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February 9, 2012 |
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Mifepristone is a synthetic steroid. It is used medically in humans as an abortifacient, for the chemical abortion of early pregnancy. In the United States it is made by Danco Laboratories under the tradename Mifeprex. During early trials, it was known as RU-486 after its designation at the Roussel Uclaf company. Mifepristone is a white powder, highly soluble in methanol and only poorly soluble in water. Its structural name is 11??-p-(Dimethylamino)phenyl-17??-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one. Its empirical formula is C<font size="-2"><sub>29</sub></font>H<font size="-2"><sub>35</sub></font>NO<font size="-2"><sub>2</sub></font> It is used in the termination of pregnancies less than sixty-four days from Fertilisation|conception. A typical dose is 200 mg orally, followed after 48 hours by 800 ??g misoprostol, a prostaglandin analogue, given orally or vaginally. Within four hours of the second dose, it is between 92% and 99% effective (depending on the trial data examined), while as a standalone agent it is approximately 80% effective. This accuracy of this rate of effectiveness is complicated by the fact that a miscarriage occurs spontaneously in over 30% of all pregnancies. It works by competitive interaction with both endogenous and exogenous progesterone at receptor sites. It also has slight antiglucocorticoid and antiandrogenic effects in larger doses. It is contraindication|contraindicated in cases of ectopic pregnancy, adrenal failure, hemorrhagic disorders, anticoagulant or corticosteroid therapy. Side effects include an expected amount of abdominal pain and vaginal bleeding, with the possibility of nausea, vomiting and fever. Incomplete termination of a pregnancy would require further intervention by a doctor (such as Manual vacuum aspiration|vacuum aspiration). In number of deaths of the pregnant woman, mifepristone abortions compare similarly to Manual vacuum aspiration|vacuum aspiration abortion, http://www.religioustolerance.org/aboru486.htm although this comparison compares the rate of death in Manual vacuum aspiration|vacuum aspiration abortion for both early and late term abortions (the later the abortion, the higher the risk of death). When compared to similar term abortions, the rate of death to the pregnant woman is double that of Manual vacuum aspiration|vacuum aspiration abortion. On July 18, 2005, Danco Laboratories admitted that there have been five deaths of women due to bacterial infection following treatment with RU-486 in the previous five years http://www.medpagetoday.com/OBGYN/Pregnancy/tb/1383. The death cases were presumably related to vaginal application of the misoprostol, which is an "off-label use" but practised by abortion clinics. http://www.cnn.com/2005/HEALTH/07/20/abortion.pill.ap/ The compound was discovered by researchers at Roussel Uclaf of France in 1980 while studying glucocorticoid receptor antagonists. Clinical testing began in 1982. It was first licensed in France in 1988, for use in combination with prostaglandin. Then on October 26 of that year, Roussel Uclaf stated that it would abandon distribution of the drug. It bowed to pressure from the government of France two days later to resume distribution. Mifepristone was approved in a number of other European countries as well, starting with the United Kingdom and Sweden in 1991 and followed by Germany in 1992 and most other European countries in 1999. Early research was difficult, as Roussel Uclaf did not seek U.S. approval. It was further interrupted when the first George H. W. Bush|Bush administration banned the importation of mifepristone in 1989. This ban was not reversed until 1993. In 1994, Roussel Uclaf gifted the U.S. drug rights to the Population Council and the drug went on approvable status from 1996. Production was intended to begin through the Danco Group in 1996 but they withdrew briefly in 1997, delaying availability again. It was approved by the U.S. Food and Drug Administration (FDA) in September 2000. Mifepristone was effectively banned in Australia in 1996. As part of a compromise to ensure conservative Tasmanian independent Senator Brian Harradine's support for the part sale of Telstra, the law was ammended to provide that approval of the drug would require the consent of the Health Minister, in addition to the normal processes of drug approval by the TGA. This constituted an effective ban since no company would be willing to invest in the expense of the TGA approval process if all that work could be nullified by the politcally-motivated whim of a conservative Health Minister. As of late 2005, the Australian Democrats have introduced an amendment in the Senate to remove this statutory provision; its success will likely depend on whether the conservative governing Liberal party agrees to give its members a conscience vote on the issue. Mifepristone has been investigated in the treatment of Cushing's syndrome, endometriosis, and a number of cancers.
Category:Abortifacients Category:Antiandrogens Category:Antiglucocorticoids cs:Mifepriston de:Mifepriston fr:Mif??pristone hu:Mifepriston This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Mifepristone".
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