Questions and Answers about Mifepristone - 9/28/2000
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1. What is MIFEPREX (mifepristone) and how does it work?
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 period began).
2. Is mifepristone approved in any other countries?
Yes, mifepristone has also been approved in the United Kingdom, Sweden and other countries.
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. FDA’s 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 procedure.
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 pregnancy.
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 becomes available.
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.