In September 2000, the United States Food and Drug Administration (FDA) approved mifepristone (brand name, Mifeprex) for early pregnancy termination. Because early medical options like mifepristone can be offered safely in a variety of settings, they offer women a greater degree of privacy and control over the process of terminating an unwanted pregnancy.

Frequently Asked Questions about Mifepristone

How does mifepristone work?

How does a woman take mifepristone to terminate a pregnancy?

Why do some healthcare providers offer mifepristone medical abortion in a different regimen than recommended by the FDA?

What are the benefits to using mifepristone?

What are the side effects?

Who should not use mifepristone?

Who can offer Mifeprex?

Will insurance cover the use of Mifeprex?

How does Mifeprex differ from emergency contraception or the "morning after pill"?

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How does mifepristone work?
Mifepristone terminates a pregnancy by blocking the receptors of the hormone progesterone, which is needed for a pregnancy to continue. It also increases prostaglandin levels and dilates the cervix, facilitating abortion. When followed by administration of misoprostol, a prostaglandin that induces uterine contractions, mifepristone ends an unwanted pregnancy approximately 94–98% of the time.

How does a woman take mifepristone to terminate a pregnancy?
Under the FDA approved regimen for Mifeprex (mifepristone), a woman first takes 600 mg of mifepristone (three 200-mg pills by mouth). Two days later, she takes 400 micrograms (two 200 microgram pills) of misoprostol. Approximately 14 days after taking the mifepristone, she returns to the healthcare provider for a follow-up visit approximately to determine whether the pregnancy has been terminated.

Why do some healthcare providers offer mifepristone medical abortion in a different regimen than recommended by the FDA?
Research and real world experience with mifepristone has shown that alternatives to the FDA-approved regimen are safe, effective, and in most cases, preferable to the FDA regimen. For example, studies indicate that a 200 mg dose of mifepristone is as effective as the 600 mg FDA-approved dosage. A recent study also found that administering misoprostol either one or three days after mifepristone was as effective as the FDA-mandated two-day period. Other acceptable alternatives include extending the use of mifepristone under the approved regimen up to 56 days gestation or offering 200 mg mifepristone with 800 micrograms of misoprostol vaginally to extend the use of medical abortion up to 63 days gestation. Additionally, extensive clinical data support the safety and efficacy of administration of misoprostol at home.

What are the benefits to using mifepristone to terminate a pregnancy?
Abortion using mifepristone has several advantages over surgical abortion. Mifepristone carries no risk of uterine perforation or rare complications caused by anesthesia and lower risk of infection. Many women feel that medical abortion is noninvasive, more natural, and more private than surgical abortion. 1 When given a choice between medical and surgical abortion, 57–70 % of women choose the medical option. 2 96% of women in clinical trials of mifepristone said they would recommend this method to a friend. 3

What are the side effects of mifepristone?
All women who use mifepristone experience bleeding and cramping; both symptoms are normal and part of the medical abortion process. Other side effects include nausea, headache, vomiting, diarrhea, dizziness, back pain and tiredness. These side effects tend to lessen after the third day after taking mifepristone and are usually gone within two weeks. Serious adverse events, like hospitalization or blood transfusions, are extremely rare.

Who should not use mifepristone?
Mifepristone is not appropriate for women who have:

• Ectopic pregnancies
• Intrauterine device in place
• Chronic failure of the adrenal glands
• Porphyria
• Current long-term therapy with corticosteroids
• History of allergy to mifepristone or other prostaglandins
• Bleeding disorders or are undergoing blood-thinning therapy

Who can offer mifepristone medical abortion in the United States?
Mifeprex (mifepristone) is only available to qualified physicians who establish an account with Danco Laboratories, the manufacturer of the drug (www.earlyoptionpill.com). Physicians who prescribe Mifeprex must be able to assess the duration of the pregnancy accurately, diagnose ectopic pregnancies, and provide surgical intervention in cases of incomplete abortion or severe bleeding — or have made plans to provide such care at other medical facilities.

Will insurance cover the use of mifepristone for medical abortion?
Many of the nation's largest health insurers routinely cover Mifeprex, in the way other drugs or surgical abortions are already reimbursed. Mifeprex will also likely be covered by those states which currently cover abortion services.

How does mifepristone differ from emergency contraception or the "morning after pill"?
Emergency contraceptive pills (ECPs) are the most common method of preventing pregnancy after unprotected sexual intercourse. The use of emergency contraceptive pills does not cause an abortion. If a woman wants to prevent pregnancy after sex, she can use emergency contraceptive pills. If a woman wants to terminate an unwanted pregnancy at an early stage, she can use mifepristone.

1 Population Council. Mifepristone, At Last. Momentum. (Jan 2001). http://www.popcouncil.org/publications/momentum/momentum1200_1.html

2 Jones R, Henshaw, S. Mifepristone for Early Medical Abortion: Experiences in France , Great Britain and Sweden . Perspectives on Sexual and Reproductive Health (May/June 2002), citing Cameron et al., Impact of the Introduction of New Medical Methods on Therapeutic Abortions at the Royal Infirmary in Edinburgh , British J. of Obstetrics & Gynaecology, 1996 103(12): 1222-1229 and Winikoff B., Acceptability of Medical Abortion in Early Pregnancy, 1995 Family Planning Perspectives 142 -48, 185 (1995).