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Mifepristone, brand name Mifeprex, is also widely known as the "abortion pill" or RU486. It is a form of medical/medication abortion.

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 are safely offered in a variety of settings, women experience a greater degree of privacy and control over the process of terminating an unwanted pregnancy.

Frequently Asked Questions about mifepristone

What is 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 would a woman choose to use mifepristone to terminate a pregnancy?

What are the side effects of taking mifepristone?

Who should not use mifepristone?

Who can prescribe Mifeprex in the United States?

What does Mifeprex look like?

Will insurance cover the use of Mifeprex? What does it cost?

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

Was the Food and Drug Administration’s (FDA) approval of Mifeprex adequate for the US Market? Has there been adequate oversight of the drug since approval?

Don't see your question here? Let us know.

What is mifepristone? How does mifepristone work?
Mifepristone is a pill that terminates an early pregnancy.  The U.S. Food and Drug Administration (FDA) approved mifepristone for use within 49 days from the start of a woman’s last menstrual period.   Evidence suggests it may be used safely up to 63 days or 9 weeks after the first day of a woman’s last period.[1]  Mifepristone ends a pregnancy by blocking the receptors of the hormone progesterone, causing the lining of the uterine walls to shed similar to during one’s menstrual cycle.[2]  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 97% of the time.[3] In the instance mifepristone does not work, as determined by an ultrasound during a follow up visit, a woman will need to have a surgical abortion.

VIDEO: Planned Parenthood, What is the Abortion Pill? click: here 

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How does a woman take mifepristone to terminate a pregnancy?
Under the FDA approved regimen for Mifeprex (mifepristone) the following three steps are taken:[4]

Step One: A woman first takes 600 mg of mifepristone (three 200-mg pills by mouth) given to her by her medical provider.  This first administration typically occurs her doctor’s office, a hospital, or a clinic.  All women should be offered analgesics for pain management.  The risk of infection following a medical abortion is low, therefore use of antibiotics as part of the medical abortion regimen are not necessary.[5]   

Step Two: A woman takes 400 micrograms (two 200 microgram pills) of misoprostol up to two days later. She and her medical provider will plan the location and timing of this dose, including administering it at home.  It is recommended to wear a sanitary napkin at this time to help a woman keep track of her bleeding. Bleeding is usually the heaviest 4-6 hours after taking misoprostol. For more information on misoprostol click: here

Step Three: Approximately 14 days after taking the mifepristone, a woman will return to her healthcare provider for a follow-up visit, to determine with an ultrasound whether the pregnancy has been terminated. A woman may also experience light bleeding or spotting for up to four weeks after taking mifepristone and misoprostol.

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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 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 to extend the use of medical abortion up to 63 days gestation.  Misoprostol may be ingested orally, dissolved between the cheek and gum, or placed into the vagina.  Additionally, extensive clinical data support the safety and efficacy of administration of misoprostol at home.

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What would a woman choose to use mifepristone to terminate a pregnancy? [6]
Medical abortion is noninvasive and more private than surgical abortion. In fact, studies reveal that nearly all women who have used mifepristone would recommend it to a friend.

  • Mifepristone carries no risk of uterine perforation (a hole in the wall of the uterus),
  • Complications caused by anesthesia and risk of infection are even rarer than in other abortion procedures.

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What are the side effects of taking mifepristone? [7]
All women who use mifepristone experience bleeding and cramping; both symptoms are normal and part of the medical abortion process.

Other potential and normal side effects include nausea, headache, vomiting, diarrhea, dizziness, back pain, tiredness, mild fever and/or chills. These side effects lessen by the third day after taking mifepristone and are usually gone within two weeks. Serious adverse events, like hospitalization or blood transfusions, are extremely rare.

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Who should not use mifepristone?
Mifepristone should not be used if a woman: [8]

  • is more than 63 days, or nine weeks, pregnant.
  • currently has an IUD. She will need to have it removed before having a medication abortion.
  • has an ectopic pregnancy (one outside of the uterus, usually in the fallopian tubes)
  • has a molar pregnancy (one in which the placenta develops abnormally).
  • has severe adrenal gland, heart, kidney, or liver problems.
  • has a history of allergy to mifepristone or other prostaglandins.
  • has been diagnosed with a bleeding disorders or is undergoing blood-thinning therapy.
  • is not willing to have a surgical abortion in the unlikely case that the medicines do not end her pregnancy.
  • cannot come to follow-up appointments.
  • does not have access to a telephone, transportation, and backup medical care.

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Who can prescribe Mifeprex in the United States?
Mifeprex (mifepristone) is only available to qualified health care professionals who can do all of the following: [9]

  • establish an account with Danco Laboratories, the manufacturer of the drug (www.earlyoptionpill.com),
  • assess the duration of the pregnancy accurately,
  • diagnose ectopic or molar pregnancies and
  • provide surgical intervention or plan intervention at other medical families in cases of incomplete abortion or severe bleeding.

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What does Mifeprex look like?

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Will insurance cover the use of mifepristone for medical abortion? What does it cost?
Many of the nation's largest private health insurers routinely cover Mifeprex. State insurance coverage for Mifeprex varies from state to state. If a woman’s insurance does not cover Mifeprex or she does not have insurance, the cost typically ranges from $300-$800. [10] The cost will also depend on any additional tests, visits, medications or exams that may be needed.

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How does mifepristone differ from emergency contraception or the "morning after pill"? [11]
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

For more information on emergency contraception/“morning after pill” click: here

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Was the Food and Drug Administration’s (FDA) approval of Mifeprex adequate for the US Market? Has there been adequate oversight of the drug since approval?

In August 2008, the Government Accountability Office (GAO) released a report on the FDA’s approval and oversight of the drug Mifeprex.  The study found that FDA actions to allow Mifeprex on the market were consistent with those for other drugs and that post-market oversight has also been consistent with the oversight of the other Subpart H restricted (accelerated approval) drugs.  The FDA continues to monitor adverse events associated with Mifeprex and reviews adverse event and manufacturer compliance reports annually.

For the complete GAO report, go to: http://www.gao.gov/new.items/d08751.pdf.

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[1] Planned Parenthood. (2012). The Abortion Pill (Medication Abortion). Retrieved June 13, 2012, from http://www.plannedparenthood.org/.

[2] UCSF Medical Center. (2012). Medical Abortion. Retrieved June 13, 2012, from http://www.ucsfhealth.org/treatments/medical_abortion/index.html.

[3]Planned Parenthood. (2012). The Abortion Pill (Medication Abortion). Retrieved June 13, 2012, from http://www.plannedparenthood.org/

[4]US Food and Drug Administration. (2011). Mifeprex Information. Retrieved June 13, 2012, from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm.

[5]World Health Organization. (2012).  Safe abortion: technical and policy guidance for health systems.  Retrieved June 13, 2012, from http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf

[6] Planned Parenthood. (2012). The Abortion Pill (Medication Abortion). Retrieved June 13, 2012, from http://www.plannedparenthood.org/

[7] US Food and Drug Administration. (2009). Medication Guide- Mifeprex. Retrieved June 8, 2012, from http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf

[8] Ibid.

[9] Ibid.

[10] Planned Parenthood. (2012). The Abortion Pill (Medication Abortion). Retrieved June 13, 2012, from http://www.plannedparenthood.org/.

[11] UCSF Medical Center. (2012). Medical Abortion. Retrieved June 13, 2012, from http://www.ucsfhealth.org/treatments/medical_abortion/index.html.

 
Resources
Mifepristone Infographic
Factsheet: 13 Years After Mifepristone Was Approved, Legislative Attacks Limit Women's Access to Medication Abortion
GAO Report on Approval and Oversight of Mifeprex
January 30th New York Times article on Mifepristone
Dr. Wood Testifies at House Hearing on RU-486
[PDF, 27KB]
RHTP and Coalition Partners Comment on Medical Abortion Safety to CDC on May 11
[PDF, 257KB]

April 10th UPDATE - Frequently Asked Questions about Fatal Infection and Mifepristone Medical Abortion [PDF, 151KB]

Medication Abortion website
This site is designed to provide accurate information about medication abortion to health service providers including physicians, nurse practitioners, physician assistants, counselors, and office staff.
Danco Laboratories
Manufacturer of Mifeprex (mifepristone)
 
 
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