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Abortion pill available to U.S. women as soon as Tuesday
ATLANTA (CNN) -- After years of legal and ethical debate, Danco Laboratories began shipping orders of the abortion pill Mifeprex, more commonly known as RU-486, to U.S. facilities Monday.
A Danco spokeswoman told CNN on Monday that women in the United States will have this option "as early as tomorrow." She added that the company has received a very large number of orders and information requests.
Planned Parenthood said shipments of Mifeprex "will be received throughout the week in about 16 states, at approximately 60 centers." The staff at all of the centers that will receive shipments have completed the required training needed in order to offer this early abortion option.
The U.S. Food and Drug Administration gave final approval for the abortion pill in September. Danco Laboratories is marketing the drug but the manufacturer remains a secret.
The treatment involves three visits to a doctor or clinic. Following a physical exam, pregnancy test and ultrasound exam to date the pregnancy, the woman is given three Mifeprex tablets to take in the office. Within two days, the woman returns to the doctor's office and takes two tablets of misoprostol, an FDA-approved drug to treat ulcers.
Mifeprex blocks the hormone progesterone that's needed for a pregnancy to continue. Misoprostol causes the uterus to contract and expel the fetus. Six hours following the dose of misoprostol, most women will complete the abortion.
Bleeding or spotting can last an average of nine to 16 days. The woman returns to the doctor a third time about 12 days after getting the drugs to be sure the pregnancy has ended. Mifeprex, known generically as mifepristone is provided directly to doctors' offices or clinics and will not be available through pharmacies.
Studies published in the New England Journal of Medicine and Archives of Family Medicine in 1998 show the pill is 92 percent effective in terminating pregnancies up to 49 days in duration, or within the first seven weeks of pregnancy. If the procedure fails, the woman has a surgical abortion.
Ninety-five percent of the women in the U.S. studies of the drug said they would recommend the pill regimen to others. Among the women in which the treatment failed, 86 percent said they would still recommend it to others.
The side effects of the early abortion procedure are similar to those of a spontaneous miscarriage: uterine cramping, bleeding, nausea and fatigue.
"Mifepristone gives women another option. Many women prefer it because they feel it's a more natural option compared to surgical abortion," Gloria Feldt of Planned Parenthood said. "But that's not true for all women. In France for example, about half the women choose the pill and the other half choose to have a surgical procedure."
The European version of the pill, RU-486, was first approved for use in September, 1988, in France. The drug was developed by the pharmaceutical firm Roussel-Uclaf. In 1991 RU-486 was approved for use in Britain and in 1992 it was approved for use in Sweden.
It is estimated that approximately 500,000 women in Europe have had medical abortions using the pill.
Roussel-Uclaf would not market the drug in the United States or any other country where the company perceived that political and social conditions were unreceptive. In 1994 the drug maker donated the U.S. patent rights for mifepristone to the Population Council, a New York-based nonprofit research institution.
In 1996 the FDA gave the drug conditional approval, indicating it was safe and effective.
The Population Council granted Danco Laboratories, a new women's health pharmaceutical company, a license to manufacture, market and distribute the drug. After one manufacturer backed out of the project, Danco identified manufacturers willing to produce mifepristone. The identity of the manufacturers has not been released.
Food and Drug Administration approves abortion pill
U.S. Food and Drug Administration
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