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Contents I

MEDICAL RADIOLOGY Diagnostic Imaging

Editors:

A. L. Baert, Leuven K. Sartor, Heidelberg

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Contents III

H. S. Thomsen (Ed.)

Contrast Media

Safety Issues and ESUR Guidelines

With Contributions by

P. Aspelin · M.-F. Bellin · R. W. F. Geenen · J. Å. Jakobsen · G. P. Krestin · S. K. Morcos · R. Oyen J. M. Raine · F. Stacul · H. S. Thomsen · A. J. van der Molen · J. A. W. Webb

Foreword by

A. L. Baert

With 2 Figures and 27 Tables

123

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IV Contents

Henrik S. Thomsen, MD

Professor, Department of Diagnostic Radiology 54E2 Copenhagen University Hospital at Herlev

Herlev Ringvej 75 DK-2730 Herlev Denmark

Medical Radiology · Diagnostic Imaging and Radiation Oncology Series Editors: A. L. Baert · L. W. Brady · H.-P. Heilmann · M. Molls · K. Sartor Continuation of Handbuch der medizinischen Radiologie

Encyclopedia of Medical Radiology

Library of Congress Control Number: 2005925776

ISBN 3-540-20448-2 Springer Berlin Heidelberg New York ISBN 978-3-540-20448-0 Springer Berlin Heidelberg New York

This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifi - cally the rights of translation, reprinting, reuse of illustrations, recitations, broadcasting, reproduction on microfi lm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.

Springer is part of Springer Science+Business Media http//www.springeronline.com

© Springer-Verlag Berlin Heidelberg 2006 Printed in Germany

The use of general descriptive names, trademarks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.

Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every case the user must check such information by consulting the relevant literature.

Medical Editor: Dr. Ute Heilmann, Heidelberg Desk Editor: Ursula N. Davis, Heidelberg Production Editor: Kurt Teichmann, Mauer

Cover-Design and Typesetting: Verlagsservice Teichmann, Mauer Printed on acid-free paper – 21/3151xq – 5 4 3 2 1 0

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Contents V

For more than 10 years the ESUR contrast media safety committee has been providing radiologists with the latest information and updates on the adverse effects and risks of contrast media. The recommendations and guidelines from this committee have gen- erated great interest and are now universally recognized for their high scientifi c value.

They are based on solid scientifi c research, objective data and comprehensive, inde- pendent literature analysis. The long-standing and extensive personal clinical expertise of each of the committee members constitute the base for authoritative statements on many controversial issues regarding the correct use of contrast agents in clinical radi- ology.

As a comprehensive work, this book covers not only the classic iodinated contrast media and barium preparations, but also the more recent MR and US contrast agents.

Indeed, this work brings together an immense volume of data and invaluable specifi c information, originally scattered throughout the literature but now available in one publication.

I most sincerely congratulate H. S. Thomsen and all contributing authors for this outstanding volume, which deserves to become the standard reference in the fi eld.

I am confi dent that it will be of great interest for radiologists and referring physicians in their daily practice.

Leuven Albert L. Baert

Foreword

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Contents VII

Preface

The European Society of Urogenital Radiology established its Contrast Media Safety Committee in 1994. Over the years it has consisted of between 12 and 14 members, the majority of whom are experts in the fi eld of contrast media research. There is currently one member from the scientifi c section of each of the pharmaceutical companies pro- ducing contrast agents (Bracco, Italy; GE Healthcare Diagnostics, USA; Guerbet, France;

Schering, Germany). Although the members of the committee have diverse views the Contrast Media Safety Committee works as one group for the good of patients. The committee benefi ts from the wealth of knowledge on contrast agents brought to it by the representatives of the pharmaceutical companies. However, the rules of the Contrast Media Safety Committee forbid any commercial promotion and the committee deals with all types of contrast agents based purely on objective analysis, sound scientifi c data, well documented clinical experience and clinical common sense. Disagreement within the committee is discussed rationally and without commercial infl uence. All contrast media are referred to by their generic names, except when the generic name is confusing (e.g. ultrasound contrast agents). After 11 years of work the committee has covered all the topics of clinical importance regarding the safe use of contrast media. The current book is mainly a collection of this work together with a few new chapters. The chap- ters have been prepared by the individual authors based on their original papers (see Appendix) when applicable and an up to date review of the literature. Some chapters are new and have never been published as papers by the committee. The chapters have not been circulated among or discussed by the members of the committee and have been edited by myself. In the appendix the latest version of the ESUR guidelines agreed at the meeting of the committee in Copenhagen, February 2005, is presented.

The ESUR guidelines have been well received by the radiological community. They are frequently cited in the literature. They have been incorporated into the protocols of many departments all over the world. They are also used by the health authorities in many countries as a reference for good radiological practice. Several of the guidelines have been translated into languages other than English, for example Spanish, Russian and Japanese.

I am sure the readers will agree that this book offers an invaluable, unique, practical and unparalleled resource dealing with safety issues related to radiographic, MR and ultrasound contrast media, and that it will ultimately benefi t patients.

It has been a great honor for me to serve as chairman of this prestigious commit- tee for 9 years. Special mention goes to the secretary of committee, Dr. Sameh Morcos, whose close cooperation has always been highly productive and inspirational. Without his energy and enthusiasm we would never have accomplished what we have. Also, the past and current members of the committee deserve sincere thanks for their continu-

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VIII Contents

ing involvement and for the outstanding discussions at the annual committee meeting.

Despite disagreements we have always reached a consensus. A special thank you goes to Dr. Judith Webb, who has not only participated actively in our work but has also ensured that our manuscripts were published in correct English. Dr. Webb has revised the English throughout this book and I am most grateful for her outstanding and continuous sup- port. We also thank Professor Albert L. Baert, Editor-in-Chief of European Radiology and Editor-in-Chief of this book series, as well as Springer-Verlag for their immediate endorsement and support of the book.

Finally, I wish to thank my family, especially my wife Pia, for allowing me to invest so many hours of family time in this project.

Herlev, Denmark Henrik S. Thomsen

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Contents IX

1 Classifi cation and Terminology

Peter Aspelin, Marie-France Bellin, Jarl Å. Jakobsen,

and Judith A. W. Webb. . . 1 2 Off-Label Use – Legal Aspects

June M. Raine . . . 5

Section I: General Adverse Reactions . . . 9 3 Prevention of Acute Reactions

Judith A. W. Webb . . . 11 4 Management of Acute Adverse Reactions to Contrast Media

Henrik S. Thomsen. . . 19 5 Late Adverse Reactions to Intravascular Iodinated Contrast Media

Fulvio Stacul. . . 27

Section II: Renal Adverse Eff ects . . . 33 6 Reducing the Risk of Contrast Media Induced Nephrotoxicity

Henrik S. Thomsen. . . 35 7 Dialysis and Contrast Media

Sameh K. Morcos. . . 47 8 Non-Insulin Dependent Diabetes and Contrast Media

Henrik S. Thomsen. . . 53

Section III: Other Adverse Eff ects . . . 57 9 Iodinated and Gadolinium Contrast Media During Pregnancy and Lactation

Judith A. W. Webb . . . 59 10 Effects on Blood and Endothelium

Peter Aspelin, Fulvio Stacul, and Sameh K. Morcos . . . 65 11 Effects on Iodinated Contrast Media on Thyroid Function

Aart J. van der Molen. . . 75

Contents

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X Contents

12 Pulmonary Effects of Radiographic Contrast Media

Sameh K. Morcos. . . 83 13 Phaeocromocytoma

Judith A. W. Webb . . . 89 14 Contrast Media: Interactions with Other Drugs and Clinical Tests

Sameh K. Morcos. . . 93 15 Contrast Medium Extravasation Injury

Jarl Å. Jakobsen. . . 99

Section IV: MR Contrast Media . . . 105 16 Non-tissue Specifi c Extra Cellular MR Contrast Media

Remy W. F. Geenen and Gabriel P. Krestin. . . 107 17 Gadolinium Contrast Media for Radiographic Examinations

Henrik S. Thomsen. . . 113 18 Safety of MR Liver Specifi c Contrast Media

Marie-France Bellin . . . 121

Section V: Ultrasonographic Contrast Media . . . 129 19 Safety of Ultrasound Contrast Agents

Raymond Oyen. . . 131

Section VI: Barium Preparations . . . 137 20 Safety Issues

Sameh K. Morcos. . . 139

Appendix. . . 143 21 ESUR Guidelines on Contrast Media prepared by the Contrast Media

Safety Committee of the European Society of Urogenital Radiology . . . 145

Subject Index . . . 161 List of Contributors. . . 169

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