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Article Excerpt
In September 2000, the U.S. Food and Drug Administration approved mifepristone, the drug also known as RU-486, for medical (non-invasive) early abortion. Mifepristone works by blocking the hormone progesterone, which is needed for a pregnancy to continue. When used in conjunction with another drug, misoprostol, the method is effective for ending unwanted pregnancy between 92 and 98 percent of the time.
The FDA-approved treatment regimen for mifepristone brand name Mifeprex[R] --is for use up to 49 days after a woman's last menstrual period. Once pregnancy is confirmed, the woman takes 600 mg of mifepristone orally. Two days later, she takes 400 micrograms of misoprostol, which stimulates uterine contractions to expel the pregnancy. She is required to return for a follow-up visit approximately 14 days after taking mifepristone to confirm that the pregnancy has been terminated. More recent studies have shown the safety and efficacy of modified regimens, including lower doses of mifepristone, administering misoprostol one, two or three days after mifepristone, and administering misoprostol at home.
I recently spoke with Dr. Elizabeth Newhall, an obstetrician-gynecologist in Portland, Oregon. She is the medical director at Downtown Women's Center, a 25-year-old abortion clinic, as well as a private practice ob-gyn at Everywoman's Health, P.C. Dr. Newhall began providing medical abortions in 1994 while serving as co-principal investigator for the Population Council's clinical trials on mifepristone. She was a key presenter to the FDA at its advisory committee meeting in July 1996.
Arielle Lutwick: Dr. Newhall, how long have you been providing medical abortion?
Elizabeth Newhall: I began work on mifepristone medical abortion in 1994 in my practice at the Downtown Women's Center as part of the clinical trials conducted by the Population Council. About 200 women participated in the initial study. Later, I worked on research protocols exploring simplified regimens and ways to expand access to the method.
AL: Do you continue to use the same protocol as was used in the clinical trials?
EN: No. The FDA-approved protocol was already outdated by the time mifepristone was approved in 2000. During the clinical trials, patients had...
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