GET THE FACTS: RU-486
What are the differences between Emergency Contraception and RU-486?
I've heard so many terms for the RU-486. What are the common names?
What is Mifepristone?
Where can you get Mifepristone?
Access and Mifepristone
When can you use Mifepristone?
How do you use Mifepristone?
What are the possible side effects?
How effective is it?
How safe is Mifepristone?
Why you would or would not chose Mifepristone?
How much does Mifepristone cost?
What are the FDA requirements for Mifepristone?

September 28, 2000 marked a monumental advancement for women's reproductive health and rights in the United States. Over a decade of debate in America came to a screeching halt when the Food and Drug Administration (FDA) approved Mifepristone (pronounced miff-a-PRIS-tone), otherwise known as RU-486 and the 'abortion' pill, for the termination of early first trimester pregnancies.

But the fight may not be over. President George W. Bush has not been shy about his agenda around issues of abortion - and to underscore his anti-choice sentiment he has declared that his administration will not only review the 'abortion' pill's approval but hopes to limit the number of doctors who can prescribe it.

Mifepristone is an antiprogesterone drug that blocks receptors of progesterone, a key hormone in the establishment and maintenance of pregnancy. Used in combination with a prostaglandin such as misoprostol, Mifepristone induces abortion when administered in early pregnancy, providing women with an alternative to surgical abortion.

The availability and accessibility of RU-486 in the U.S. marks a leap forward in reproductive technology and health that saves and benefits women's lives. Roughly 20 million surgical abortions are performed under unsafe conditions and 80,000 women die from complications per year globally. Access to RU-486 offers women an early, highly effective, private and non-invasive option.

What are the differences between Emergency Contraception and RU-486?

	EMERGENCY CONTRACEPTION PILLS (ECP's)	RU-486/MIFEPRISTONE
Function	PREVENTS a pregnancy after intercourse	Terminates a pregnancy
Time Frame	Effective if taken within 72 hours of unprotected intercourse	Approved by FDA to terminate pregnancies of up to seven weeks in duration
Brand Name	Preven or Plan B	Mifeprex
Contents	Consists of high dose birth control pills	Consists of the drup Mifepristone, which is taken in combination with another drug, misoprostol
FDA Safety Ruling	FDA approved as safe and effective for pregnancy prevention after intercourse	FDA approved as safe and effective for pregnancy termination
AMA Resolution	The AMA passed a resolution and women's groups have joined in calling for ECP's to be available for over the counter use	No resolution calling for over the counter distribution of Mifepristone or other abortion-inducing drug

I've heard so many terms for the 'abortion' pill. What are the common names?
Mifepristone (pronounced miff-a-PRIS-tone) - generic name
Mifeprex - Name that was trademarked for sale in the U.S.
RU-486

What is Mifepristone?
Mifepristone blocks a hormone that is needed for a pregnancy to continue. It is an early option to terminate a pregnancy nonsurgically. Mifepristone is used in combination with another medication called misoprostol, which causes the uterus to cramp and expel the embryo.

Where can you get Mifepristone?
You must get Mifepristone from a doctor's office or a medical clinic. Mifepristone cannot be dispensed through drugstore pharmacies.

How can Mifepristone can improve access?
The approval of Mifepristone should make early abortion more accessible by increasing the number of providers and allowing women to obtain an abortion without facing clinic protesters. The violence, threats, and harassment targeted at women and doctors by anti-choice activists have intimidated women from having surgical abortions and prevented many medical practitioners from providing abortion. Eighty-six percent of counties in the U.S. have no identified abortion provider. Mifepristone could help solve this problem - many doctors who are not willing to perform surgical abortions have said that they would prescribe Mifepristone for medical abortion.

When can you use Mifepristone?
Under the FDA regimen, Mifepristone can only be used 49 days (7 weeks) or less since the first day of the last menstrual period. Many women discover they are pregnant after missing their first period, which is already at least four weeks after the first day of their last menstrual period. Therefore, there is only a short window of three weeks from the time that a woman misses a period that she can use Mifepristone to terminate a pregnancy.

How do you use Mifepristone?
The FDA requires three visits with a provider to complete the administration of Mifepristone to be sure that you are no longer pregnant.

On day 1: At the provider's office, you have a physical exam confirming pregnancy, be given a Medication Guide to read, and need to sign a Patient Agreement stating that you understand the information given to you. Afterwards, you will take Mifepristone.

On day 3: You return to the provider's office. The provider will check to see if you are still pregnant. If you are, you swallow misoprostol tablets.

On day 14: You return to the provider's office. The provider will check to make sure you are not pregnant. If, in the unusual circumstance you are still pregnant, the provider will discuss other choices, including a surgical abortion.

What are the possible side effects?
As with most medications, Mifepristone may have some expected side effects. Just like a miscarriage, Mifepristone can cause cramping and bleeding. The bleeding may be similar to a heavy period, but could be greater. Also like a miscarriage, Mifepristone may cause diarrhea, nausea, and other symptoms. Your provider will work with you to help manage any side effects, including giving you appropriate medicine.

How effective is it in ending pregnancy?
Studies indicate that Mifepristone is effective in ending pregnancy about 92 to 96 percent of the time. If the abortion is incomplete, women will talk with their providers about choices, including a surgical abortion to ensure that the abortion is complete.

How safe is Mifepristone?
Mifepristone has been used safely and effectively in other countries since 1981. More than 600,000 women in Europe have used Mifepristone for pregnancy termination and it is available to women in Austria, Belgium, China, Denmark, Finland, France, Germany, Greece, Israel, Luxemburg, the Netherlands, Norway, Russia, Spain, Sweden, Switzerland, Ukraine, and the United Kingdom.

Why you would or would not chose Mifepristone?
To some women, using Mifepristone feels more natural and gives them a sense of control over the abortion process. Patient satisfaction rates are very high. According to a recent study, 96 percent of women who have used Mifepristone would recommend the method to others.

Women who have the following conditions should not take Mifepristone:
A tubal pregnancy
An intrauterine device (IUD) in place (it must be removed before taking Mifepristone)
Problems with adrenal glands
Been treated with certain steroid medications for a long time
Bleeding problems or are taking anticoagulant (blood thinning) products; or
Had an allergic reaction to Mifeprex, misoprostol, or similar drugs.

How much does Mifepristone cost?
An abortion through the use of Mifepristone is expected to cost about the same as a first trimester surgical abortion, which can range from approximately $200-$400. Some insurance providers cover medical abortions.

What are the FDA requirements for Mifepristone?
The FDA requires that Mifepristone be provided by or under the supervision of a physician who: has the ability to assess the duration of pregnancy accurately; has the ability to diagnose ectopic pregnancies; has the ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, OR has made plans to provide such care through other qualified physicians; is able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary; and has read and understood the drug's prescribing information and signed the Prescriber's Agreement.

The FDA requires that the provider must: fully explain the procedure to each patient; give the patient a Medication Guide, which is written patient information about Mifepristone; give the patient a Patient Agreement, which is to be signed by both the patient and the provider; and give the patient an opportunity to read and discuss both the Medication Guide and the Patient Agreement.

The FDA requires three visits to the Provider: First visit (day one): The patient is given a physical exam confirming pregnancy, counseled about the process, given the Medication Guide, and asked to sign the Patient Agreement. Afterwards, the patient will take Mifepristone. Second visit two days later (day three): The provider will check to see if the patient is still pregnant. If she is, she will take misoprostol tablets. Third visit about 12 days later (day fourteen): The provider will check to see that the pregnancy has ended. If it has not, the provider will discuss other choices, including a surgical abortion.

Recognizing that Mifepristone is safe and effective, the FDA DID NOT require certain restrictions supported by anti-choice activists, such as the following: