Evaluation of the Carcinogenic Risks to Humans, No. 50

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This volume reports the deliberations of a working group convened to evaluate the carcinogenic risk to humans posed by the therapeutic use of 15 pharmaceutical drugs. The volume features separate monographs on five antineoplastic agents, four antimicrobial agents, two diuretics, ciclosporin (an immunosuppressant), cimetidine (used in the treatment of gastric and duodenal ulcers), paracetamol (a popular analgesic and antipyretic drug), and dantron (a laxative). Drugs were selected for inclusion on the basis of published data suggesting carcinogenic effects in experimental animals or in human patients treated with the drug.

The Working Group identified two of the drugs - ciclosporin and thiotepa - as human carcinogens. Ciclosporin, an immunosuppressant, is widely used in the prevention and treatment of graft-versus-host reactions in bone-marrow transplantation and to prevent the rejection of kidney, heart, and liver transplants. Often given to transplant recipients for several months, ciclosporin has been linked to a remarkably high occurrence of lymphomas, found predominantly in the gastrointestinal tract, as well as to skin cancer and Kaposi's sarcoma. The carcinogenicity of thiotepa, a cytostatic agent used in the treatment of malignant lymphomas and solid tumours, has been clearly demonstrated in both experimental animals and human patients, where treatment with the drug has been linked to the development of leukaemia.

Azacitidine, chloramphenicol, and chlorozotocin were judged to be probably carcinogenic to humans, while dantron and trichlormethine were identified as possible human carcinogens. The remaining substances could not be classified on the basis of currently available evidence. The experts also noted that long-term experiments with paracetamol, nitrofurantoin, and nitrofural have shown reductions in tumour incidence at some sites in some animal species.

Contents

Corrigenda to the IARC Monographs are published online at http://monographs.iarc.fr/ENG/Publications/corrigenda.php.

Corrigenda to Volume 50. (PDF, 35K)

LIBRARY CATALOGUING DATA

IARC MONOGRAPHS

In 1969, the International Agency for Research on Cancer (IARC) initiated a programme on the evaluation of the carcinogenic risk of chemicals to humans involving the production of critically evaluated monographs on individual chemicals. In 1980 and 1986, the programme was expanded to include the evaluation of the carcinogenic risks associated with exposures to complex mixtures and other agents.

The objective of the programme is to elaborate and publish in the form of monographs critical reviews of data on carcinogenicity for agents to which humans are known to be exposed, and on specific exposure situations; to evaluate these data in terms of human risk with the help of international working groups of experts in chemical carcinogenesis and related fields; and to indicate where additional research efforts are needed.

This project is supported by PHS Grant No. 6UO1CA33193-06 awarded by the US National Cancer Institute, Department of Health and Human Services. Additional support has been provided since 1986 by the Commission of the European Communities.

  • ©International Agency for Research on Cancer 1990
  • ISBN 92 832 1250 9
  • ISSN 0250-9555
  • All rights reserved. Application for rights of reproduction or translation, in part or in toto, should be made to the International Agency for Research on Cancer.
  • Distributed for the International Agency for Research on Cancer by the Secretariat of the World Health Organization
  • PRINTED IN THE UK
©International Agency for Research on Cancer, 1990.
Bookshelf ID: NBK526176

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