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Food and Drug Administration approves abortion pill
WASHINGTON (CNN) -- The U.S. Food and Drug Administration on Thursday approved the controversial abortion pill mifepristone, known as RU-486 in Europe, for use in the United States.
"The approval of mifepristone is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use ofthis drug," said Dr. Jane Henney, commissioner of food and drugs. "The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency."
President Bill Clinton echoed the sentiment. "I think it ought to be treated as the scientific and medical decision it was and we should respect the fact it was a non-political inquiry and that they took so long to try to make sure they were making a good decision," he said.
The pill, to be marketed under the name Mifeprex, will be available only through physicians. It should be available in about a month.
The pill is far less invasive than a surgical abortion and can be given in a physician's office. The cost for an abortion using mifepristone is expected to be comparable to that of a surgical procedure -- about $300.
A synthetic steroid, mifepristone interferes with a fertilized egg's ability to adhere to the lining of the uterus. To cause abortion, it is used early in pregnancy with another drug, misoprostol, which prompts uterine contractions.
Studies have shown that the drug is 92-95.5 percent effective in causing abortion when used within the first seven weeks of pregnancy. A very small percentage of patients need additional surgery or blood transfusions. For most, the process is over in a few hours -- a week at most. Side effects include uterine cramping, heavy bleeding, nausea and fatigue.
The FDA said bleeding and spotting typically last for about nine to 16 days. It can be so heavy in about one of 100 women, that a surgical procedure would be required to stop the bleeding, the agency said.
In some cases, the drug combination does not terminate the pregnancy and surgery is required to complete the process.
"Obviously, physicians who offer this early option to their patients must be capable of determining the duration of a pregnancy and able to establish the diagnosis of an ectopic pregnancy," said Dr. Richard Hausknecht, marketing director of Danco Laboratories, the company marketing Mifeprex. For those instances when surgery is needed, he added, doctors "must then be able either to perform a surgical procedure themselves or refer patients to a physician who can."
Although European women have been able to use the drug for more than 10 years as a pharmaceutical alternative to surgical abortion during early pregnancy, availability to American women has been delayed by the tense political climate of the abortion debate. Abortion opponents have fought to keep the drug out of the U.S. market.
"Mifepristone, or the early-abortion pill, is as significant a technological advance for women's health as the birth-control pill was 40 years ago," said Gloria Feldt, president of Planned Parenthood Inc. "It will enable them, if they choose to terminate a pregnancy, to do that earlier (and) to do it without surgery. For many women, that is a very positive thing."
Anti-abortion activists oppose the use of mifepristone and misprostol, saying it is misleading to refer to an at least two-week-old embryo as a fertilized egg and that the method poses health consequences to women.
"American women need to know it will take the life of their unborn child, and there is a serious health risk to themselves," Laura Echevarria, a spokeswoman for the National Right to Life Organization, told Reuters.
The organization's Web site says 2 percent of women who used the drug combination experienced such severe bleeding they required surgery, and that "during U.S. trials one woman nearly bled to death."
But Dr. Carolyn Westhoff, a professor of obstetrics and gynecology at Columbia University who conducted some of the clinical trials of mifepristone, said the drug is safe.
"The overall safety of this early option pill is excellent, both in studies here in the U.S. and in clinical use around the world," she said at a news conference announcing the FDA action.
FDA-approved rheumatoid arthritis drug methotrexate also can be used like mifepristone, but it is not used often because it is less effective.
Mifepristone "helps women in the sense that in some cases, they can end their pregnancies much earlier," said Stanley Henshaw of the Alan Guttmacher Institute. "Nowadays, with sensitive pregnancy tests, some women know they're pregnant even before they miss their first period."
Surveys of physicians done in the state of Washington in 1996 and 1997 indicate that slightly more than one quarter of them would be likely to prescribe mifepristone if it became available. Many in that group said they viewed medical abortions as safe, effective and private.
But there are other issues surrounding access as well.
"Right now there are lots of laws in many states that restrict abortion practice," said Dr. Mitchell Creinin of the University of Pittsburgh. "Medical abortion is not going to be any different."
Danco's Hausknecht also said that doctors will have to follow state regulations on abortion if they choose to provide mifepristone to their patients.
In more than a decade, researchers in France have found that the pill has not replaced surgery as the most common method of abortion. It also has not increased the number of abortions.
The Centers for Disease Control and Prevention in Atlanta, Georgia, noted recently that the abortion rate in the United States is now at its lowest level in 20 years.
Mifepristone differs from the "morning-after pill" approved by the U.S. Food and Drug Administration in 1998. Planned Parenthood has described the "morning-after pill" as "emergency contraception (that) can prevent pregnancy up to 72 hours after unprotected intercourse."
FDA approval of abortion pill linked to stringent conditions
U.S. Food and Drug Administration
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