PDF Drugs During Pregnancy and Lactation - FARMACIJA

[Pages:883]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

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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 Fran?aise de S?curit? Sanitaire de l'Environnement et du Travail, 253 Avenue du G?n?ral Leclerc, 94701 Maisons-Alfort Cedex, France

ELVIRA RODRIGUEZ-PINILLA Servicio de Informacion sobre Teratogenos (SITTE), Secci?n de Teratolog?a Cl?nica, 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 f?r 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-SCH?NDORFER Pharmakovigilanz- und Beratungszentrum f?r 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 wellinformed 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 various sources of information such as the Physicians Desk Reference, package leaflets or general pharmacotherapy handbooks. Formal drug risk classifications or statements such as "contraindicated during pregnancy" may lead to a simplified perception of risk, e.g. an overestimation of the risk or simple fatalism, and withholding of essential therapy or the prescription of insufficiently studied and potentially 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 lactation, 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 indications, the book provides an overview of the relevant drugs in the referring 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.e., 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 breastfeeding 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 expertise in a range of clinical specialties, e.g. dermatology, obstetrics, pediatrics, 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 European Network of Teratology Information Services (ENTIS). The format 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 bestseller ? a strange term ? for a book giving pertinent medical information. 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 editorial 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, occupational 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 precautions 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 accurate; however, they are not responsible for errors or omissions or any consequences from the application of the information in this educational 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 verify 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, relying 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 liability 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

first choice 2 Drug of

second choice S Single dose T Potentially

teratogenic or toxic C Contraindicated

In general, well-tolerated during pregnancy and lactation; nevertheless, always reevaluate requirement for drug treatment Use only if better-tested treatment options fail; there is often insufficient experience during pregnancy and lactation Single and/or low dosages probably tolerable Use only if compellingly indicated. Special prenatal diagnostics are required in case of pregnancy exposure (see referring chapter) No rational indication for use during pregnancy/lactation and/or teratogen or prenatal toxic or toxic during lactation; special prenatal diagnostics are required in case of pregnancy exposure (see referring chapter)

Embryonic period (until week 12 after LMP) Fetal period (from week 13 after LMP) Peripartum Pregnancy, see page Lactation Lactation, see page: Embryonic period (until week 12 after LMP) Fetal period (from week 13 after LMP) Peripartum Pregnancy, see page Lactation Lactation, see page:

Drug

Drug

ACE-inhibitors

T C C 203 2 684 Chloroquine (Malaria 1

Acenocoumarol

T T C 242 2 696 prophylaxis/therapy)

Acetylcysteine

1 1 1 72 1 644 Ciprofloxacin

2

Acetylsalicylic acid (no 2/S T/S T/S 29 2/S 624 Citalopram

1

restriction for low-dose)

Clarithromycine

2

Acitretin

C C C 452 C 766 Clemastine

1

Acyclovir

1 1 1 156 1 670 Clonidine

2

Ambroxol

1 1 1 72 1 644 Clotrimazole

2

Aminoglycosides

T T T 133 2 665 Codeine

1

Amitriptyline, and

1 1 T 289 1 709 Cotrimoxazole

2

other sufficiently

Cromoglycic acid

1

tested tricyclic AD

Cyproterone acetate C

Amphotericin B

2 2 2 140 2 669 Dextran

2

Artemisinin-derivatives 2 1 1 149 2 667 Diazepam

1

AT-II-receptorantagonists

T

C

C 205 T

684 Diclofenac

1

Atropine

1/S 1/S 1/S 102 1/S 652, Digoxin/digitoxin

1

767 Dihydroergotamine 2

Azathioprine

2 2 2 322 2 738 Dimenhydrinate

2

Benzylbenzoate (topical) 1 1 1 458 1 764 Dimetindene

1

-blockers

1/2 1/2 T 196 1/2 680 Diphenhydramine

1

2-Sympathomimetics 1 1 S 64 1 641

(inhalation)

Doxycycline

2

Biperidine

2 2 2 312 2 732 Doxylamine

1

Bromhexine

1 1 1 72 1 644 Ergotamine tartrate T

Bromocriptine

2 T T 386 T/S 748 Erythromycin

2

Butylscopolamine

2 2 2 103 2 652 Estrogens (as

S

Cabergoline Carbamazepine Carbimazol

2 T T 260 T/S 749 contraception

T 2 T 260 T 700 during lactation)

2 2 2 390 2 750 Ethambutol

1

Cephalosporins

1 1 1 125 1 660 Etilefrine

2

Cetirizin

2 2 2 58 1 639 Fentanyl

1

Chloramphenicol

T T T 134 T 664, Fluconazole

2

766 Furosemide

2

1 1 144 1 667

2 2 131 2 663 1 T 291 1 714 2 2 126 1 661 1 1 58 2 640 2 2 207 2 685 1 1 137 1 668 1 T/S 34 1/S 644 2 2 129 2 663 1 1 69 1 643 C C 409 C 757 2 2 249 2 1/S T 257 S 728 T/S T/S 38 S 627 1 1 216 1 686 2 T 215 2 686 1 2 58 1 656 1 1 58 1 640 1 T 83 1/S 640,

656 C C 128 2 662 1 1 83 1 640 T T 42 T 631 1 1 126 1 661 C C 404 2 755

1 1 152 1 666 2 2 216 2 686 1 T 36 2 625 2 2 139 2 668 2 2 225 2 690

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