United States of America - The Food and Drug Administration has approved mifepristone (Mifeprix®) for the termination of early pregnancy, defined as 49 days or less from the beginning of the last menstrual period.
Under the approved treatment regimen, 600 mg of mifepristone is followed two days later with 400 micrograms of misoprostol, a prostaglandin. A follow-up visit should be scheduled 14 days after administration to determine whether pregnancy has been terminated.
A medication guide will be provided to each woman receiving mifepristone explaining how to take the drug, when to avoid taking it and possible side effects.
Mifepristone should not be used on women with the following conditions:
• Confirmed or suspected ectopic pregnancy.
• Intrauterine device (IUD) in place.
• Chronic failure of the adrenal glands.
• History of allergy to mifepristone, misoprostol or other prostaglandins.
• Bleeding disorders or current anticoagulant therapy.
Physicians allowed to administer mifepristone must be part of a national registry and must be qualified to perform surgical intervention in cases of incomplete abortion or severe bleeding, or they must have made plans in advance to provide such care through others.
Mifepristone was first approved for use in France in 1988. Since then 620 000 European women have taken mifepristone in combination with a prostaglandin to terminate pregnancy.
Reference: HHS News, P00-19 (2000).