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04 October 2000

Women's Health Advocates Salute RU-486 Approval

UCSF researchers and women's health advocates are hailing the recent decision by the Food and Drug Administration to grant American women access to another option for early abortion RU-486 or mifepristone.

After 12 years of waiting while European women had access to non-surgical abortion, American women will be able to use the drug, which has proven to be a safe, effective, acceptable option for women seeking early abortion.

The FDA on Sept. 28 gave final marketing approval for the sale and distribution of mifepristone in the United States. Since its approval in France in 1988, the drug has been available to women in Britain, Sweden, China and other countries.

"This is a milestone for the health of American women," says Felicia Stewart, MD, co-director of the Center for Reproductive Health Research and Policy (CRHRP) at UCSF and board member of the National Abortion Federation. "We have waited too long for access to this technology. More than 12 million American women have been denied the potential health benefits of an option that women in over 20 countries have used safely for over 12 years."

Alisa Goldberg, MD, medical director of the Women's Options Center at San Francisco General Hospital and a NIH Women's Reproductive Health Research Scholar, called the FDA announcement "great news." She and other women's health advocates are glad that women have another choice in their reproductive lives.

What will this mean to women? Women who want to consider improved options for very early abortion will need to act early. "Don't delay in scheduling a pregnancy test and exam for accurate diagnosis and dating, " Stewart advises. "This (mifepristone) option is only possible during the first two or three weeks after a woman misses her period."

The approval of mifepristone has the potential to increase access to abortion services for women across the country. Over the last two decades access to safe abortion has continued to decline for American women, researchers say. Violence, vandalism and intimidation at abortion clinics across the US have taken a toll on physicians and patients alike.

"More than 86 percent of the counties in the United States have no surgical abortion provider and abortion is not routinely taught in medical schools or residency programs," says Uta Landy, PhD, program director of The Kenneth J. Ryan Residency Training Program in Abortion and Family Planning.

"Access to mifepristone has the potential to increase the number of providers who offer abortion services," says Landy, referring to the results of a recent study by the Kaiser Family Foundation evaluating the willingness of non-abortion providers to offer mifepristone when it becomes available.

Mifepristone will only be distributed to doctors who can operate in case a surgical procedure is needed or to doctors who have arrangements with someone who can. Physicians must also be trained to diagnose ectopic or tubal pregnancies because these women cannot be treated with mifepristone.

"We are excited about the increase in options for women, but surgical abortion will always need to be a component of women's healthcare and a routine part of medical training," says Landy.

Surgical abortions will continue to be the preferred choice for some women and will remain the backup for those women with incomplete abortions and for those needing abortion after the ninth week of pregnancy.

Another alternative

"Surgical abortion is already one of the safest medical procedures and now women have access to another safe and effective option for early abortion," says Philip Darney, MD, professor, UCSF department of obstetrics, gynecology and reproductive sciences and a lifelong advocate of safe abortion alternatives.

Frustrated by the political battle over the ban on importing RU-486, Darney, who is also chief of service at SFGHMC and CO-director of the CRHRP, in 1989 began to work with colleagues to find an alternative method for non-surgical abortion. Their protocol for the use of methotrexate and a second drug called misoprostol (also known as cytotec) has been thoroughly studied and is currently available in the US although not widely utilized.

In fact, because it has taken so long in the approval process, the drug regime approved for use by the FDA is based on data from the original studies conducted by the Population Council over a decade ago. "Since that time we have refined and improved the protocols for safe and convenient use by women," says Goldberg.

"One of those improvements is in the use of misoprostol by women," says Cynthia Harper, PhD, demographer at the CRHRP who recently completed a study looking at the need for administering the medications in a clinic setting. As always, providers are guided by accepted medical standards when determining medication use. "Other options for administration of misoprostol are evidence-based approaches to improving abortion services for women," says Harper.

Mifepristone is a synthetic steroid that blocks progesterone receptors, which are necessary to establish and sustain pregnancy, explains Karen Meckstroth, MD, family planning fellow in the UCSF department of obstetrics, gynecology and reproductive sciences at SFGHMC. After a woman takes an oral dose of mifepristone, she waits 48 hours to insert four tablets of misoprostol (also known as cytotec) into her vagina. This induces uterine contractions, which expel the gestational sac from the uterine cavity. Treatment then results in cramping and bleeding similar to an early miscarriage or heavy menstrual cycle and is 92 to 98 percent successful through the seventh week of pregnancy, Meckstroth says.

In addition to increased privacy, the advantage of using mifepristone in conjunction with misoprostol is that women can avoid surgery and anesthesia, she explains. The drug combination can be prescribed as soon as a woman knows she is pregnant and works into the seventh week of pregnancy. Surgical methods most often require waiting until the sixth week of pregnancy. Treatment with methotrexate-misoprostol, the other non-surgical option, requires more visits to the doctor and a less predictable time before the abortion is complete.

While surgical procedures take 15 minutes to complete and are more than 98 percent effective, mifepristone abortions take longer and are slightly less effective. By day seven following the ingestion of the mifepristone, about 95 percent of women have had a complete abortion, says Meckstroth.

The FDA mandated that women be given information brochures to explain who is eligible for a medical abortion and the potential for side effects. The FDA also requires that women make three trips to the doctor's office to complete the mifepristone procedure.

Mifepristone will be called the "early option pill" in the United States, although it should not be confused with emergency contraception, called the "morning-after pill." Emergency contraception regimens are high doses of birth control pills or progestins that prevent the release of eggs from the ovaries or implantation into the uterus. Once pregnancy implantation has occurred, these emergency contraception regimens are no longer effective.

By contrast, mifepristone, used in conjunction with misoprostol, works after the fertilized egg has implanted in the uterus, explains Meckstroth. While there have been studies of mifepristone also as a morning-after pill, the only approved use of mifepristone is to terminate a confirmed pregnancy.

"It is not enough for American women to have this drug," says Tracy Weitz, MPA, project director for the CRHRP. "Women around the world will continue to be denied access to this option either because of politics or lack of resources."

UCSF researchers Darney and Meckstroth are conducting clinical trials to study the effectiveness of misoprostol alone (without mifepristone or methotrexate) to induce medical abortions. "Because misoprostol is widely available as an anti-ulcer medication, inexpensive, stable without refrigeration in tropical climates, easy to transport and simple to administer, the regimen that uses misoprostol alone could greatly improve the access to safe medial abortion services by women in developing countries," explains Meckstroth.

Danco Laboratories, LLC, is licensed to manufacture, market, and distribute mifepristone in the US.

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