1. Description:
(1) Mifepristone (or RU-486) is a synthetic steroid compound with both antiprogesterone and antiglucocorticoid properties. The compound is a 19-nor steroid with substitutions at positions C11 and C17 (17 beta-hydroxy-11 beta-[4-dimethylamino phenyl] 17 alpha-[1-propynyl]estra-4,9-dien-3-one), which antagonizes cortisol action competitively at the receptor level.
(2) Mifepristone is a progesterone receptor antagonist used as an abortifacient in the first months of pregnancy, and in smaller doses as an emergency contraceptive. It is also a powerful glucocorticoid receptor antagonist, and has occasionally been used in refractory Cushing's syndrome (due to ectopic/neoplastic ACTH/cortisol secretion). During early trials, it was known as RU-38486 or simply RU-486, its designation at the Roussel Uclaf company, which designed the drug. The drug was initially made available in France, and other countries then followed—often amid controversy. It is marketed under tradenames Korlym and Mifeprex, according to FDA Orange Book.
Mifepristone was the first antiprogestin to be developed and it has been evaluated extensively for its use as an abortifacient. The original target for the research group, however, was the discovery and development of compounds with antiglucocorticoid properties. These antiglucocorticoid properties are of great interest in the treatment of severe mood disorders and psychosis, although a review of published articles was inconclusive on their efficacy, and considered the use of these drugs in mood disorders at 'proof of concept' stage. It is on the World Health Organization's List of Essential Medicines.
2. Usage:
(1) All methods of first-trimester abortion carry a small risk of failure to terminate the pregnancy. The risk for surgical abortion is around 0.23% and for medical abortion is between 0.1% and 1.4% (depending on the regimen used and the experience of the centre).
(2) Medical abortion using mifepristone plus prostaglandin is the most effective method of abortion at gestations of less than 7 weeks.
(3) Conventional vacuum aspirations below 7 weeks have a higher failure rate than at later gestations. Protocols should include examination of the aspirate for the presence of the gestational sac and/or follow-up serum human chorionic gonadotrophin estimation, to ensure abortion completion.
(4) Early vacuum aspiration using a rigorous protocol (which includes magnification of aspirated material and indications for serumβhCG follow-up) may be used at gestations below 7 weeks, although data suggest the failure rate is higher than for medical abortion.
Medical abortion using mifepristone plus prostaglandin continues to be an appropriate method for women in the 7–9 week gestation band.
3. Adverse effects:
(1) No long-term studies to evaluate the carcinogenic potential of mifepristone have been performed. This is in accord with ICH guidelines, which do not require carcinogencity testing in nongenotoxic drugs intended for administration for fewer than 6 months.
(2) Neonatal exposure to a single large dose of mifepristone in rats was not associated with any reproductive problems, although chronic low-dose exposure of newborn rats to mifepristone was associated with structural and functional reproductive abnormalities.
(3) Teratology studies in mice, rats, and rabbits revealed teratogenicity for rabbits, but not rats or mice. The rate of birth defects in human infants exposed in utero to mifepristone and misoprostol is very low, and may be due to misoprostol alone.
(4) A postmarketing summary found, of about 1.52 million women who had received mifepristone until April 2011 in the United States, 14 were reported to have died after application. Eight of these cases were associated with sepsis; the other six had various causes such as drug abuse and suspected murder. Other incidents reported to the FDA included 612 nonlethal hospitalizations, 339 blood transfusions, 48 severe infections, and 2,207 (0.15%) adverse events altogether.
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