Many pro-life groups believe that RU-486 is unsafe:
The National Right to Life Committee state that RU-486 pills "offer
a whole new set of significant risks." They are concerned that the pill
makes abortion too easy. It gives "supporters of abortion a chance to
change the image of abortion, making it seem as simple as taking a pill."
An essay on an unofficial Roman Catholic web site comments: "As far
as safety is concerned, complete cardiovascular collapse and death
immediately following administration of RU486 has been reported in the
European medical literature." 1
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:
heart problems, or
high blood pressure.
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:
RU-486: 1 death in 200,000 abortions.
Vacuum aspiration abortion: 1 death in 200,000 abortions
Childbirth 1 death in 14,300 pregnancies
Illegal abortions 1 death in 3,000 abortions. 2,3
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. 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: "These
are not side effects. This list is a list of things that happened to women who
took this drug for any reason, and it's anything that happened to them after
they took the drug. But it's not necessarily a drug side effect." 5
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 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
Assuming that the California teenager died as a result of taking RU-486,
The death rate among the 200,000 who had taken RU-486 in the past was 1 in 200,000.
If those 200,000 women had decided to not take RU-486 and had chosen a
vacuum aspiration abortion, then 1 in 200,000 would probably have died due
to the abortion.
If the 200,000 women had decided to not have an abortion but had
continued with their pregnancies, then 14 in 200,000 would have died as a
result of their pregnancy.
Thus, we can conclude that:
To pro-choicers, the use of RU-486 prevented the birth of 200,000
unwanted babies and prevented the deaths of 13 women.
To pro-lifers, the use of RU-486 caused the deaths of 200,000 humans:
about 1 adult and 200,000 embryos -- which they consider to be human
Forcing women seeking abortions to undergo surgical abortions instead of
using RU-486 would have no impact on the death rate from abortions.
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
Some individuals who are opposed to the use of RU-486 are very concerned
about the numbers of deaths.
Rep. Chris Smith, (R-NJ) said: "How many deaths,
investigations and warnings will it take before RU486 is properly labelled
as lethal and removed from the market?"
In the Senate, Jim DeMint (R-SC) and Tom Coburn
(R-OK) are promoting a bill to suspend sales of RU-486 until the Government
Accountability Office studies the FDA's approval procedure. The bill is
informally called "Holly's Law" and is named after Holly Patterson, a teenager,
died after taking the pills. DeMint said: "RU-486 is a deadly drug that is
killing pregnant women. This drug should never have been approved, and it must
be suspended immediately."
Patterson's father said: "The bottom line is
that this is not about the abortion debate. This is about the safety, health and
welfare of women."
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 are convening a conference, on 2006-MAY-11. Attendees will discuss
Clostridium sordellii, a bacteria related to the deaths of four California women
who had taken RU-486. Inside Bay Area reports:
"While scientists and health officials have confirmed that the women
shared the unusual bacterial infection, they are unsure how they contracted
it and whether it is related to Mifeprex" or Misoprostol.
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
The following information sources were used to prepare and update the above
essay. The hyperlinks are not necessarily still active today.