RU-486 and misoprostol can be used only for very early abortions. [See box at right for how to calculate pregnancy]
After the 7th week of pregnancy, effectiveness drops below a level the FDA considers safe.4 [More]
92% of women taking RU-486/misoprostol through the 7th week of pregnancy had a complete abortion.5
But only 77% of women taking RU-486 in the 9th week LMP had a complete abortion.6
How to calculate length of pregnancy
Doctors calculate the length of pregnancy by counting from the first day of the last menstrual period (LMP), that is, about two weeks prior to conception (fertilization). So "up to 49 days LMP" means up to 5 weeks after conception.
Result: About 8% of U.S. women who take RU-486 and misoprostol through the 7th week "will need a surgical procedure to end the pregnancy or stop too much bleeding."7
In U.S. trials, a "total of 295 patients were classified as having failed ... abortion. Of these patients, 79 (27%) had ongoing pregnancies, 126 (43%) had incomplete abortions, 30 (10%) requested and had surgical terminations, and the remaining 60 (20%) patients had surgical terminations performed because of medical indications,"8 for example, due to uncontrolled hemorrhaging.
Risks from a failed or incomplete abortion:
Infection and death9 A woman participating in RU-486 trials in Canada died on September 1, 2001 from such an infection.10 [More]
Uncontrolled bleeding, possibly death11
Dr. Mark Louviere, an emergency room doctor who treated a Waterloo, Iowa woman 2 weeks after she took RU-486, testified that she bled nearly to death.
Misoprostol has been linked to "a high rate of birth defects ... such as fused joints, growth retardation and a paralysis of the face called Moebius syndrome."12 [More]
4 The U.S. Food and Drug Administration (FDA) advises: "Do not take mifepristone [RU-486] if it has been more than 49 days since your last menstrual period [began] ...." (FDA Center for Drug Evaluation and Research, "Mifepristone Questions and Answers," available at http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa.htm)
"During the first few weeks of a pregnancy, a woman's ovaries produce progesterone, but by the ninth or tenth weeks ... the placenta begins to produce progesterone in larger amounts, which is why anti-progestins like mifepristone are not as effective later in pregnancy" (Kaiser Family Foundation, "Issue Update: Mifepristone: An Early Abortion Option," July 2001,at 4, note 8).
5 I. Spitz et al., supra note 2, at 1242-1243.
6Ibid. "The largest increase in failures was in failures representing ongoing pregnancy, which increased from 1 percent in the = 49 group to 9 percent in the 57-63 days group (p<0.0001)" (I. Spitz, et al., supra note 3, at 1241.
7 FDA Center for Drug Evaluation and Research ("CDER"), "Mifepristone Medication Guide," available at http://www.fda.gov/cder/drug/infopage/mifepristone/medguide.htm.
8 FDA CDER, "Medical Officer's Review of ... Final Reports for the U.S. Clinical Trials Inducing Abortion ..."("Medical Officer's Review"), Nov. 22, 1999, at 11.
9 See, e.g., Cytotec label, revised and approved by the FDA on June 22, 2000, which states in part: "Miscarriages caused by Cytotec may be incomplete, which could lead to dangerous bleeding, hospitalization, surgery, infertility, or maternal or fetal death."
10 RU-486 Canadian drug trials were suspended following the September 1, 2001 death of a woman from toxic shock brought on by a bacterial infection related to her abortion. She died just 10 days after taking RU-486. S. Schmidt, "Woman's death sparks abortion pill debate," National Post (Canada), Sept. 17, 2001, at A13.
11 An emergency room doctor, Mark Louviere, M.D., described treating a woman from Waterloo, Iowa who participated in RU-486 trials at the local Planned Parenthood clinic. Two weeks after her RU-486/misoprostol abortion, she was taken to a hospital emergency room where Dr. Louviere found her "in obvious shock" having "lost between one-half to two-thirds of her blood volume. ... It was my clinical opinion that she would die soon. ... 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" (Testimony of Dr. Mark Louviere before FDA Reproductive Health Drugs Advisory Committee, Hearing Transcript, July 19, 1996, at 224).
12 Agence France Presse, Aug. 29, 2001, reporting on an article in the British weekly, New Scientist, Sept. 1, 2001. The Mifepristone Medication Guide, supra note 7, warns that if the pregnancy has not ended, "there is a chance that there may be birth defects ... [and] your provider will talk with you about other choices you have, including a surgical procedure to end your pregnancy." Misoprostol is responsible for a "minor epidemic of birth defects" in developing countries, according to the New Scientist article. Poor women are taking this ulcer medication to induce abortion. Taken alone it results in abortion only 40% of the time. The referenced Agence France Presse English report (Aug. 29, 2001) states: "Doctors have discovered a high rate of birth defects among infants exposed in utero to misoprostol, such as fused joints, growth retardation and a paralysis of the face called Moebius syndrome. In Brazil, where up to 75 percent of the clandestine abortions involve misoprostol, studies suggest between a third and a half of infants born with Moebius had been exposed to misoprostol, New Scientist says."