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Mifepristone is a imitation steroid compound used as a pharmaceutical. It is used as an abortifacient in the first two months of pregnancy, and in smaller doses as an exigency contraceptive. During early trials, it was known as RU-486 , its designation at the Roussel Uclaf suite, which designed the drug. The drug was initially made available in France, and other countries then followed—on numerous occasions amid controversy. In France and countries other than the United States it is marketed and distributed by Exelgyn Laboratories protection the tradename Mifegyne . In the United States it is sold by Danco Laboratories under the tradename Mifeprex .

Biography

The compound was discovered by researchers at Roussel Uclaf of France in 1980 (the "RU" in RU-486) while they were studying glucocorticoid receptor antagonists. Étienne-Émile Baulieu recognized its anti-progesterone activities and saw its developing for the induction of a medical abortion. Clinical testing began in 1982. The drug was elementary licensed in France in 1988, for use in combination with a prostaglandin, under the name Mifegyne. After accredit approval but before market release, Roussel Uclaf announced it would depart from distribution of the drug, bowing to pressure from pro-life groups and the threat of a shun. However, two days later, the French government, part owner of Roussel Uclaf, intervened, outstanding to the resumption of production and distribution of RU-486. The French Health Minister, explaining the authority's intervention, stated, "I could not permit the abortion debate to deprive women of a effect that represents medical progress. From the moment Government approval for the narcotize was granted, RU-486 became the moral property of women."

Indications

Mifegyne is sold facing the U.S. by Exelgyn Laboratories, made in France, and is approved for:

1. Medical termination of intrauterine pregnancies of up to 49 days gestation (up to 63 days gestation in Britain and Sweden)
2. Softening and dilatation of the cervix earlier to mechanical cervical dilatation for pregnancy termination
3. Use in combination with gemeprost for desinence of pregnancies between 13 and 24 weeks gestation
4. Labor induction in fetal extirpation in utero.

Mifeprex is sold in the U.S. by Danco Laboratories, made in China, and is U.S. Food and Antidepressant Administration-approved to terminate intrauterine pregnancies of up to 49 days gestation. Underneath the FDA-approved regimen, a 600 mg dose is administered by a clinician following a counseling term. Two days later, a clinician administers 400 µg of another medicine, misoprostol, to inspire contractions. In European studies, this method terminated 96 to 99% of pregnancies of up to 49 days gestation, but in one mammoth multicenter trial in the U.S. conducted from September 1994 to September 1995, the efficacy was shame (92%), which the authors of the study suggested may have been due to lack of endure with this method in the U.S. and/or the design of their study. In Europe and China, an announcement period of several hours is required after administration of misoprostol. If expulsion of fetal fabric does not occur during the observation period, surgical abortion is offered. There is no required inspection period in the U.S., but it is strongly recommended.

According to the current RCOG abortion evidence-based clinical guideline:

• All methods of outset-trimester abortion carry a small risk of failure to terminate the pregnancy, fashion necessitating a further procedure. The risk for surgical abortion is around 0.23% and for medical abortion between 0.1% and 1.4% (depending on the regimen cast-off and the experience of the centre).
• Medical abortion using mifepristone plus prostaglandin is the most personal property method of abortion at gestations of less than 7 weeks.
• Conventional vacuum hope should be avoided at gestations below 7 weeks.
• Early vacuum aspiration using a rigorous rules (which includes magnification of aspirated material and indications for serum βhCG follow-up) may be acquainted with at gestations below 7 weeks, although data suggest that the failure tariff is higher than for medical abortion.
• Medical abortion using mifepristone benefit prostaglandin continues to be an appropriate method for women in the 7–9 week gestation body.

Mifepristone can also be used in smaller doses as an emergency contraceptive; if taken after sex but up front ovulation, it can prevent ovulation and so prevent pregnancy. In this role, a 10 mg measure is not as effective as the 600 mg dose, but has fewer side-effects. Mifeprex and Mifegyne are only available in 200 mg tablets. A review of studies in humans found that the contraceptive effects of the 10 mg dose were to all intents due mainly to its effects on ovulation, and not inhibition of implantation, but "the knowledge of the mechanism of action remains unfinished." Treatment with 200 mg of mifepristone changes steroid receptor expression in the fallopian tube, inhibits endometrial increase, and effectively prevents implantation.

Other uses

Other medical applications of mifepristone that be dressed been studied in Phase II clinical trials include regular long-stint use as an oral contraceptive, and treatment of: uterine fibroids, endometriosis, major impression with psychotic features, glaucoma, meningiomas, breast cancer, ovarian cancer, prostate cancer, and some types of Cushing's syndrome.

Mifepristone has been calculated as an antiretroviral for its in vivo interference with the HIV regulatory protein vpr. It showed no detectable anti-HIV vim in clinical trials. It is currently being studied as a treatment for chronic multisymptom disorder. Mifepristone has not been approved by the FDA for any of these uses.

Mifepristone has shown significant effectiveness in psychotic dominating depression, a form of depression resistant to normal treatment. The effect was rapid and the about was double-blinded, but it was limited by small study group and limited treatment duration.

Contraindications

In clinical trials, hardly all women using mifepristone experienced abdominal pain, uterine cramping, and vaginal bleeding or spotting for an normal of 9–16 days. Up to 8% of women experienced some type of bleeding for 30 days or more. Other less stock side effects included nausea, vomiting, diarrhea, dizziness, fatigue, and fever. Pelvic rabble-rousing disease (PID) is a very rare but serious complication. Excessive bleeding and incomplete conclusion of a pregnancy require further intervention by a doctor (such as vacuum aspiration). Between 4.5 and 7.9% of women required surgical intervention in clinical trials. Mifepristone is contraindicated in the aura of an intrauterine device (IUD), as well as with ectopic pregnancy, adrenal failure, hemorrhagic disorders, inherited porphyria, and anticoagulant or great-term corticosteroid therapy.

The FDA prescribing information states that there are no statistics on the safety and efficacy of mifepristone in women with chronic medical conditions, and that "women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with admonition because such patients were generally excluded from clinical trials of mifepristone."

Adverse effects

No eat one's heart out-term studies to evaluate the carcinogenic potential of mifepristone have been performed. Results from studies conducted in vitro and in animals bring into the world revealed no genotoxic potential for mifepristone.

Neonatal exposure to a single large dosage of mifepristone in rats was not associated with any reproductive problems, although chronic low-portion exposure of newborn rats to mifepristone was associated with structural and functional reproductive abnormalities.

Teratology studies in mice, rats and rabbits revealed teratogenicty for rabbits, but not rats or mice. The at all events of birth defects in human infants exposed in utero to mifepristone and misoprostol is simple low, and may be due to misoprostol alone.

Pharmacology

In the presence of progesterone, mifepristone acts as a competitive receptor competitor at the progesterone receptor (in the absence of progesterone, mifepristone acts as a partial agonist). Mifepristone is a 19-nor steroid with a large p -(dimethylamino)phenyl substituent above the plane of the molecule at the 11β-position chargeable for inducing or stabilizing an inactive receptor conformation and a hydrophobic 1-propynyl substituent lower the plane of the molecule at the 17α-position that increases its progesterone receptor binding sympathy.

In addition to being an antiprogestogen, mifepristone is also an antiglucocorticoid and a weak antiandrogen. Mifepristone's germane binding affinity at the progesterone receptor is more than twice that of progesterone, its pertinent binding affinity at the glucocorticoid receptor is more than three times that of dexamethasone and more than ten times that of cortisol, its proportionate binding affinity at the androgen receptor is less than one third that of testosterone. It does not difficult situation to the estrogen receptor or the mineralocorticoid receptor.

Mifepristone as a regular contraceptive at 2 mg daily prevents ovulation (1 mg common does not). A single preovulatory 10 mg dose of mifepristone delays ovulation by 3 to 4 days and is as possessions an emergency contraceptive as a single 1.5 mg dose of the progestin levonorgestrel.

In women, mifepristone at doses greater or counterpart to 1 mg/kg antagonizes the endometrial and myometrial effects of progesterone. In humans, an antiglucocorticoid effect of mifepristone is manifested at doses greater or like to 4.5 mg/kg by a compensatory increase in ACTH and cortisol. In animals, a weak antiandrogenic carry out is seen with prolonged administration of very high doses of 10 to 100 mg/kg.

In medical abortion regimens, mifepristone blockade of progesterone receptors as the crow flies causes endometrial decidual degeneration, cervical softening and dilatation, release of endogenous prostaglandins and an rise in the sensitivity of the myometrium to the contractile effects of prostaglandins. Mifepristone induced decidual analysis indirectly leads to trophoblast detachment, resulting in decreased syncytiotrophoblast production of hCG, which in wind causes decreased production of progesterone by the corpus luteum (pregnancy is dependent on progesterone construction by the corpus luteum through the first 9 weeks of gestation--until placental progesterone stage has increased enough to take the place of corpus luteum progesterone production). When followed sequentially by a prostaglandin, mifepristone 200 mg is (100 mg may be, but 50 mg is not) as chattels as 600 mg in producing a medical abortion.

Legal status

United States

Roussel Uclaf did not ask for U.S. approval, so U.S. availability was not an initial possibility. The first Bush administration banned importation of Mifepristone for adverse use in 1989, a decision supported by Roussel Uclaf. In 1994, Roussel Uclaf gave the U.S. cure rights to the Population Council in exchange for immunity from any product liability claims. The Folk Council sponsored US clinical trials. The drug went on approvable status from 1996. Handiwork was intended to begin through the Danco Group in 1996 but they withdrew tersely in 1997 due to a corrupt business partner, delaying availability again. Mifepristone was approved for abortion in the U.S. by the FDA, in September 2000, during the closing months of President Bill Clinton's administration. It is legal and available in all 50 states, Washington D.C., Guam and Puerto Rico. Medical abortions as a share of total abortions in the United States have increased every year since the concurrence of mifepristone: 1.0% in 2000, 2.9% in 2001, 5.2% in 2002, 7.9% in 2003, 9.3% in 2004 (14.2% of those less than 9 weeks gestation); although materials is limited by eleven states not reporting statistics to the Centers for Disease Control and Fending (CDC) (including California where an estimated >23% of total U.S. abortions were performed in 1997).

Subsection H

Some drugs are approved by the FDA subsumed under sub-section H, which has two sub-parts. The first sets forth ways to rush experiential drugs, such as aggressive HIV and cancer treatments, to market when speedy blessing is deemed vital to the health of potential patients. The second part of sub-section H applies to drugs that not at worst must meet restrictions for use due to safety requirements, but also are required to meet postmarketing observation to establish that the safety results shown in clinical trials are seconded by use in a much wider populace. Mifepristone was approved under the second part of sub-section H. The result is that women cannot pick the hypnotic up at a pharmacy but must now receive it directly from a doctor. Due to the possibility of adverse reactions such as unwarranted bleeding which may require a blood transfusion and incomplete abortion which may be short of surgical intervention, the drug is only considered safe if a physician who is capable of administering a blood transfusion or a surgical abortion is within reach to the patient in the event of such emergencies. The approval of mifepristone under Subsection H included a lowering box warning.

FDA controversy

Many pro-life groups in the US actively campaigned against the affirmation of mifepristone, and continue to actively campaign for its withdrawal. They cite either proper issues with abortion or safety concerns regarding the drug and the adverse reactions associated with it, including passing. The proposed "RU-486 Suspension and Review Act," also known as Holly's Law, was initiated by a town-dweller's petition to the FDA from namesake Holly Patterson's father, and the May 17, 2006 House Subcommittee on Villain Justice, Drug Policy and Human Resources hearing entitled "RU-486 - Demonstrating a Low Type for Women’s Health?”—called by its pro-life chairman Rep. Mark Souder—are the director results of this effort. Religious and pro-life groups outside the US have also protested mifepristone, uncommonly in Germany and Australia.

A small but vocal group of female scientists from the Massachusetts Inaugurate of Technology's Institute on Women and Technology issued a report under the name of "Feminist Global Network of Resistance to Reproductive and Genetic Engineering" in the early '90s to express their foe to mifepristone, because "We felt what was being lost in the political debate was how the numb affects women. In contrast with the groups who are anti-feminist and anti-abortion, the Guild on Women and Technology advocates women's rights to abortion and self determination," said Dr. Janice Raymond of FINRRAGE. Additional feminist critics abide, such as Pauline Connor (LI.B.) of Feminists Against Eugenics in England who stated, "What has been presented as a basic, pill-popping exercise is, in fact, an intensely medicalized and painful procedure which can touch up to four clinic visits and last 12 days."

Europe

Mifepristone was approved for use in France in 1988 (prime marketing in 1989), the United Kingdom in 1991, Sweden in 1992, then Austria, Belgium, Denmark, Finland, Germany, Greece, Luxembourg, the Netherlands, Spain, and Switzerland in 1999. In 2000, it was approved in Norway. Serbia and Montenegro approved it in 2001, Latvia in 2002, Estonia in 2003, Albania and Hungary in 2005. In Sweden and the UK, mifepristone is licensed for use with vaginal gemeprost in place of of oral misoprostol. As of seven years ago, more than 620,000 women in Europe had had medical abortions using a mifepristone regimen. In France, the part of medical abortions continues to increase, from 38% of all abortions in 2003 to 42% of all abortions in 2004. In England and Wales, 42% of at cock crow abortions (less than 9 weeks gestation) in 2006 were medical; the part of all abortions that are medical has increased every year for the past 11 years (from 5% in 1995 to 30% in 2006). In Scotland, 77.8% of at the crack abortions (less than 10 weeks gestation) in 2006 were medical; the cut of all abortions that are medical has increased every year for the past 14 years (from 16.4% in 1992 to 59.1% in 2006). In Sweden, 60.6% of at daybreak abortions (before the end of the 12th week of gestation) in 2006 were medical; 56.3% of all abortions in 2006 were medical. In Denmark, mifepristone was in use accustomed to in between 3,000 and 4,000 of just over 15,000 abortions in 2005. Mifepristone is not approved in Ireland, where abortion is felonious, or Poland, where abortion is highly restricted. Clinical trials in Italy sooner a be wearing been constrained by protocols requiring women be hospitalized for three days, and the medicate remains unavailable to the general public. It was approved in Hungary in 2005, but as of 2005 had not been released on the vend yet, and was the target of protests.

Other countries

Mifepristone was banned in Australia in 1996. In last 2005, a Private Member's bill was introduced to the Australian Senate to lift the ban and give the power of approval to the Therapeutic Goods Administration (TGA). The move caused much ruminate over in the Australian media and amongst politicians. The Bill passed the Senate on 10 February 2006 , and whilst mifepristone is now authorized for use in Australia, as of yet, no drug company has applied to import and distribute it. Currently there are solitary a couple of known instances where a doctor has applied to the TGA for dispensing mifepristone in specified cases. In New Zealand, pro-choice doctors established an import company, Istar, and submitted a solicit for approval to MedSafe, the New Zealand pharmaceutical regulatory agency. After a court case brought by Aright to Life New Zealand failed, use of mifepristone was permitted.

The drug was approved in Israel in 1999.

Clinical trials of mifepristone in China began in 1985. In October 1988, China became the ahead country in the world to approve mifepristone. Chinese organizations tried to purchase mifepristone from Roussel Uclaf, who refused to handle it to them, so in 1992 China began its own domestic production of mifepristone. In 2000, the payment of medical abortion with mifepristone was higher than surgical abortion and the interest of medical abortions varied greatly, ranging from 30% to 70% in cities to being scarcely nonexistent in rural areas. A report from the United States Embassy in Beijing in 2000 said mifepristone had been a great extent used in Chinese cites for about two years, and that according to press reports a coal-black market had developed with many women starting to buy it illegally (without a drug) from private clinics and drugstores for about $15, causing Chinese authorities to be fearful about medical complications from use without physician supervision.

In 2001, mifepristone was approved in Taiwan. Vietnam included mifepristone in the Nationwide Reproductive Health program in 2002.

It is approved in only one subsaharan African country--South Africa, where it was approved in 2001. It is also approved in one north African surroundings--Tunisia, also in 2001.

Mifepristone was approved for use in India in 2002, where medical abortion is referred to as "Medical Stop of Pregnancy" (MTP). It is only available under medical supervision, not by prescription, due to adverse reactions such as disgusting bleeding, and there are criminal penalties for buying or selling it on the black market or ended-the-counter at pharmacies.

Medical abortion is available in Canada on a limited basis using methotrexate and misoprostol; mifepristone is not legally approved, and importation of that dose in Canada is currently illegal. Clinical trials were done in 2000 in a variety of Canadian cities comparing methotrexate to mifepristone, after approbation by the federal government. While both drugs had all-embracing similar results, mifepristone was found to act faster. As of May 2005, it is unclear whether or when RU-486 intent be approved for use in Canada.

Mifepristone was registered for use in Russia and Ukraine in 2000, and in Azerbaijan, Belarus, Georgia, and Uzbekistan in 2002, Moldova in 2004, and Armenia in 2007.

Notes and references

1. ^ Julie A. Hogan (2000). "The Individual of the Abortion Pill in the United States". Legal Electronic Document Archive, Harvard Law Coterie . http://leda.law.harvard.edu/leda/search/toc.php3?handle=HLS.Library.Leda/hoganja-spark of life_abortion_pill . Retrieved on 2006-09-14 .  
2. ^ ^{a b} Exelgyn Laboratories (February 2006). "Mifegyne UK Summary of Output Characteristics (SPC)" . http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=617 . Retrieved on 2007-03-09 .  
3. ^ "Chinese to Correct RU-486 for U.S.". Washingtonpost.com . 2000 . http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A53938-2000Oct11 . Retrieved on 2006-08-22 .  
4. ^ Spitz IM, Bardin CW, Benton L, Robbins A (1998). "At the crack pregnancy termination with mifepristone and misoprostol in the United States". N Engl J Med 338 (18): 1241–7. doi: 10.1056/NEJM199804303381801 . PMID 9562577.  
5. ^ Suzanne Daley (October 5, 2000). "Europe Finds Abortion Pill is No Wizardry Cure-All". The New York Times . http://query.nytimes.com/gst/fullpage.html?sec=fettle&res=9F03E3D61F3DF936A35753C1A9669C8B63 . Retrieved on 2006-09-16 .  
6. ^ RCOG (2004) (PDF). The Care of Women Requesting Induced Abortion : Facts-based clinical guideline number 7 . London: RCOG Press. ISBN 1-904752-06-3 . http://www.rcog.org.uk/resources/Community/pdf/induced_abortionfull.pdf .  
7. ^ Piaggio G et al (2003). "Meta-analysis of randomized trials comparing another doses of mifepristone in emergency contraception". Contraception 68 (6): 447. doi: 10.1016/S0010-7824(03)00142-2 . PMID 14698075.  
8. ^ Wertheimer, Randy E. ( 2000-11-15 ). "Crisis Postcoital Contraception" (HTML). American Family Physician (American Academy of Next of kin Physicians) . http://www.aafp.org/afp/20001115/2287.html . Retrieved on 2006-07-23 .  
9. ^ Gemzell-Danielsson, K.; Marions, L. ( 2004-06-10 ). "Mechanisms of vim of mifepristone and levonorgestrel when used for emergency contraception" (HTML). Human Duplication Update (Oxford University Press) 10 (4): 341–348. doi: 10.1093/humupd/dmh027 . PMID 15192056.  
10. ^ Flexner, Charles. “HIV psychedelic development: the next 25 years”. Nat Rev Drug Discov. 2007 Dec;6(12):959-66.
11. ^ ^{a b} Schimmer, Bernard P.; Parker, Keith L. (2006). "Adrenocorticotropic Hormone; Adrenocortical Steroids and Their Mock Analogs; Inhibitors of the Synthesis and Actions of Adrenocortical Hormones". in in Brunton, Laurence L.; Lazo, John S.; Parker, Keith L. (eds.). Goodman & Gilman's The Pharmacological Base of Therapeutics (11th ed. ed.). New York: McGraw-Hill. pp. 1587–1612. ISBN 0-07-142280-3.  
12. ^ ^{a b} Chabbert-Buffet N, Meduri G, Bouchard P, Spitz IM (2005). "Particular progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications". Hum Reprod Update 11 (3): 293–307. doi: 10.1093/humupd/dmi002 . PMID 15790602. Comments

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