"More than 600,000 women in Europe have had medical abortions using mifepristone. Between 1994 and 1995, 121 women in Planned Parenthood and other United States health centers participated in clinical trials of mifepristone and misoprostol sponsored by the Population Council. The results, published in the New England Journal of Medicine and the Archives of Family Medicine in 1998, demonstrated mifepristone to be effective in terminating 92 percent of pregnancies up to 49 days in duration. Additionally, 95.7 percent of women in the same clinical trial reported that they would recommend mifepristone to others. Even among women for whom the method failed, 85.9 percent would recommend it to others. The most common side effect reported by women using mifepristone plus prostaglandin for early abortion and similar to those of a spontaneous miscarriage: uterine cramps, bleeding, nausea, and fatigue. Mifepristone is as safe as aspiration abortion; additionally, it is a completely noninvasive procedure and does not require anesthesia" (Planned Parenthood).

According to the FDA, there are some restrictions that physicians must follow in order to use RU 486. RU 486 must be provided by or under the supervision of a physician who meets the following qualifications:

  -   Ability to assess the duration of pregnancy accurately.

  -   Ability to diagnose ectopic pregnancies.

  -   Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through other qualified physicians, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

  -   Has read and understood the prescribing information of Mifeprex.

  -   Must provide each patient with a Medication Guide and must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and Patient Agreement, give her an opportunity to read and discuss both the Medication Guide and the Patient Agreement, and obtain her signature on the Patient Agreement.

  -   Must notify the sponsor or its designate in writing as discussed in the Package Insert under the heading DOSAGE AND ANDMINISTRATION in the event of an ongoing pregnancy, which is not terminated subsequent to the conclusion of the treatment procedure.

  -   Must report any hospitalization, transfusion or other serious events to the sponsor or its designate.

  -   Must record the Mifeprex package serial number in each patient's record.

The labeling for mifepristone emphasizes that most women using RU 486 will experience some side effects, primarily cramping and bleeding. Bleeding and spotting typically last between 9 and 16 days. In about one of 100 women, bleeding can be so heavy that a surgical procedure will be required to stop the bleeding. The drug labeling also warns that it should not be used in women with the following conditions:

  -   Confirmed or suspected ectopic ("tubal") pregnancies.

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  -   Intrauterine device (IUD) in place

  -   Chronic failure of the adrenal glands

  -   Current long-term therapy with corticosteroids

  -   History of allergy to mifepristone, misoprostol, or other prostaglandins

  -   Bleeding disorders or current anticoagulant (blood-thinning) therapy (FDA).

"In the United States trials, 92.1% of the 827 subjects had a complete medical abortion. In 52 women (6.3%) expulsion occurred within two days, and resulted from the action of mifepristone (600 mg) alone, unaided by misoprostol, an analog of prostaglandin. All other women without an apparent expulsion took a 400 ...

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