Drugs in Pregnancy and Lactation PDF
Preview Drugs in Pregnancy and Lactation
A REFERENCE GUIDE TO FETAL AND NEONATAL RISK Drugs in Pregnancy and Lactation, Eleventh Edition 2 A REFERENCE GUIDE TO FETAL AND NEONATAL RISK Drugs in Pregnancy and Lactation, Eleventh Edition Gerald G. Briggs, BPharm, FCCP Pharmacist Clinical Specialist (Obstetrics) (Retired) MemorialCare Center for Women Miller Children’s Hospital Long Beach Memorial Medical Center Long Beach, California Clinical Professor of Pharmacy University of California, San Francisco Adjunct Professor of Pharmacy Practice University of Southern California, Los Angeles Adjunct Professor, Department of Pharmacotherapy Washington State University, Spokane Roger K. Freeman, MD MemorialCare Center for Women Miller Children’s Hospital Long Beach Memorial Medical Center Long Beach, California Director, Mednax Medical Group Clinical Professor of Obstetrics and Gynecology University of California, Irvine Craig V. Towers, MD, FACOG Professor and Vice Chair Department of Obstetrics and Gynecology Division of Maternal-Fetal Medicine University of Tennessee Medical Center, Knoxville Alicia B. Forinash, PharmD, FCCP, BCPS, BCACP Professor of Pharmacy Practice Saint Louis College of Pharmacy Clinical Pharmacy Specialist (Obstetrics) Maternal-Fetal Care Clinic, Saint Mary’s Health Center Saint Louis, Missouri 3 4 Acquisitions Editor: Chris Teja Product Development Editor: Ashley Fischer Editorial Assistant: Brian Convery Marketing Manager: Rachel Mante Leung Production Project Manager: David Saltzberg Design Coordinator: Stephen Druding Manufacturing Coordinator: Beth Welsh Prepress Vendor: SPi Global 11th edition Copyright © 2017 Wolters Kluwer © 2015 Wolters Kluwer Health, © 2011 by LIPPINCOTT WILLIAMS & WILKINS, a Wolters Kluwer business, © 2008, 2005, and 2002 by LIPPINCOTT WILLIAMS & WILKINS. All rights reserved. This book is protected by copyright. No part of this book may be reproduced or transmitted in any form or by any means, including as photocopies or scanned-in or other electronic copies, or utilized by any information storage and retrieval system without written permission from the copyright owner, except for brief quotations embodied in critical articles and reviews. Materials appearing in this book prepared by individuals as part of their official duties as U.S. government employees are not covered by the above-mentioned copyright. To request permission, please contact Wolters Kluwer at Two Commerce Square, 2001 Market Street, Philadelphia, PA 19103, via email at [email protected], or via our website at lww.com (products and services). 9 8 7 6 5 4 3 2 1 Printed in China Cataloging-in-Publication Data available on request from the Publisher. ISBN: 978-1-4963-4962-0 This work is provided “as is,” and the publisher disclaims any and all warranties, express or implied, including any warranties as to accuracy, comprehensiveness, or currency of the content of this work. This work is no substitute for individual patient assessment based upon healthcare professionals’ examination of each patient and consideration of, among other things, age, weight, gender, current or prior medical conditions, medication history, laboratory data and other factors unique to the patient. The publisher does not provide medical advice or guidance and this work is merely a reference tool. Healthcare professionals, and not the publisher, are solely responsible for the use of this work including all medical judgments and for any resulting diagnosis and treatments. Given continuous, rapid advances in medical science and health information, independent professional verification of medical diagnoses, indications, appropriate pharmaceutical selections and dosages, and treatment options should be made and healthcare professionals should consult a variety of sources. When prescribing medication, healthcare professionals are advised to consult the product information sheet (the manufacturer’s package insert) accompanying each drug to verify, among other things, conditions of use, warnings and side effects and identify any changes in dosage schedule or contraindications, particularly if the medication to be administered is new, infrequently used or has a narrow therapeutic range. To the maximum extent permitted under applicable law, no responsibility is assumed by the publisher for any injury and/or damage to persons or property, as a matter of products liability, negligence law or otherwise, or from any reference to or use by any person of this work. LWW.com 5 Foreword This book is now in its 11th edition and continues to enjoy great success with physicians and other professionals involved in the care of pregnant and lactating patients. Many of the reviews are exhaustive but pertinent to the management of pregnant and lactating patients who have already ingested a drug or who are in need of drug therapy where a cost–benefit analysis may be necessary for appropriate counseling. There are seldom absolute answers to questions a woman may have when she ingests a drug when pregnant or nursing because human experience is usually, of necessity, somewhat anecdotal. Even with all the information in this publication, there are risks that are yet unknown that may apply to a small number of people making the dictum of not using drugs in pregnancy without good cause still important. The effect of drugs in animals, the importance of timing and dose, and the effect of environmental factors are all involved in the risks and benefits of drugs in pregnant and/or lactating women and their fetuses/neonates. These factors are considered when data are available, but we must admit that in no individual case is the understanding of risks and benefits absolute. Because many pregnant and lactating women take substances, both legal and illegal, without the knowledge of their caregivers, the challenge to understand the risks/benefits of any drug and its interactions with these substances is daunting. Today, we are just beginning to understand the specific genetic influences on the action, toxicity, and teratogenicity of drugs in an individual. I expect in the future there will be many identified genetic factors that will influence therapeutic decisions. While we will again miss the great contributions of Dr. Sumner Yaffe, the addition of Dr. Craig Towers and Dr. Alicia Forinash will be very important going forward. It is our hope that the 11th edition will continue to provide the practitioner appropriate assistance with questions regarding drugs in pregnancy and lactation. Roger K. Freeman, MD University of California, Irvine I have been using this book since the 1st edition in 1983. As a new coauthor, I now have the opportunity to participate in its production. This reference book continues to be one of the primary sources for determining the risks of a particular medication that is or might be used during pregnancy, as well as during breastfeeding. The 11th edition adds 142 new drugs to the large volume that currently exist, and many of the drugs in this edition have been updated with new information. In the management and care of a woman who becomes pregnant while on medications and/or requires drug treatment during pregnancy, the information supplied in this text provides clinicians with vital data to council their patients. However, a continuing concern is the absence or very limited human pregnancy data for most of the drugs. Nevertheless, I have no doubt that this edition will continue to aid practitioners worldwide on this subject. Craig V. Towers, MD, FACOG 6 University of Tennessee Medical Center, Knoxville In my years as a clinical pharmacist specialist in obstetrics, this book has always been my go to reference. The summary and in-depth reviews provide valuable information to assist with decisions about medication safety in pregnancy and lactation. When evaluating drug use during pregnancy, there are several critical things to consider. Here are two of them. It is important to evaluate both the gestational age and the time when the various tissues are forming. For example, a drug that increases the risk of oral clefts could be used after the 1st trimester because the oral tissue would already be formed. It is also important to consider the risks of the medications and compare these to the embryo–fetal risks of untreated maternal disease. Many maternal diseases have higher risks for the mother than the embryo–fetal risk from drugs used to treat the disease. I also want to thank my husband, Brian, and my children, Riley and Cole, for all of their support while I have been working on this edition. Alicia B. Forinash, PharmD, FCCP, BCPS, BCACP Saint Louis, Missouri 7 Preface We are very fortunate to have two respected clinicians join us as coauthors in the preparation of the 11th edition. Dr. Towers is a maternal–fetal medicine specialist in Tennessee, and Dr. Alicia Forinash is a clinical pharmacist specialist in obstetrics in St. Louis. Both have published extensively and are knowledgeable in the effects of drugs on the embryo–fetus and nursing infant. As with the previous edition, this edition is available in print and online. We have attempted to reduce the size of the book by removing 33 reviews of drugs that are no longer marketed. If information is needed for those agents, it can be obtained by referring to the 10th edition. This edition contains 142 new drug reviews, only two of which have human pregnancy data. None have reported use during breastfeeding. We also have revised a large number of reviews. Nevertheless, published human data continue to be very limited for most of the drugs in this book. This places the clinician in a difficult position. How do they council the patient, who is pregnant or may become pregnant during treatment, when they are prescribing a medication with no or limited human data and there are no other drugs with the same mechanism of action that have human pregnancy data? In this situation, the clinician must decide if treatment of the patient’s condition provides a benefit to her that exceeds the potential risk to the embryo and/or fetus. The four questions that we ask ourselves when estimating that risk are described below. First, is there human pregnancy experience for the drug? In most cases, the answer to this question is no. Second, is there developmental toxicity in humans with other drugs in the same pharmacologic class? With a few exceptions (e.g., ACE inhibitors ARII-blockers, β-blockers, nonsteroidal ant-inflammatory drugs), the answer is not known because many new drugs have highly specific mechanisms and are in a class by themselves. Third, does the drug cross the placenta? Drugs with molecular weights less than 600 usually cross easily, but factors such as the elimination half-life, lipid solubility, and plasma protein binding can significantly modify the amount crossing. However, in the second half of pregnancy, most drugs, even those with high molecular weight, will cross regardless of these modifying factors. Fourth, does the drug cause developmental toxicity in animals and can these data be used to estimate human risk? We attempted to answer this question in a recent article (Briggs GG, et al. Should pregnant women be included in phase IV clinical drug trials? Am J Obstet Gynecol 2015; 810–5). Animal data for 311 drugs in the 10th edition raised the possibility of human harm that has been confirmed in 75 drugs (24%). Thus, the animal data do not provide an adequate assessment, but it can be used in combination with the answers to the other questions and an assessment of the disease risk to the mother when counseling the patient. This appears to be better than saying “We just don’t know” when a patient asks if this drug will hurt her developing baby. As in previous editions, some drug reviews have toll-free telephone numbers for the use of health care professionals or patients to enroll in observational studies. These studies are an important method for gathering prospective data on pregnancy exposures for high-risk drugs. In fact, such studies are often the only 8 human pregnancy experience available for new drugs and pharmacologic drug classes. The data generated by these studies and registries can be valuable for the raising of hypotheses of major teratogenicity or providing some assurance that the agent is not a significant teratogen. Because their importance is so high, health care professionals and patients are encouraged to call for information about patient enrollment. Gerald G. Briggs, BPharm, FCCP Pharmacist Clinical Specialist (Obstetrics) (Retired) MemorialCare Center for Women Miller Children’s Hospital Long Beach Memorial Medical Center Long Beach, California Clinical Professor of Pharmacy University of California, San Francisco Adjunct Professor of Pharmacy Practice University of Southern California, Los Angeles Adjunct Professor, Department of Pharmacotherapy Washington State University, Spokane 9 Contents Foreword Preface Instructions for Use of the Reference Guide Monographs Appendix Index 10
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