1. What is MIFEPREX (mifepristone) and how does it
Mifepristone is a drug that blocks a hormone called progesterone that is needed for
pregnancy to continue. Mifepristone, when used together with another medicine called
misoprostol, is used to end an early pregnancy (49 days or less since your last menstrual
2. Is mifepristone approved in any other countries?
Yes, mifepristone has also been approved in the United Kingdom, Sweden and other
3. Who should not take mifepristone?
Some women should not take mifepristone. Do not take mifepristone if it has been more
than 49 days since your last menstrual period or if you have:
- a tubal pregnancy
- an intrauterine device (IUD) in place (It must be removed before you take mifepristone)
- problems with your adrenal glands (the glands near your kidneys)
- been treated with certain steroid medications for a long period of time
- bleeding problems or are taking anticoagulant (blood thinning) drug products
- had an allergic reaction to mifepristone, misoprostol or similar drugs
It is important that you understand the need for 2
follow-up visits with your health care provider and that you have access to a medical care
facility in case of an emergency.
Mifepristone has not been studied in women who are heavy smokers. Please tell your
doctor if you smoke more than 10 cigarettes a day.
4. Is mifepristone distribution restricted?
Yes, mifepristone is supplied directly to doctors who meet certain qualifications. It is not and will
not be available in pharmacies, and it is not legally available over the Internet.
5. Why are there restrictions for this drug?
Studies of mifepristone were conducted by doctors who had certain qualifications. Both
the drug sponsor and the 1996 Reproductive Drug Products Advisory Committee also
recommended that FDA restrict distribution of mifepristone to qualified doctors. FDA has
concluded that these restrictions are necessary for the safe use of the drug.
6. What qualifications must doctors have to obtain mifepristone?
Doctors must have the ability to date pregnancies accurately and to diagnose tubal
pregnancies. Doctors must also be qualified to provide any necessary surgery, or have made
arrangements for any necessary surgery. Doctors must ensure that women have access to
medical facilities for emergency care, and must agree to other responsibilities, such as
dispensing the Medication Guide and reporting any adverse events to the sponsor.
7. What authority does FDA have to restrict distribution of a drug?
The law authorizes FDA to approve new drugs only if they have been demonstrated to be
safe and effective for use under the conditions of use recommended in the label. FDA has
broad authority to require restrictions on distribution to ensure safe and effective use.
FDAs full legal authority to restrict distribution of a drug is described in more
detail in the preamble to agency drug regulations. Federal Register Notice.
8. Can health care providers other than doctors dispense mifepristone?
Some states allow physicians to supervise other health care practitioners, such as
certified registered nurse practitioners and nurse midwives, and these states may allow a
supervised health care provider to dispense mifepristone. Health care providers should
check their state law provisions.
9. Is there an age restriction for termination of pregnancy?
State law determines whether there are any restriction on minors obtaining surgical or
medical abortions. FDA has not set any separate age restriction on the provision of
Mifepristone states may set age restrictions on termination of pregnancy if they believe
such restrictions are appropriate.
10. Are there studies with mifepristone in women under the age of 18?
Studies to evaluate mifepristone included women ages 18-45.
11. What are the possible side effects of using mifepristone?
Mifepristone treatment will cause vaginal bleeding. In some cases vaginal bleeding can
be very heavy. In a few cases, this bleeding will need to be stopped by a surgical
Other possible side effects of the treatment include diarrhea, nausea, vomiting,
headache, dizziness, back pain, and tiredness.
The possible side effects are described in the Medication Guide. Please read the Medication Guide.
12. What is a Medication Guide?
A Medication Guide is a leaflet that contains certain FDA-approved information, written
especially for patients.
13. Why did FDA develop a Medication Guide for mifepristone?
FDA determined that a Medication Guide was necessary for women to be able to use
mifepristone effectively and safely. It is important for women to be fully informed about
how mifepristone works and about its risks, as well as the need for follow-up visits with
their health care provider, especially on the 14th day after mifepristone is administered.
The Medication Guide will help ensure that women follow the directions for use and that
they return to their health care provider for follow-up visits.
Before you receive mifepristone, your doctor will provide you with the Medication Guide
and ask you to sign a statement (Patient Agreement) that you have decided to end your
14. Can I become pregnant again if I take mifepristone?
You can become pregnant again right after your pregnancy ends. If you do not want to
get become pregnant again, start using a birth control method of your choice as soon as
your pregnancy ends.
15. Does FDA endorse the use of this drug?
FDA does not endorse or promote any drug product. The agency evaluates all drug
applications submitted by sponsors to determine whether a drug is safe and effective for
its proposed indication under the conditions of use in the labeling. This means that the
benefits of the drug outweigh its risks. The same standards were applied to the new drug
application for mifepristone as are applied to all applications.
16. How much will mifepristone cost?
Manufacturers establish prices for prescription drugs. FDA has no input into or
jurisdiction over drug pricing. FDA does not know what mifepristone will cost when it
17. Will insurance companies pay for mifepristone?
The FDA has no input into or legal control over whether an insurance company does or
does not cover the cost of a drug. Insurance coverage is a decision made by your insurance
provider. Please call your insurance company if you have questions, about whether your
particular insurance provider will cover the cost of mifepristone.