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Life / Abortion Issues: RU486: The Abortion Pill
Risks and Dangers
On September 28, 2000, the United States Food and Drug
Administration approved the marketing of the RU486 abortion
pill in the United States. The Clinton-Gore Administration,
which claimed it wanted to make abortion rare, embraced this
drug-induced abortion technique which undoubtedly will
result in more abortions and new risks to women.
Risks and Dangers
Despite heavy publicity by the pill's promoters claiming
that the RU486/prostaglandin method is a safe and effective
alternative to surgical abortion, 1,5 controlled testing has
offered a very different picture.
Is it Dangerous?
In France, a woman suffered heart failure and died after
taking RU486 in combination with its accompanying
prostaglandin.2 In America, one of the women participating
in the U.S. trial of RU486 nearly bled to death after taking
the abortion drugs (See An Iowa Doctor Gives A First Hand
Account below)
Every RU486 abortion involves at least two drugs, RU486
(also called "mifepristone") and a prostaglandin (PG),
usually misoprostol. These drugs are dangerous for a number
of reasons.
RU486 is a complex chemical molecule effecting multiple
systems of the body.3 This is why it has effects not only on
a woman's reproductive system, but her cardiovascular,
digestive, and central nervous systems as well.3 Misoprostol,
the prostaglandin ordinarily used in conjunction with RU486,
has its own side effects, triggering the painful, often
nauseating, contractions that expel the dead baby. 4
Because of the pain, bleeding, nausea, fevers, and other
side effects, these drugs are often further supplemented by
additional drugs such as antispasmodics, 5 antibiotics,
narcotic analgesics, etc.,3 each of which comes with its own
attendant risks and side effects and potential interaction
problems.
In England, one of just five countries (including the
U.S.) where the drug is allowed, all pills are numbered to
ensure that they are not released to untrained personnel.
3
In France, the country with the most experience with the
drug, the government requires that any facility dispensing
the drug have an electrocardiograph and emergency
resuscitative equipment nearby. 6
Does it sound safe and simple to you?
Nasty Side Effects: Part of the Package
- PAIN: 79% - 96% of women taking the
RU486/PG combination reported pain, 4,17 so bad that as many
as half required some form of analgesia, whether an opiate
or some other injectable pain killer. 3,4,5,17
Three researchers who reviewed much of the data on RU486 say
"many of the women in these studies experienced pain for
several days/weeks until the abortion was complete. Thus we
are talking about prolonged, not transient pain, although
this is rarely noted." 3
- NAUSEA, DIARRHEA, and VOMITING: Between 24% and
61% of RU486/PG patients experience nausea as part of the
procedure. About one in five of all women struggle with
diarrhea, while 15.3% - 26% or up to a quarter, vomit.
3,5,17
- INFECTION: In one trial, as many as 5%, or 1 in
20, showed signs and symptoms of infection. 9 Fevers and
chills, often indications of infection, are not unexpected
side effects of the process.5 Antibiotics often must be
prescribed for suspected infections. 10 If and when an
RU486/PG abortion is unsuccessful (anywhere from 5% - 20% of
the time 11, 12), and there is an incomplete abortion, the
risk of infection is much greater. 13, 14 Whatever supposed
benefit chemical abortion has over surgical abortion is then
lost when a woman undergoes the surgical procedure with its
attendant risks.
- OTHER SIDE EFFECTS: Fatigue, 13 fainting, skin
conditions, anemia, asthenia, hot flashes, heart
palpitations, breast conditions, 5 mood changes, thirst.
14
- LONG TERM CONSEQUENCES: Unknown. Few independent
studies. RU486 does cross the blood follicle barrier and get
into a woman's ripening eggs. 3 Could this effect the
reproductive systems of a woman's later children, as DES
did?
SAFETY WARNING
Women with any of the following conditions
were kept out of tests of RU486 for fear that the
drug might prove dangerous or deadly for them.
- Presence of cardiovascular risks, including
high blood pressure, obesity, cigarette smoking,
and diabetes §, 17
- Asthma and bronchitis ±
- Age over 35 or under 18 §, 17
- Anemia or blood clotting disorders §
- Menstrual irregularity, fibroids or
endometriosis §
- Use of IUD or oral contraceptive less than 3
months prior to conception §, 17
- History of problem pregnancy, current
ectopic pregnancy, or pelvic inflammatory
disease *, 17
- Allergies, epilepsy, or adrenal
insufficiency ±
- Recent intake of steroid or
anti-inflammatory medications ±
- Long term administration of cortisone or
similar drugs ±, *
- History of liver, stomach, intestinal, or
kidney disease *, 17
If only women in perfect physical condition
can endure the drug..... How safe can it be?
§ Raymond, RU486: Misconceptions (1991); ±
Silvestre, NEJM, 3/8/90; *Couzinet, NEJM, 12/18/86
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How Bad is the Bleeding?
Researchers regard heavy, prolonged bleeding as the chief
problem and most serious side effect of chemical abortions.
3 The average blood loss from an RU486 abortion is reported
to be 70ml, nearly four times the average blood loss from a
normal suction curettage abortion 15 and very close to the
80ml menstrual blood loss level doctors consider Aabnormal.@
16 This is hardly the Aheavy period@ spoken of by some of
the pill=s promoters. 18
In a 1990 British study, five out of 579, or nearly 1%,
bled so much they required both transfusions and curettage
to stop the bleeding. 3 In U.S. trials with a new
prostaglandin (misoprostol) that was supposed to resolve
such problems, Aexcessive bleeding@ was noted in 4 out of
230 women who participated in the Des Moines part of the
study. 12 What Aexcessive bleeding@ means is unclear, but we
do know one of those women almost bled to death (see An Iowa
Doctor Gives a First Hand Account below). Several women in
the U.S. trial had to be given uterotonic agents to stop the
bleeding.17
It is not merely the amount of blood lost but how long a
woman bleeds that is a medical concern. Normally, the
bleeding may last one or two weeks, but there are records of
women bleeding as much as two months or more. 3,5,17
There is additional concern because only about half of
women who take RU486 actually abort at the doctor=s office,
meaning 50% or more face their bleeding and aborting without
medical supervision.17
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An Iowa Doctor gives a first hand account
The woman who took RU486... and nearly died
Between October 1994 and Labor Day of 1995, a
nationwide trial of RU486 was conducted. A Planned
Parenthood clinic in Des Moines was one of the
testing sites. News accounts said the trial went
well without any problems. One Iowa doctor who saw
the story said he knew better.
I could hardly believe my eyes when I read the
first paragraph of an article in the Sept. 2, Des
Moines Register, "The clinical test of the 'abortion
pill' has ended in Iowa, with no complications among
238 women who ended unwanted pregnancies without
surgery."
This is untrue, and I can only surmise that the
reason must have to do with the political volatility
of the abortion issue. Regardless, it is imperative
from a scientific standpoint that if Planned
Parenthood is to be part of a nationwide clinical
trial, it must report the facts whether they agree
with them or not ... (A)
In November 1994, I was called to the Alan
Hospital Emergency Room in Waterloo, Iowa, for a
woman who was bleeding due to a miscarriage and was
in obvious shock. A blood test showed that she had
lost between one-half to two-thirds of her blood
volume. For those of you who understand this, her
hemoglobin was 5.8 and her hematocrit was 17.3. Her
blood pressure was 90 over 60, her pulse was 120,
she was in obvious shock.
I had thought she was having an incomplete
miscarriage, but her husband took me into the hall
and told me that she had taken RU486 approximately 2
weeks before. It was my clinical opinion that she
would die soon if she did not have an immediate D&C.
Without even doing the routine preparation we
normally do for surgery, I realized that I had to
take her immediately to surgery to save her life. I
took her to the operating room and removed the
contents of her uterus surgically. I gave her two
units of packed red blood cells intraoperatively.
Even later that evening, 2 hours post-transfusion of
those two units, her hemoglobin was still 6.8 and
her hematocrit was 20 something. She required two
more units of blood because she was still
orthostatic and symptomatic....(B)
To report to the people of Iowa, the Population
Council, and to the FDA that there were "no
complications" in Iowa is simply not true...(A)
If near death due to the loss of half of one's
blood volume, surgery, and a transfusion of four
units of blood do not qualify as a complication, I
don't know what does. (A)
How did the clinic and the trial sponsor respond?
[President of Planned Parenthood of Central Iowa
Jill] June said "no complications" refers to the
trial -- that the trial was conducted successfully
-- and not to the condition of the participants.
However, Sandra Waldman, a spokeswoman for the
New York based Population Council, which sponsored
the trial, said the trial resulted in "no deaths or
serious complications." When asked whether
Louviere's patient's experience qualifies as a
serious complication, Waldman said it would be
"within the context with what happened before [in
France]."(C)
Sources:
A. Dr. Mark Louviere, Waterloo Courier, 9/24/95.
B. Statement of Mark Louviere, MD, FDA
Mifepristone (RU486) Hearings, 7/19/96.
C. Tom Carney, Des Moines Register, 9/21/95
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Complications
There are over 1.3 million abortions performed in the
U.S. each year. 7
We are told that 20-33% of abortions performed in France
are chemical abortions. 8, 18
If U.S. use mirrored French use, and U.S. abortion rates
remained stable, one could expect the following numbers of
complications bases on current clinical data:
|
COMPLICATION |
EXPECTED U.S. RANGE |
RESULTING #'s of COMPLICATIONS |
|
8% failure to complete abortion |
X
280,000 - 462,000 |
14,000 - 23,100 "failures" per year |
|
2% hemorrhaging |
X
280,000 - 462,000 |
5,600 - 9,240 hemorrhaging per year |
|
2% surgical intervention to stop bleeding
|
X
280,000 - 462,000 |
5,600 - 9,240 surgical interventions/yr |
|
1% require hospitalization |
X
280,000 - 462,000 |
2.800 - 4,620 hospitalizations per year |
|
(4) transfusions |
X
280,000 - 462,000 |
528
- 871 transfusions per year |
NOTES: 1. Baulieu, the AAbortion Pill@ (1991);
Baulieu, in Clinical Applications of Mifepristone...(1993);
Lang, Vogue, August 1998. 2. Riding, NY Times, 4/10/91. 3.
Raymond, et al, RU 486: Misconceptions (1991). 4. McKinley,
Human Reproduction (1993), pp. 1502-5. 5. FDA, Mifepristone
Hearings, 7/19/96. 6. French Government Letter, April 12, 1990.
7. Henshaw, AAbortion Services in the United States 1995-1996,@
Family Planning Perspectives, (Nov/Dec 1998) 8. Gianelli,
American Medical News, 4/12/93. 9. Birth Control Trust,
Confernece, 4/22/93. 10. WHO Study, Fertility & Sterility (1991)
11. Aubeny and Baulieu, C.R. Acad Sci. Paris (III), (1991),
pp.539-545. 12. Jouzaitis, Chicago Tribune, 8/30/95. 13. Sitruk-Ware,
Contraception (1990), pp. 221-243. 14. Li, Fertility & Sterility
(1988), pp. 732-742. 15. Ob. Gyn News (1989), No. 24, p.1. 16.
Speroff, Clinical Gynecological Endocrinology & Infertility, 3rd
ed. (1983). 17. Spitz, NEJM, 4/30/98. 18. Population Council,
Website, www.popcouncil.org, 1/98.
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