P00-19 FOOD AND DRUG ADMINISTRATION
September 28, 2000 Print Media: 301-827-6250
FOR IMMEDIATE RELEASE
Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration today approved mifepristone (trade name Mifeprex) for the termination of early pregnancy, defined as 49 days or less, counting from the beginning of the last menstrual period.
Under the approved treatment regimen, a woman first takes 600 milligrams of mifepristone (three 200 milligram pills) by mouth. Two days later, she takes 400 micrograms (two 200-microgram pills) of misoprostol, a prostaglandin. Women will return for a follow-up visit approximately 14 days after taking mifepristone to determine whether the pregnancy has been terminated.
Because of the importance of adhering to this treatment regimen, each woman receiving mifepristone will be given a Medication Guide that clearly explains how to take the drug, who should avoid taking it, and what side effects can occur.
"The approval of mifepristone is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug," said Jane E. Henney, M.D., Commissioner of Food and Drugs. "The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency."
FDA based its approval of mifepristone on data from clinical trials in the United States and France.
The labeling for mifepristone emphasizes that most women using the product will experience some side effects, primarily cramping and bleeding. Bleeding and spotting typically last for between 9 and 16 days. In about one of 100 women, bleeding can be so heavy that a surgical procedure will be required to stop the bleeding.
The drug's labeling also warns that it should not be used in women with the following conditions:
Under the terms of the approval, mifepristone will be distributed to physicians who can accurately determine the duration of a patient's pregnancy and detect an ectopic (or tubal) pregnancy. Physicians who prescribe mifepristone must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding--or they must have made plans in advance to provide such care through others.
To gather additional data about the use of mifepristone, the Population Council (sponsor of the product) has made a commitment to conduct postmarketing studies. These include a study comparing patient outcomes among physicians who refer their patients needing surgical intervention, compared to those who perform surgical procedures themselves; an audit of prescribers that will examine whether patients and their physicians are signing the patient agreement and placing it in the patient's medical record, as required; and a system for surveillance, reporting and tracking rare ongoing pregnancies after treatment with mifepristone in the U.S.
Mifepristone, which was developed by a French pharmaceutical firm, was first approved for use in France in 1988. Since then, more than 620,000 European women have taken mifepristone in combination with a prostaglandin to terminate pregnancy. The drug has also been approved in the United Kingdom, Sweden, and other countries.
Mifepristone will be distributed in the U.S. by Danco Laboratories, LLC, New York, N.Y.
More detailed information about this product is available on FDA's website at www.fda.gov/cder/drug/infopage/mifepristone/.
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Web page created by Office of Public Affairs 2000-SEP-28.