Early Abortion Pill Approved by FDA
The National Right-to-Life Committee expressed outrage over a published report -- from earlier this month in the Wall Street Journal -- that the drug would be manufactured in China, where the government mandates some abortions. Danco won't say where the drug is being manufactured.
"It's a very safe, very effective medication," Vicki Breitbart, EdD, MSW, associate vice president for clinical services and director of the clinician training initiative at Planned Parenthood in New York City, tells WebMD. "Mifepristone ... has been used by millions of women around the world, so we have a lot of information with respect to safety and efficacy."
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.