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CNN's Rhonda Rowland: FDA approves ‘abortion pill’
(CNN) – The Food and Drug Administration (FDA) approved mifepristone September 28 as an alternative to surgical abortion. The "abortion pill," available as RU-486 in Europe for the past ten years, will be available by prescription under the name Mifeprex. Unlike the "morning-after pill," which prevents pregnancy up to 72-hours after unprotected intercourse, mifepristone induces an abortion when used within the first seven weeks of pregnancy.
Rhonda Rowland, CNN medical correspondent, covers breaking medical news and contributes to the weekend program "Your Health."
Chat Moderator: Welcome to the CNN chat room, Rhonda Rowland.
Rhonda Rowland: Thank you for joining us.
Question from Gogirl: Is this a birth control option or an emergency type thing?
Rhonda Rowland: Absolutely not -- there is a lot of confusion. The abortion pill is not the same as the "morning-after pill." With the "morning-after pill," a woman takes a combination of birth control pills a day or two after unprotected sex. She does not know if she is pregnant, so it works as a contraceptive. However, the abortion pill, Mifeprex, is designed to end an established pregnancy in combination with another drug.
Question from Talk2: Rhonda, a report I heard last night said that using the pill is an extremely painful experience and some women have almost bled to death. The report stated that one woman in the test program lost half her blood after the taking the pill.
Rhonda Rowland: Yes, studies including over 2,000 women show that in one percent of women, the bleeding may be severe enough to warrant surgery. Other women are counseled to expect heavy bleeding, cramping, some nausea and fatigue. But most women in the studies say the side effects are tolerable.
Question from Haley-CNN: Will there be a follow-up on patients taking mifepristone to ensure they no longer are pregnant? If so, and they remain pregnant, what happens then?
Rhonda Rowland: Women who choose this option are asked to return to the doctor's office or clinic within 12 days after taking the second drug. This is to ensure that the abortion is complete. In addition, the sponsor of the drug -- which is the Population Council -- has committed to following these women for safety reasons. If there are some pregnancies that do continue, they would follow those to assess the outcome.
Question from Gogirl: Will all doctors be required to have this available, or is it a doctor’s choice?
Rhonda Rowland: This is a physician's choice, just as it is a physician's choice to perform a surgical abortion. Surveys suggest that more physicians would be willing to provide an abortion with Mifeprex than surgical abortion.
Question from Guest68042: What about side effects? Can anyone explain? Does the pharmaceutical company provide enough information on this?
Rhonda Rowland: Part of the FDA approval process was that Danco Laboratories, the company that will market and distribute the drug, will provide doctors with patient guides that women must read before agreeing to the procedure. A woman must sign a statement stating she understands the procedure and the side effects.
Question from Aus: How does the new pill work?
Rhonda Rowland: A woman goes to a doctor's office or a clinic such as Planned Parenthood. She gets a physical exam, a pregnancy test and an ultrasound to date the pregnancy. She must be seven weeks pregnant or less. She takes three Mifeprex tablets. Two days later she returns and takes two misoprostol tablets, and then she returns 12 days later for another exam.
Question from Haley-CNN: There is mifepristone available in a vaginal suppository that can be used up to nine weeks after pregnancy occurs. Will this be offered in the USA, or is it just the pill for now?
Rhonda Rowland: According to Danco Labs, women would be given misoprostol tablets.
Question from Veritas: The drug prostaglandin has to be used with RU-486. There are only two prostaglandins in the United States and neither of them can be used with RU-486. Is that a big problem?
Rhonda Rowland: Once a drug is approved for use by the FDA for a particular purpose, it can be used off-label for other purposes. For instance, misoprostol is FDA approved for the treatment of ulcers only.
Question from Sunny1-CNN: Can you give us an estimate of the cost, including the visits to the doctor, the ultrasound and the two pills?
Rhonda Rowland: It's estimated that it will cost about the same as a surgical abortion, which is about $300.
Chat Moderator: What is the success rate of the pill?
Rhonda Rowland: Studies done in over 2,000 women in the U.S. indicate that it's about 92 to 95 percent effective in causing an abortion. If the medication fails, then a women needs a surgical abortion.
Question from Candyce-CNN: Why will women elect for the pill over surgical abortion procedures? What are the advantages?
Rhonda Rowland: It's a very personal decision. The women who have chosen it say they prefer it because it is more private and more natural than surgery.
Question from Gogirl: What countries have already had this pill, and for how long have they had it?
Rhonda Rowland: It was first approved in France in 1988, followed by Great Britain and Sweden. It's believed that it is also used in China.
Chat Moderator: Is the pill any less traumatic than a surgical abortion?
Rhonda Rowland: Both surgery and an abortion with medication have risks. A surgery is certainly quicker. Here again, it is a personal choice since an abortion with medication can take up to 16 days to complete.
Question from Xochitl: How old do you have to be to take the pill? What is the legal age?
Rhonda Rowland: It depends on state regulation. It varies tremendously around the country. For instance, some require parental consent.
Danco Laboratories says Mifeprex should be available in laboratories and clinics in about a month. Mifeprex will clearly be a very controversial medication, just as abortion is.
The FDA evaluated this drug for safety and effectiveness and approved it on that basis. Having Mifeprex available gives women who choose abortion another option if they want to end their pregnancy early.
Chat Moderator: Thank you for joining us today, Rhonda Rowland.
Rhonda Rowland: Good-bye and thanks for joining us and for your questions.
Rhonda Rowland joined the News/Health Chat via telephone from CNN headquarters in Atlanta, Georgia. CNN.com provided a typist for her. The above is an edited transcript of the chat, which took place on Thursday, September 28, 2000.
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Food and Drug Administration approves 'abortion pill'
U. S. Food and Drug Administration
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