Abortion pill heading to U.S. clinics as early as today

ATLANTA, Georgia (CNN) -- Amid protest and praise, the first shipments of the abortion pill, commonly known as RU-486, were expected to become available to women in the United States today.

Danco Laboratories, which markets the pill, began shipping it Monday under the name Mifeprex. A Danco spokeswoman told CNN the company has received a large number of advance orders and information requests for the drug, the subject of years of legal and ethical debate.

Authorities caution the pill likely will not create an immediate, sweeping change in clinical procedures. Private doctors so far are slow to embrace it, and it can take several days for the drug to take effect.

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The pill, whose manufacturer remains a secret, also only works in early pregnancy, a caveat about which some women may be unaware.

"A woman might feel that all she has to do is take a pill and the pregnancy kind of magically disappears, and of course that's not true," said Dr. Maureen Paul of the Planned Parenthood League of Massachusetts in Boston.

The U.S. Food and Drug Administration gave final approval for the pill in September.

Planned Parenthood said shipments of Mifeprex were being sent to about 60 centers in 16 states. Staff members have undergone training to offer the early abortion option.

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.

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U.S. Food and Drug Administration
Early Option Pill
Planned Parenthood
National Right to Life Committee

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