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PrescribingmedicinesinpregnancyAn Australiancategorisation ofrisk of drug use inpregnancyAustralian Drug Evaluation CommitteeThe Australian categorisation consists of the following categories:Category ADrugs which have been taken by a large number of pregnant women and women ofchildbearing age without any proven increase in the frequency of malformations or otherdirect or indirect harmful effects on the fetus having been observed.Category CDrugs which, owing to their pharmacological effects, have caused or may be suspectedof causing, harmful effects on the human fetus or neonate without causing malformations.These effects may be reversible. Accompanying texts should be consulted for furtherdetails.Category B1Drugs which have been taken by only a limited number of pregnant women and womenof childbearing age, without an increase in the frequency of malformation or other director indirect harmful effects on the human fetus having been observed.Studies in animals have not shown evidence of an increased occurrence of fetal damage.Category B2Drugs which have been taken by only a limited number of pregnant women and womenof childbearing age, without an increase in the frequency of malformation or other director indirect harmful effects on the human fetus having been observed.Studies in animals are inadequate or may be lacking, but available data show no evidenceof an increased occurrence of fetal damage.Category B3Drugs which have been taken by only a limited number of pregnant women and womenof childbearing age, without an increase in the frequency of malformation or other director indirect harmful effects on the human fetus having been observed.Studies in animals have shown evidence of an increased occurrence of fetal damage,the significance of which is considered uncertain in humans.Category DDrugs which have caused, are suspected to have caused or may be expected to cause,an increased incidence of human fetal malformations or irreversible damage. Thesedrugs may also have adverse pharmacological effects. Accompanying texts should beconsulted for further details.Category XDrugs which have such a high risk of causing permanent damage to the fetus that theyshould not be used in pregnancy or when there is a possibility of pregnancy.Prescribing medicinesin pregnancyAn Australian categorisation of riskof drug use in pregnancy© Commonwealth of Australia 1999ISBN 0 642 41553 6This work is copyright. Apart from any use as permitted under theCopyright Act 1968, no part may be reproduced by any process withoutprior written permission from the Commonwealth available fromAusInfo. Requests and inquiries concerning reproduction and rightsshould be addressed to the Manager, Legislative Services, AusInfo, GPOBox 1920, Canberra ACT 2601.First published 1989Second edition 1992Reprinted 1994Third edition 1996Fourth edition 1999
Prepared by the Medicines in Pregnancy Working Party of the Australian Drug
Evaluation Committee (printing partially funded by the Pharmaceutical Education
Program).
Enquiries should be directed to
Publications Unit
TGA
PO Box 100
Woden ACT 2606
Publications approval number 2637
From the Chairman
It is now ten years and four editions since Medicines in Pregnancy was
first produced by the Australian Drug Evaluation Committee to assist
health professionals in the appropriate prescription of drugs in pregnancy.
Over one hundred new medicines have been evaluated and approved for
registration in Australia since the publication of the last edition in 1996
and have been added to the current booklet. In addition, the introduction
of colour printing has allowed a revision of the layout of the text to
improve the clarity of information provided.
This edition has been retitled Prescribing Medicines in Pregnancy, to
emphasise the purpose of the booklet — guiding the prescriber in the
correct choice of medication when drug therapy is required in pregnancy.
This booklet is not intended for use in the more complex situation of
inadvertent drug exposure in early pregnancy, and for this circumstance,
the reader is referred to the Obstetric Drug Information Services listed
in Appendix B.
The Australian Drug Evaluation Committee is keen to ensure that
appropriate therapeutic options are available to all women needing
medical treatment or preventative therapy during pregnancy, with
minimisation of any associated risk to the fetus. An essential prerequisite,
and the aim of this booklet, is the provision of accurate, concise
information as a basis for informed consent and rational decision making.
As always, the Committee welcomes feedback and is most grateful to
those who have offered constructive suggestions about past editions.
Dr Rosemary Ayton
Chairman
Medicines in Pregnancy Working Party
v
CO NTENTS
INTRODUCTION x
AUSTRALIAN CATEGORISATION OF DRUGS
ALIMENTARY SYSTEM
Hyperacidity, reflux, ulcers 2
Antispasmodics 2
Laxatives 2
Antidiarrhoeals 2
Cholelitholytics 3
CA
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