Most people have heard of the abortion pill, RU-486. Mifepristone is the generic name for RU-486, which was developed in 1980 by the French pharmaceutical company Roussel Uclaf. Mifepristone is the first in a two-drug chemical abortion technique given to women who are up to seven weeks (or 49 days gestational age) pregnant. First, a woman is given mifepristone, which acts to block progesterone — a hormone necessary to maintain pregnancy. Mifepristone causes the uterine lining to shed, disconnecting (and in essence starving to death) the developing preborn child. A second drug, misoprostol, is taken a day or two later and causes the womb to expel the now-dead embryo. Taken in tandem, the two drugs cause an induced abortion.
On September 28, 2000, mifepristone was approved by the U.S. Food and Drug Administration (FDA) for use in chemical abortion under the brand name Mifeprex®. The companion drug, misoprostol, was already available in the U.S. as a treatment for ulcers. The second drug in this chemical abortion, misoprostol, is manufactured by Searle Pharmaceuticals under the brand name Cytotec®. In July 2002, the FDA approved a generic version of misoprostol distributed by IVAX Pharmaceuticals.
The FDA has never formally approved misoprostol for use in chemical abortion, although it recommends misoprostol for use in conjunction with mifepristone. Searle, a subsidiary of Pharmacia Corporation, has not studied or approved Cytotec (misoprostol) for use in labor induction or abortion.
However, one month before FDA approval for the abortion drug combination, Searle issued an alert to physicians, warning that misoprostol is not approved for use in pregnant women and that using the drug can cause “rupture or perforation requiring uterine surgical repair, hysterectomy,” “severe vaginal bleeding” and “maternal death.”1 The FDA reports 35 uterine ruptures and 10 infant deaths linked to misoprostol between 1988 and 2000.2 Since 1997, misoprostol is blamed for the deaths of two women who received the drug and then died during or after childbirth.3 A third woman died in May 2006 after taking misoprostol for a chemical abortion.4 Despite Searle’s warning and these deaths, the drug is often used by physicians to induce childbirth.
Mifeprex is the first drug legally prescribed in the U.S. for the sole purpose of ending a human life. It is not a contraceptive, as it is used after the mother knows she is pregnant and the preborn baby is developing in her womb.5
What Are the Risks to Women Who Take Mifepristone for a Chemical Abortion?
Death
In the United States, at least six women have died in connection with the abortion drug combination — five died from infection and a sixth from a ruptured tubal pregnancy.6 In response, the FDA in July 2005 announced the second change to the drug’s “black box” warning label detailing the symptoms associated with the fatal bacterial infections. The “black box” is the FDA’s most serious warning label. The agency also issued an advisory update on the drug in April 2006, detailing warning signs associated with infection.7
The mifepristone warning label was previously updated in November 2004 with a warning of serious bacterial infections after the death of 18-year-old Holly Patterson. In November 2003, the Alameda, California, coroner’s office reported that Patterson died from septic shock, caused by a “therapeutic, drug-induced abortion.” Patterson died September 17, 2003 — seven days after receiving mifepristone at the Haywood California Planned Parenthood affiliate.8 In December 2004, her parents filed suit against the drug’s distributor, Danco Laboriatories, Planned Parenthood and the hospital where she died.9
The families of two other women who died of infections after taking mifepristone — 21-year old Hoa Truy "Vivian" Tran who died in 2003 and 22-year old Chanelle Bryant who died in 2004 — have joined the Patterson's in their lawsuit against Danco.10
Another California woman — 34-year old Oriane Sevin of Los Angeles -- died in May 2005 after taking Mifeprex.11
In May 2006, the Baltimore Sun quoted an FDA oficial reporting that an unidentified fifth U.S. woman "died of septic shock after taking the abortion pill, but she had an infection different from the Clostridium sordellii infection linked to the other deaths."12
The multiple deaths due to infection raise questions about the drug's safety, including one article published in a medical journal theorizing that “the mechanisms of mifepristone action favor the development of infection that leads to septic shock . . . resulting in . . . lethal septic shock.”13
The family of a sixth woman, 38-year-old Brenda Vise of Tennessee, filed a medical malpractice lawsuit against the abortion clinic that gave Vise mifepristone, alleging that failure to correctly diagnoses her ectopic (or tubal) pregnancy caused her death five days after taking the drug.14
In other countries:
- A Swedish teenager bled to death after receiving the drug in March 2004.15
- A Canadian woman died after in September 2001 during clinical trials for RU-486.16
- Three British women have died after taking the drug since 1991.17
Side Effects and Complications
A 2006 analysis of adverse drug reactions found more than 600 serious side effects to the drug were reported to the FDA between September 2000 and September 2004. These included more than 200 instances of life-threatening or serious hemorrhages and 46 instances of infection — four of which were life-threatening. Seventeen cases of undiagnosed ectopic pregnancies were reported, eleven of which ruptured. 18
One woman, Dana Powell of Ohio, filed suit against the Akron Women’s Center for Choice in April 2004, claiming that the mifepristone/misoprostol combination given to her for an abortion in 2002 coupled with the misdiagnosis of her ectopic pregnancy (that later ruptured) left her unable to conceive.19
Some of these deaths and complications were reported to the FDA by the drug’s distributor in accordance with federal law. Critics, however, say that the negative side effects of mifepristone are probably under-reported, as physicians are not required to report problems to drug manufacturers.20
Even before the release of data documenting deaths and complications, supporters of mifepristone acknowledged that the chemical abortion it triggers is not a quick and easy process. Common side effects are potentially serious and include abdominal pain, nausea, vomiting, diarrhea and vaginal bleeding. Five to eight percent of women require a follow-up surgical abortion because the chemical abortion fails.21
During the U.S. clinical trials, at least one woman hemorrhaged so severely that she lost one-half of her blood and nearly died due to the drug’s use.22
One published study based on the U.S. clinical trials of mifepristone found that “[E]xcessive bleeding necessitated blood transfusions in four women and accounted for 25 of 27 hospitalizations (including emergency-room visits), 56 of 59 surgical interventions, and 22 of 49 administrations of intravenous fluid.” The study states that one in 100 women reported symptoms ranging from bleeding to abdominal pain and vomiting that they described as severe and incapacitating.23
Byron C. Calhoun, M.D., with the American Association of Pro-Life Obstetricians and Gynecologists, states, “We can foresee many significant problems that women will encounter should medical abortion become an accepted standard of care. From the clinical trials, we have a generally good idea of the complication rates, which we believe are unacceptably high. One can only imagine the thousands of young women who have taken mifepristone who will be sitting at home wondering how much bleeding is too much.”24
Who Is Manufacturing the Drug for U.S. Markets?
The Population Council and Danco Laboratories, the U.S. company formed to distribute mifepristone, were unable to identify a U.S.-based pharmaceutical company willing to manufacture the drug. So, they turned overseas to Communist China, where Danco signed a contract with the state-owned Shanghai Hua Lian Pharmaceutical Co. Ltd. Congressional investigators say the Chinese company and its Shanghai plant have been cited by federal regulators for bringing mislabeled and impure drugs into the United States.25
How Does a Chemical Abortion, Like RU-486, Differ From a Surgical Abortion?
The chemical abortion differs from surgical abortions in several respects:
- Rather than relying on an abortionist to kill her preborn child, the chemical abortion requires the mother to end her pregnancy by her own hand.
“By taking the pills, women are performing their own abortion,” says French gynecologist Elisabeth Aubeny.26
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In a surgical abortion, the mother usually does not see her aborted child. However, with a chemical abortion, it’s not uncommon for the mother to see her aborted preborn child as he or she passes out of the mother’s body.
“I looked at the fetus and was disgusted. I flushed before I got sick to my stomach.”27
“There is a fist-size glob of red and white at the bottom of the toilet. Becky can see the curled up-fetus... Its hands are curled into tiny fists.”28
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In the eyes of some physicians, chemical abortion does not carry the stigma of surgical abortion. A Kaiser Family Foundation survey found that 31 percent of gynecologists and family practice physicians who do not perform abortions say they are at least “somewhat likely” to prescribe mifepristone.29
Does a Chemical Abortion Cost Less Than a Surgical One?
No. The cost of a chemical abortion is between $75 to $130 more than a surgical abortion.30
How Do Americans View the Availability of Mifepristone in the United States?
A public opinion poll, conducted by Gallup, found that opposition to mifepristone as an abortion drug increased from 44 percent in 1996 to 47 percent in 2000.31
Is the “Morning-After Pill” the Same as Mifepristone?
No. Mifepristone is taken when a woman knows she is pregnant and with the intention of aborting her preborn child. On the contrary, the so-called “morning-after pill” is sold to women as a form of “emergency contraception” to prevent pregnancy.
