Early Abortion Pill Approved by FDA
More than 600,000 women have used the pill in Europe. It has been available for more than a decade in France, and more recently in Britain, Sweden, and other countries. More than 2,000 women have taken the medication in the U.S. as part of its clinical testing.
While the pill may provide women greater privacy and eliminate the need for surgery and anesthesia through a standard abortion, taking it is a somewhat involved process. A woman must first take Mifeprex in an initial session with a doctor that includes signing a detailed patient consent form. Two days later, she must return to the office or clinic; if she is still pregnant, she must take a second pill, the FDA-approved misoprostol, which causes contractions in the uterus. That drug forces the early embryo and the lining from the womb.
Two weeks after her initial doctor visit, a woman must again return to confirm that the medications succeeded in ending the pregnancy. The combination of the two drugs is about 92-95% effective in ending an early pregnancy, Danco said.
Mifeprex is separate from the FDA-approved "morning after" pill, which women can use to prevent pregnancies up to 72 hours after unprotected sex. According to Danco, "Mifeprex can be taken between the time a woman knows she is pregnant and up to 49 days after the beginning of her last menstrual period."
The drug does have side effects -- largely bleeding and cramping. The FDA warns that bleeding may occur for 9-16 days. The agency cautions that in about 1 of 100 women, bleeding can be heavy enough to require a surgical procedure known as curettage.
FDA is limiting the physicians who may prescribe Mifeprex. The agency says that doctors who prescribe the drug must be able to date pregnancies accurately. They must also be able to diagnose tubal pregnancies, since women with tubal pregnancies may not take the drug.
FDA also requires that physicians be prepared to provide women any necessary surgery, or arrange for those procedures in the case of incomplete abortion or severe bleeding. Doctors also must ensure that women who take the drug have access to emergency care.
The agency first issued an "approvable" letter for the drug in 1996, which indicated that most -- but not all -- conditions for approval had been met.
But since then, the drug has had a tough time finding its way to market. Congress has repeatedly tried to block FDA's review of the drug, even as ownership of the rights to the medication changed hands. In 1989, the Bush Administration had banned Americans from importing RU-486 for personal use, a ban that Clinton lifted in 1993.
"Today's action by the FDA assures that women across the country will be able to make informed choices about the use of this drug -- choices based on solid scientific evidence," said Richard G. Roberts, MD, president of the American Academy of Family Physicians.