In the U.S., the most available and used drugs for chemical abortion is a combination of mifepristone (also known as RU-486) and misoprostol.
What is Mifepristone/RU-486?
Mifepristone is the generic name for the over-the-counter drug "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®.
What is Misoprostol?
The second drug used in this chemical-abortion regimen, misoprostol, was already available in the U.S. as a treatment for ulcers when mifepristone was approved for 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.
Misoprostol is not formally approved by the FDA 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.
It's worth noting the drug is linked to uterine rupture and other critical risks to pregnant women. Just one month before FDA approval for the abortion drug combination, Searle issued an alert to physicians, warning them that misoprostol is not approved for use in pregnant women and using the drug can cause "rupture or perforation, requiring uterine surgical repair, hysterectomy," "severe vaginal bleeding" and "maternal death."
What Are The Risks to Women Who Take Mifepristone and Misoprostol to Induce a Chemical Abortion?
As of April 2011, the FDA reported at least 14 women have died in the U.S., due to complications from taking mifepristone and misoprostol for chemical abortion. At least eight deaths have been attributed to a bacterial infection, Colostridium sordellii, most likely caused by vaginal use of misoprostol. The report also lists five additional deaths in foreign countries.
The FDA has updated the warnings associated with mifepristone several times to reflect the risk of fatal clostridial toxic shock from infection. In July 2005, the FDA announced the second change to the drug's "black box" warning label detailing the symptoms associated with the fatal bacterial infections, which can be "atypical ... without fever, bacteria or significant findings on pelvic exam. ..." The "black box" is the FDA's most serious warning label.
The first woman known to die from infection after taking mifepristone for a chemical abortion was 18-year old Holly Patterson. Patterson died Sept. 17, 2003 — about a week after receiving mifepristone at the Haywood, California Planned Parenthood affiliate. An autopsy found Patterson died from septic shock, caused by a "therapeutic, drug-induced abortion." In December 2004, her parents filed suit against the drug's distributor, Danco Laboratories, Planned Parenthood and the hospital where she died.
The FDA's most recent "Adverse Event Summary" on the drug combination chronicles other complications associated with the drugs, including blood loss requiring transfusion, intravenous antibiotics and hospitalization.
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 they described as severe and incapacitating.
How Common are Chemical Abortions in the U.S.?
According to the U.S. Centers for Disease Control's 2010 Abortion Surveillance Report, 20 percent of abortions that year were chemical; 80 percent were surgical.
Is Mifepristone the Same as the "Morning-After Pill"?
No, mifepristone is taken when a woman knows she is pregnant and has the intention of aborting her preborn child. The "morning-after pill" is sold to women as a form of "emergency contraception" to prevent pregnancy.