Drugs During Pregnancy and Lactation Treatment options and risk assessment Second edition Edited by Christof Schaefer, Paul Peters, and Richard K. Miller AMSTERDAM • BOSTON • HEIDELBERG • LONDON • NEW YORK • OXFORD PARIS • SAN DIEGO • SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier 84 Theobald’s Road, London WC1X 8RR, UK 30 Corporate Drive, Suite 400, Burlington, MA 01803, USA 525 B Street, Suite 1900, San Diego, California 92101-4495, USA First edition 2001 Second edition 2007 Copyright © 2001, 2007 Elsevier BV. All rights reserved No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher Permissions may be sought directly from Elsevier’s Science & Technology Rights Department in Oxford, UK: phone (+44) (0) 1865 843830; fax (+44) (0) 1865 853333; email: permissions@elsevier. Alternatively you can submit your request online by visiting the Elsevier web site at http://elsevier.com/locate/permissions, and selecting Obtaining permission to use Elsevier material Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein.
Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Catalog in Publication Data A catalog record for this title is available from the Library of Congress ISBN: 978-0-444-52072-2 For information on all Academic Press publications visit our web site at http://books.com Typeset by Charon Tec Ltd (A Macmillan Company), Chennai, India www.com Printed and bound in Great Britain 07 08 09 10 11 10 9 8 7 6 5 4 3 2 1 List of contributors MATITIAHU BERKOVITCH Drug Information Center, Assaf Harofeh Medical Center, 70300 Zerifin, Israel HANNEKE GARBIS Teratology Information Service, National Institute of Public Health and Environment, PO Box 1, 3720 BA Bilthoven, The Netherlands LEE H. GOLDSTEIN Internal Medicine Department C, Haemek Medical Center, Afula 18101, Israel HENRY M. HESS Department of Obstetrics and Gynecology, University of Rochester, School of Medicine and Dentistry, 2255 Clinton Avenue, Rochester, NY, 14618, USA RUTH LAWRENCE Lactation Research Center, Department of Pediatrics, University of Rochester, School of Medicine and Dentistry, 601 Elmwood Avenue, Rochester, NY, 14642-8777, USA PATRICIA McELHATTON The National Teratology Information Service (NTIS), Regional Drug & Therapeutics Centre, Claremont Place, Newcastle-upon-Tyne, NE2 4HH, UK RICHARD K. MILLER PEDECS, NY Teratogen Information Service, Department of Obstetrics and Gynecology, University of Rochester, School of Medicine and Dentistry, 601 Elmwood Avenue, Rochester, NY, 14642-8668, USA ASHER ORNOY Israel Teratogen Information Service, Jerusalem Child Developmental Center, Rechov Yafo 157, Jerusalem, Israel PAUL PETERS University Medical Centre Utrecht, Department of Obstetrics, Karel Doormanlaan 150, 3572 NR Utrecht, The Netherlands List of contributors xxiii MINKE REUVERS Teratology Information Service, National Institute of Public Health and Environment, PO Box 1, 3720 BA Bilthoven, The Netherlands ELISABETH ROBERT-GNANSIA Agence Française de Sécurité Sanitaire de l’Environnement et du Travail, 253 Avenue du Général Leclerc, 94701 Maisons-Alfort Cedex, France ELVIRA RODRIGUEZ-PINILLA Servicio de Informacion sobre Teratogenos (SITTE), Sección de Teratología Clínica, Centro de Investigacion sobre, Anomalias Congenitas (CIAC), Instituto de Salud Carlos III, c/ Sinesio Delgado 6 (Pabellon 6), 28029 Madrid, Spain MARGREET ROST VAN TONNINGEN Teratology Information Service, National Institute of Public Health and Environment, PO Box 1, 3720 BA Bilthoven, The Netherlands CHRISTOF SCHAEFER Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany HERMAN VAN GEIJN Department of Obstetrics and Gynaecology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands CORINNA WEBER-SCHÖNDORFER Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany Preface Physicians and all health care providers who care for women in their reproductive years are frequently asked by concerned women who are planning a pregnancy, are pregnant or breastfeeding about the risk of medicinal products for themselves, their unborn or breastfed infant.
These Dermatologists, Family Medicine physicians, Internists, Obstetricians, Pediatricians, Pharmacists, Midwives, Nurses, Lactation consultants, Medical geneticists, Psychiatrists, Psychologists, Toxicologists to name but a few should be well- informed in regard to acceptable treatment options and be capable of assessing the risk of an inadvertent or required treatment/exposure. All aspects of drug counseling are inadequately supported by var- ious sources of information such as the Physicians Desk Reference, package leaflets or general pharmacotherapy handbooks. Formal drug risk classifications or statements such as “contraindicated dur- ing pregnancy” may lead to a simplified perception of risk, e. an overestimation of the risk or simple fatalism, and withholding of essen- tial therapy or the prescription of insufficiently studied and poten- tially risky drugs may result.
This simplified perception of risk, can lead to unnecessary invasive prenatal diagnostic testing or even to a recommendation to terminate a wanted pregnancy. During lacta- tion, misclassification of drug risk may lead to the advice to stop breastfeeding, even though the drug in question is acceptable or alternatives appropriate for the breastfeeding period are available. This book is based on a survey of the literature on drug risks during pregnancy and lactation, as yet unpublished results of recent studies, and current discussions in professional societies dealing with clinical teratology and developmental toxicology. The book reflects accepted “good therapeutic practice” in different clinical areas.
It is written for clinical decision-makers. Arranged according to treatment indica- tions, the book provides an overview of the relevant drugs in the refer- ring medical area available on the market today that might be taken by women of reproductive age. The book’s organization facilitates a comparative risk approach, i., identifying the drugs of choice for particular diseases or symptoms. In addition, recreational drugs, diagnostic procedures (X-ray), vaccinations, poisoning, workplace and environmental contaminants, herbs, supplements and breastfeed- ing during infectious diseases are discussed in detail.
The second edition has had major revisions throughout, most sections were completely rewritten. The content has been adapted for an international readership. Two additional editors were enlisted; Preface xxv the number of contributing authors has increased and reflects expert- ise in a range of clinical specialties, e. dermatology, obstetrics, pedi- atrics, internal medicine, psychiatry and many others.
Moreover, most authors are active members of the teratology societies including the Organization of Teratogen Information Specialists (OTIS) and Euro- pean Network of Teratology Information Services (ENTIS). The for- mat is completely different and last but not least the price is much lower – making the book available to far greater readership. It is important to realize that the origin of this book lies in a book published in German last year in its 7th edition. The success of the latter (more than 50 000 copies sold) can be described as a best- seller – a strange term – for a book giving pertinent medical infor- mation.
This also demonstrates the need to be informed in this difficult area of pharmacotherapeutics during pregnancy. We are grateful to Kirsten Funk, publishing editor, from Elsevier/ Academic Press for providing support and advice for this project to thrive. We thank Sue Armitage for copy editing and Claire Hutchins from Elsevier for overseeing production. The editors truly appreciate the many hours of work each contributor has performed in the development of their chapters and with the suggested edito- rial revisions.
Finally, the editors wish to express our appreciation to our families for providing the time and support to develop this volume. May the reader use this volume to examine treatment options for specific diseases not only during pre-pregnancy but also before the woman becomes pregnant. By providing prepregnancy counseling, the editors and authors hope that inappropriate therapeutic, occu- pational and/or environmental exposures will be minimized. Richard K Miller, Rochester, New York, USA Christof Schaefer, Berlin, Germany Paul Peters, Utrecht, Netherlands May 2007 Notice Medical knowledge is constantly changing.
Standard safety precau- tions must be followed, but as new research and clinical experience broaden our knowledge, changes in treatment and drug therapy may become necessary or appropriate. The Authors and Editors have expended substantial effort to ensure that the information is accu- rate; however, they are not responsible for errors or omissions or any consequences from the application of the information in this educa- tional publication and make no warranty, expressed or implied, with respect to the currency, completeness or accuracy of this publication. Readers are advised to check the most current product information provided by the manufacturer of each drug to be administered to ver- ify the recommended dose, the method and duration, adverse drug effects, and interactions. Application of the content of this volume for a particular situation remains the professional responsibility of the practitioner.
It is ultimately the responsibility of the practitioner, rely- ing on experience and knowledge of the patient, to determine dosages and the best treatment or intervention for each individual patient. Neither the Publisher, the Editors nor the Authors assume any liabil- ity for any injury and/or damage to persons or property arising from this publication. Table 1 Risk and safety of medicinal drugs Caution: ■ Use table for general orientation only; review details in the referring chapter. Never use the table to decide upon termi- nation of a pregnancy.
■ Withdrawal from breastfeeding is rarely necessary because of maternal drug treatment. For almost all diseases there are drugs compatible with breastfeeding; review details in the referring chapter. ■ If not indicated otherwise, risk classifications refer to systemic drug use. Exception: drugs only available for topical application.
Risk classification: 1 Drug of In general, well-tolerated during pregnancy and lactation; nevertheless, always reevaluate first choice requirement for drug treatment 2 Drug of Use only if better-tested treatment options fail; there is often insufficient experience during second choice pregnancy and lactation S Single dose Single and/or low dosages probably tolerable T Potentially Use only if compellingly indicated.