Chemical Abortions

RU-486/Misoprostol: The French Abortion Pill & Methotrexate/Misoprostol Combination Abortions

Current Status

RU-486/Misoprostol

On September 24, 2000, the FDA approved the use of RU-486, an abortion drug. This Newest chemical abortion process available in America uses a two-drug regimen. RU-486, sold under the name Mifeprex, works by blocking the hormone progesterone, which is vital to the fetus. The second drug, misoprostol, is produced by Searle Pharmaceuticals. The drug was originally manufactured to treat ulcers, but in this chemical abortion process, it will be used to cause the uterus to contract and expel the dead fetus. Without the second drug, the abortion cannot be completed. However, Searle does not want its drug to be used to perform abortions, which may hold up the use of this chemical abortion procedure. Before RU-486 was even approved, Searle Pharmaceuticals sent out a letter, with the cooperation of the FDA, saying misoprostal "is not approved for the induction of labor or abortion." The letter told about the adverse affects that may be caused by use in these situations, such as a ruptured uterus, vaginal bleeding, and "maternal or fetal death." The FDA has now approved the use of misoprostol in conjunction with RU-486 to perform abortions, but Searle remains committed to its stance to protect women.

The FDA changed its stance on several issues related to RU-486 in the months before its approval of the drug. The requirements that were actually approved by the FDA in September are much less stringent than those that were being considered in June., According to news summaries about the proposed requirements.

 

Proposed Requirements - June 2, 2000 - for more info click here

1. Monitored distribution
2. Prescription by physicians only
3. Require training in the use of the drug
4. Require physicians to be trained in ultrasound reading
5. Limit use to doctors with surgical abortion experience or training
6. Limit use to doctors with admitting privileges to hospitals with emergency services within an hour's drive of the doctor's office.
7. Follow-up studies / long-term tracking on health of women taking RU-486

Approved Requirements - September 24, 2000 - for more info click here

1. Will only be distributed to physicians who can determine duration of pregnancy and ectopic pregnancy
2. Can be prescribed by health care practitioners
3. Must have arrangements with a surgeon in case of problems

Over the course of only a few months, the FDA decided that several of its proposed requirements, such as training, ultrasounds, and physician-only prescriptions were no longer necessary. The FDA also decided that misoprostol was not as dangerous to pregnant women as it had originally supported in Searle Pharmaceuticals letter describing the dangers of taking misoprostol to pregnant women.

The raw components of RU-486 will be manufactured by Shanghai-based Lian Pharmaceutical Co. and the marketing of the drug will be done by Manhattan-based Danco Laboratories.

Methotrexate/Misoprostol (Cytotec)
On August 30, 1995 the New England Journal of Medicine released a study indicating that the combined use of methotrexate (a cancer chemotherapy drug) and misoprostol (Cyctotec, an ulcer drug), work in combination to induce abortions in early pregnancy with about the same effectiveness as the RU-486/prostaglandin technique. Both drugs are already legally available in the U.S. and can be prescribed by doctors using what is called "off-label" prescribing.

On September 11, 1996, Planned Parenthood Federation of America announced that it would be offering this chemical abortion technique on a trial basis at 17 Planned Parenthood locations across the country. The estimated cost of the procedure would be $250 to $350.

History and Background Information
Beginning in June 1989, the U.S. Food and Drug Administration placed a ban on importing RU-486 for personal use. Inadequate testing of the drug, and its known complications made it unsafe for use other than in controlled medical situations. The American Medical Association supported this ban out of concern for women's health.

On January 22, 1993, President Clinton signed an executive order requesting that this policy be re-examined and efforts be made to accelerate the importation of RU-486. The ban on personal use has not prevented research from being done in this country for other possible uses of the drug. On May 1, 1993 a news release reported that clinical trials would begin soon in Portland, Oregon.

RU-486 On May 17, 1994, Roussel-Uclaf, the developer of RU-486, donated its U.S. patent rights to the pro-abortion Population Council. By fall 1994 testing of the chemical abortion process was begun at about a dozen locations across the country.

On July 19, 1996 an advisory committee of the U.S. Food and Drug Administration recommended that RU-486 receive full FDA approval for use as a nonsurgical abortion technique. Despite examples of specific risks to women, including excessive bleeding, the panel advised that the "benefits" outweighed the risks.

In September 1996, the U.S. Food and Drug Administration declared RU-486 safe and effective for abortion but stated that they were waiting on additional information about labeling and manufacturing before giving the drug final approval.

On November 4, 1996, the Population Council, which holds the patent rights for RU-486 and Advances in Health Technologies (AHT) a front organization established to market it, announced that they were suing businessman Joseph Pike, a disbarred attorney recently convicted in North Carolina, for fraud. Pike had contracted the manufacturing and distribution rights from AHT. The groups indicated that Mr. Pike had not been forthright about his circumstances or ability to uphold his obligations. They also expressed concern that the legal battle could slow the availability of RU-486 if it received FDA approval promptly.

In February 1997, Gideon Richter, the company that was contracted to make RU-486 available to the general public, attempted to back out of the contract.  Advances for Choices and Danco Laboratories subsequently filed a lawsuit to force Gideon Richter to follow through with their contract.  Marketing plans for RU-486 were temporarily put on hold. 

On December 27, 1999, Rhode Island became the latest state in the country to approve chemical abortions. The change allows health care workers other than physicians to prescribe the medicine. The Rhode Island State RTL committee blasted the new policy, saying new provisions allowing nurse-practitioners, some midwives and supervised physician assistants to prescribe the drugs will endanger women.

Also on April 30, 1998, the New England Journal of Medicine published the results of a trial use of  RU-486 on 2,121 U.S. women.  The research, conducted by abortionist-researchers, attempted to prove the safety and effectiveness of using RU-486 to abort babies up to 49-days gestational age.  Although this information is contradictory to other information about RU-486, the press reported in without hesitation.  Shortly thereafter a spokesperson for the company that is overseeing the distribution and manufacturing the abortion drug told a reporter from the Associated Press that plans are being worked out to see that RU-486 is on the market in 1999.

The RU-486 Abortion Process                                                    RU-486 (Mifepristone) is a synthetic steroid used to induce abortion between the fourth and seventh week of pregnancy. RU-486 is normally used in conjunction with a prostaglandin (like misoprotol) which induces uterine contractions to increase its abortive efficacy (95%). Taken alone RU-486 can have a 20%-40% failure rate.

RU-486 works by inhibiting the natural functions of the hormone progesterone. Progesterone is produced in the ovaries and helps the endometrium (uterine lining) nurture the embryonic child. Because RU-486 resembles progesterone, but does not function like it, the endometrium breaks down, and thus it, and the growing child is shed from the uterus.Taking RU-486 induces the miscarriage of pregnancy, it does not simply induce menstruation.

The process of an RU-486 abortion, though not surgical, is nonetheless arduous. Women must make three or four trips to the abortion facility. Taking RU-486 is followed up two or three days later with a trip to take the prostaglandin drug. At a minimum, a third trip is required to confirm that the abortion has occurred. A particularly disturbing aspect of an RU-486 abortion is that women may expel their unborn children at home, often being alone, and sometimes being able to identify the developing child amid the uterine contents they miscarry.

RU-486: Complications and Long-term Effects
Use of RU-486 does not come without dangers. Prolonged bleeding, severe cramping, nausea, diarrhea, headache, skin rash and vomiting are common side effects. About 5% of the women bleed so heavily that a D&C or other treatment is required. Two women taking the drug have had heart attacks, another woman died, prompting the French government to review the drug's use for older women and smokers.

For about 5% of the women using the RU-486/misoprostol technique, the abortion fails to occur. These women must then have a surgical abortion. Medical evidence indicates that a child which is not aborted by RU-486 faces the possibility of malformations due to the drug. In Europe, women taking RU-486 are often required to sign a form requiring them to obtain a surgical abortion if the drug fails.

The study done here in the United States on RU-486 was conducted on women ages 28 to 45 years. Despite the fact that the FDA does not know the effects of RU-486 on women under 18, the drug will be available to them.

The long-term effects of RU-486 are completely unknown. It does have chemical properties similar to DES, a drug taken for miscarriages in the 1960s and 1970s, which has had serious long-term effects on women's health. No information is available about repeated exposure to RU-486. If the pattern for surgical abortions (a repeat rate of 47%) is assumed for RU-486, women may end up taking the drug repeatedly.

RU-486 as a Contraceptive
In October 1992 the media reported on a few medical studies which reported that RU-486 is also effective as a "morning-after" contraceptive pill. Researchers claim that taking the drug within 72 hours of having unprotected intercourse, RU-486 prevented any fertilized eggs from implanting in the uterus. Of course, a drug that works after conception to prevent pregnancy is not a contraceptive, but rather an abortifacient. Thus, even if RU-486 works to prevent implantation, its effect is still to deny the natural life process to a developing, human being.

Other Uses for RU-486
On March 19, 1993 a representative from Searle, the parent company of the manufacturer of Cytotec stated that the company never willingly agreed to make Cytotec available for use in the making of RU-486 for abortions. Cytotec was developed for the prevention of ulcers. They strongly oppose its use with RU-486 in abortions.

Proponents of RU-486 have touted its potential as treatment for breast and brain cancer, endometriosis, adrenal gland disorders, even AIDS. To date, however, RU-486 has not been proven effective for these purposes. Research into these areas is ongoing, and the prolife movement has no objection to this research. What is known about RU-486 is its effectiveness in destroying pre-born human beings.

Methotrexate/Misoprostol Process
The methotrexate is given to a women no more than 7 weeks pregnant by injection. The drug works by stunting development of the unborn child and placenta. Four to seven days later, misoprostol tablets are inserted into the vagina to induce uterine contractions, expeling the unborn child. Side effects of the methotrexate include vomiting, nausea, and diarrhea. Misoprostol bring on cramping and bleeding and can be accompanied by nausea and vomiting.