Mifepristone is a synthetic anti-progestogenic steroid and glucocorticoid antagonist which sensitises the myometrium to prostaglandin-induced contractions and softens and dilates the cervix. It is used sequentially with a prostaglandin analogue for medical termination of pregnancy, for cervical ripening prior to surgical termination, and for induction of labour following intrauterine fetal death.
Because mifepristone is an effective abortifacient, there are insufficient data to determine if exposure is associated with increased risks of congenital malformation or other adverse pregnancy outcomes. It is important to note that that misoprostol exposure, which often occurs subsequently to mifepristone use, is independently associated with a spectrum of fetal abnormalities, including Möbius syndrome and limb reduction defects.
Enhanced monitoring of fetal viability, growth and development is indicated in ongoing pregnancies exposed to mifepristone. Additional risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.