The latter is a true statement; it describes the only fatality that occurred to a European woman taking RU486. However, it does not tell the full story. RU-486 is a safe method to terminate a pregnancy, as long as it is not used on women with any of three contraindications -- a history of:
After extensive use in Europe, one fatality occurred to a woman who should never have been given the pill, because all three contraindications applied to her. In addition, an older form of prostaglandin was injected in her case. This is no longer used in France and elsewhere. Misoprostol is now used in combination with RU486. One death among 500,000 women using RU-486 was used compares very favorably with the fatality rate if the pregnancies had been allowed continued to term. Trials have been conducted in 20 countries, including France, Germany, the Netherlands, Scandinavian countries, the former Soviet Union, Spain, Switzerland, the UK, and the U.S. The U.S. trial was concluded on 2,100 women who had been pregnant fewer than 7 weeks.
One source compared the safety of various alternatives in North America:
After the pills had been available for about four years in the U.S., the Food and Drug Administration reported that three women had died from bacteria infections in the uterus which later spread to their blood supply, leading to sepsis (a.k.a. blood poisoning). By that time, about 360,000 women had use RU-486. This is a fatality rate of 1 death in 120,000, which makes the use of the medication eight times safer than continuing the pregnancy to childbirth in the U.S.. 4
Deaths that may have been related to RU-486:
A U.S. Food and Drug Administration report describes the "side effects and complications arising from the use of RU-486 during the time it has been available in the U.S. Market:" from 1997-NOV to 2001-NOV. Unfortunately, the report lumps together men and women who took the drug, ranging in age from teenagers to persons in their 70's. Some women took the drug to end early pregnancies; men and other women took RU-486 to treat medical problems unrelated to abortion. Only 33 persons -- four men and 29 women -- were reported to have experienced adverse side effects. Three men and two women died; RU-486 was listed as the primary suspected cause of death. Dr. Beverly Winikoff, director of reproductive health for the Population Council, said:
One Canadian woman died in the year 2001 after having taking RU-486 to terminate a pregnancy. The cause of death was septic shock as a result of a clostridium bacterial infection. This is a bacterium that is commonly found "in soil and water, and occasionally in the gastrointestinal tract of animals and humans." Christina Horzepa, spokesperson for Population Council said: "We believe the death is unrelated to the drug." She said that clostridium infection is rare and has never been associated with medical abortion in the past. 6
2002-AUG-21: Three U.S. pro-life groups, Concerned Women for America, the Christian Medical Association, and the American Association of Pro-Life Obstetricians and Gynecologists petitioned the Food and Drug Administration to take RU-486 off the market immediately. They say that the pill is jeopardizing women's lives. They seem to have based their conclusions on the Food and Drug Administration report mentioned above; they cited two deaths and four serious side effects among women taking the pill. 7
2003-SEP-17: Holly Patterson, 18, of Livermore, CA, died of complications after taking RU-486 during 2003-SEP. She allegedly experienced bleeding and very severe cramps after taking the pill. She went to the hospital and was only given painkillers. She returned to hospital a few days later and died on SEP-17. Her father speculates that RU-486 induced a partial miscarriage. Fragments of the embryo left inside her uterus became infected and caused her to go into septic shock. A spokesperson for Danco Laboratories, the producer of RU-486 in the U.S. estimated that 200,000 women in the U.S. have used the pill. 8
Thus, we can conclude that:
Deaths apparently linked to unapproved procedure:
A group of four or five women who had taken RU486 died after having using a method not approved by the FDA. They died of sepsis, an infection of the bloodstream. The FDA procedure involves swallowing three Mifeprex tablets followed two days later by two misoprostol pills. However, studies had shown that if the misoprostol pills were administered vaginally, they were equally effective and had fewer side effects. This procedure had been recommended by most abortion clinics.
By early 2006, Planned Parenthood estimated that RU-486 had been used 560,000 times in the U.S. since the pill was authorized in the year 2000. The pill had a fatality rate of 1 in about 62,000 uses. This is about a quarter of the fatality rate if the pregnancies had been taken to childbirth. However, five of those women had followed an procedure that is not approved by the FDA. For those women who followed the FDA procedure, the fatality rate was 1 in about 140,000 abortions -- about a tenth of the fatality rate of continuing the pregnancy to childbirth, and roughly equal to the fatality rate of abortions by aspiration.
Some individuals who are opposed to the use of RU-486 are very concerned about the numbers of deaths.
The Associated Press stated that: "The FDA previously has said the abortion pill remains safe enough to stay on the market. The rate of sepsis is about one in 100,000 uses, comparable to infection risks with surgical abortions and childbirth." The FDA issued an alert on MAR-17 recommending that doctors and patients be aware of the possibility of infection following the use of RU-486. Symptoms of infection may include abdominal pain, nausea, vomiting, diarrhea, and weakness, with or without a fever. 9
Planned Parenthood Federation of America, Inc. said it would stop recommending vaginal insertion of misoprostol in favor of swallowing them as approved by the FDA. 10
The Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases convened a conference, on 2006-MAY-11. Attendees discussed Clostridium sordellii, a bacteria related to the deaths of four California women who had taken RU-486. Inside Bay Area reports:
Clostridium difficile will also be discussed. It is a different bacteria which has infected patients at hospitals and nursing homes and is unrelated to the abortion pill. 11
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