Off-label use of misoprostol in gynaecology

Turner, J. V., Agatonovic-Kustrn, S. and Ward, H. R. G. (2015) Off-label use of misoprostol in gynaecology. Facts, Views and Vision in ObGyn, 7 4: 261-264.

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Author Turner, J. V.
Agatonovic-Kustrn, S.
Ward, H. R. G.
Title Off-label use of misoprostol in gynaecology
Journal name Facts, Views and Vision in ObGyn   Check publisher's open access policy
ISSN 2032-0418
Publication date 2015-10
Sub-type Letter to editor, brief commentary or brief communication
Open Access Status File (Publisher version)
Volume 7
Issue 4
Start page 261
End page 264
Total pages 4
Place of publication Wetteren, Belgium
Publisher Universa Press
Collection year 2016
Language eng
Abstract Clinical use of drugs is approved for specified clinical indication, route of administration, dose and population group. Off-label prescribing of a registered medicine occurs outside of these parameters and may be justified by pharmacology and physiology, as well as sufficient evidence from published clinical trials and reviews. Misoprostol and mifepristone in combination have recently been registered in Australia for medical termination of pregnancy in women of child-bearing age. There is good clinical evidence for efficacy and safety of misoprostol in uterine evacuation in both miscarriage and termination of pregnancy. The pharmacological effects of misoprostol on the uterus and clinical outcomes in both early miscarriage and abortion are comparable. Medical management of miscarriage with misoprostol in Australia is performed off-label. A woman presenting with first trimester miscarriage must be clearly informed that use of misoprostol in her case is for a non-approved indication. This raises the issue of inequity in her management compared with that of first trimester medical abortion, including being treated off-label and the potential cost of non-subsidised medication. The clinician must also be careful to use an evidence-based protocol that would withstand medicolegal challenge in the case of an adverse outcome
Keyword Miscarriage
Medical termination
Q-Index Code CX
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Letter to editor, brief commentary or brief communication
Collections: Non HERDC
School of Medicine Publications
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Created: Wed, 02 Mar 2016, 16:23:53 EST by Jacky Cribb on behalf of Learning and Research Services (UQ Library)