Facts, Views & Vision
in ObGyn

Journal of the European Society for Gynaecological Endoscopy

esge_logo

Off-label use of misoprostol in gynecology

J.V. Turner1,2, S. Agatonovic-Kustrn3, H.R.G. Ward2,4

1University of Queensland, School of Medicine – Rural Clinical School, Toowoomba, Australia.

2University of New South Wales, School of Medicine – Rural Clinical School, Coffs Harbour, Australia.

3Universiti Teknologi MARA, Faculty of Pharmacy, Bandar Puncak Alam, Malaysia.

4Centre for Women’s Reproductive Care, Coffs Harbour, Australia.

Correspondence at: Joseph Vernon Turner, 152 West St, 4350 Toowoomba, Australia. jturner3@uq.edu.au

Keywords:

Miscarriage, medical termination of pregnancy, MTOP, abortion, mifepristone, equity


Published online: Jan 11 2016

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.