Mifepristone Drug: To Approve or to Disapprove?

Mifepristone was initially developed during the early 1980s at the French pharmaceutical company Roussel Uclaf. (Creinin MD. Medical abortion regimens: historical context and overview. Am J Obstet Gynecol. 2000; 183: S3-S9.) Mifepristone is a synthetic steroid, an anti-progestin that obstructs the action of progesterone (a hormone necessary to maintain a pregnancy). By doing this, it modifies the uterine lining, stimulating menstrual bleeding, consequently causing the uterine lining to shed by softening the cervix, thereby initiating contractions of the uterus. (Retrieved from website-http://www.fwhc.org/abortion/medical-ab.htm>)

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Allergic reactions

The FDA has issued warnings M/M abortion is not advised to women who are allergic to either drug. (Mifeprex Package). Dr. Wu Shangchun of the National Research Institute for Family Planning in Beijing specifies the need for observation because “The common complications of medical abortion are profuse bleeding and allergy.” Allergic reactions such as manifesting in facial edema, skin rash and itching, numbness of feet and hands, and even a serious case of allergic shock. “The potential for such reactions is one reason to keep clients for observation” (Wu, op. cit., at 198).

Infection

Four percent of women in PC’s U.S. trials reported fever, viral infection, and vaginitis related to abortion. Ten cases of study-related endometritis (inflammation of uterine lining) were also reported (NEJM, op cit. at 1244). “The most common problems reported at follow-up were continued pain, vaginal bleeding, and offensive discharge.” (H. Von Hertzen, “Research on Regimens for Early Medical Abortion,” JAMWA, Supplement 2000, 133, 136).

Failure Rates

The gestational age of the fetus must be precisely determined because failure rates augment significantly after 49 days of LMP, by 17% at 50-56 days and 23% at 57-63 days. (Id. at 1243). Further, abortion that is incomplete and untreated could consequently cause infection, sterility and even death. Added Dangers to Women under the Lax Standards Set by the FDA state that Failure to make a diagnosis of an ectopic pregnancy can result in maternal death. (Wu, op cit., 198-199) “Some recent adverse events resulting from undiagnosed ectopic pregnancies have led providers to pay more attention to ultrasound examination.” (Id. at 197). Malformations in eight children were reported in 71 cases of continuing pregnancy in France, Sweden, and the United Kingdom between 1987 and 1998. (Von Hertzen, op. cit. at 136). (Retrieved from website: <http://www.usccb.org/prolife/issues/abortion/ru486factsheet.shtml>

Risks to U.S. Women under Relaxed Controls

Bleeding

In U.S. trials conducted by the Population Council (‘PC’), a total of 9% of women reported bleeding after 30 days, and 1% continued to bleed even after 60 days. “Excessive bleeding necessitated blood transfusions in four women and accounted for 25 of 27 hospitalizations (including [ER] visits), 56 of 59 surgical interventions, and 22 of 49 administrations of [IV] fluid” (I.M.Spitz et al., “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” The New England Journal of Medicine, April 30, 1998, 338:18, 1241-47, hereinafter ‘NEJM’).

A Waterloo, Iowa woman participating in Population Council trials had to be urgently taken to a hospital emergency room where Dr. Louviere found her “in obvious shock” as she had “lost between one-half to two-thirds of her blood volume.” His clinical opinion was that she would die soon. He further informed that “without even doing the routine preparation we normally do for surgery, I realized that I had to take her immediately to surgery to save her life” (FDA Reproductive Health Drugs Advisory Committee, Hearing Transcript, July 19, 1996, at 224).

Two patients in Des Moines, Iowa trials reported to a TIME magazine journalist stating that their bleeding was “like turning a jug of water upside down” and “like a faucet was turned on. There was a steady stream of blood”. They also shockingly revealed that one of them “passed a golf ball size blood clot that scared me” (Sachs, “Abortion Pills on Trial,” TIME, 12/5/94, p. 45).

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According to a news report of Washington (March 29, 2005), an official of the United States Conference of Catholic Bishops (USCCB) expressed continued support for the “RU-486 Suspension and Review Act of 2005,” known as “Holly’s Law.” Holly’s law is named in memory of a young California woman Holly Patterson, who died from toxic shock after undergoing an RU-486 abortion when she had just turned 18. Reportedly eight women are known to have died in the United States after RU-486 abortions.

As per the New England Journal of Medicine (12/1/05), RU-486 abortions are ‘ten times more likely to kill a woman than are surgical abortions in early pregnancy.’ The drug is known to cause maternal fatalities are from “a type of toxic shock syndrome caused by Clostridium sordellii,” thereby putting women who undergo RU-486 abortions at uncalled risks. (Retrieved from website <http://www.usccb.org/comm/archives/2006/06-064.shtml>) After having researched the topic, I, as a responsible human being, would obviously press for the immediate ban of the drug, but one also has to keep in mind that

The life of a fetus cannot be separated from the life of the pregnant woman. This is unique in medicine and law. No one can create a set of medical principles or legal principles giving a right to life to the fetus, because by doing so, inevitably the woman’s rights become limited”. (Retrieved from http://www.fwhc.org/abortion/medical-ab.htm>)

References

Creinin MD. Medical abortion regimens: historical context and overview. Am J Obstet Gynecol. 2000; 183: S3-S9.

H. Von Hertzen, “Research on Regimens for Early Medical Abortion,” JAMWA, Supplement 2000, 133, 136.

FDA Reproductive Health Drugs Advisory Committee, Hearing Transcript, 1996 at 224.

Mifeprex Package, NEJM, op cit. at 1244, New England Journal of Medicine (05).

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Sachs, “Abortion Pills on Trial,” TIME, 94, p. 45.

Spitz I.M., et al., “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” The New England Journal of Medicine, 1998, 338:18, 1241-47, hereinafter ‘NEJM’.

Von Hertzen, op. cit. at 136.

Wu, op. cit., at 198.

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