Off-label use of misoprostol in gynaecology

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.