Transcript Slide 1

What are the differences and similarities
in their action and application ?
Linda Daguerre
History Unfolds…
•2000- the FDA approves RU486, the Abortion Pill aka
Early Option Pill, for early medical abortions (nonsurgical) in the United States.
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•1999- FDA approved morning after pill, Plan B
•1998- FDA approved morning after pill, PREVEN
•1997 FDA declares emergency contraception safe
and effective in the U.S.
1997- Much controversy surrounds RU486 by Right to
Life and religious groups. Drug’s introduction is delayed
in U.S. indefinitely.
1996- The Population Council submits drug application to
FDA recommending RU486 as a safe and effective abortion
method.
1988-RU486 approved in France.
1980- Researchers at Roussel-Uclaf, a French pharmaceutical company
develop Mifepristone (RU486).
1974- Albert Yuzpe, a Canadian Gynecologist publishes first studies on women’s
post-coital contraception by administering combination hormones.
1960(s)- Clinicians in France legally prescribe oral contraceptives “off label”
to protect from pregnancy AFTER intercourse.
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Fertilization: When sexual intercourse allows
the male’s sperm (gamete) to reach the
woman’s mature egg (ovum) at which
the combination forms a cell ( zygote).
Coitus or Coital- Sexual Intercourse
Contraceptives (tion)- Any artificial method of birth control
( birth control pills, condoms, IUD,
hormone injections, etc.)
Abortion:
Medical, surgical or chemical means of
terminating a pregnancy.
Abortifacient: A medication that induces or causes
an abortion ( not an EC)
Emergency Contraception (EC)- a method
implemented within 5 days of unprotected
sexual intercourse (72 hours recommended)
to stop fertilization from occurring,
preventing pregnancy.
Conflicting answers from biologists, physicians,
researchers, right to life groups and clergy leave us with
different answers, however, a few facts are certain:
Both sperm and ova ( the woman’s eggs) are living organisms, so when
fertilization begins, it is a relevant time to begin charting a new life. When
a fetus reaches day 21, the tiny heart begins to beat.
7 weeks
18 Weeks
A 25 week old preemie
What is the Morning After Pill?
The Morning After Pill also referred to as
emergency contraception (EC), is a high dose
of hormones taken within a specified number of days or
hours following unprotected sexual intercourse to
interrupt the fertilization process, therefore preventing
pregnancy.
Not effective if subject is already pregnant.
How does the Morning After Pill
Prevent Pregnancy?
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It stops ovulation, so the egg cannot be
fertilized. High doses of hormones make
it impossible for fertilization to occur.
No fertilization,
Egg is never released
Therefore , no
Are there RISKS or
Side Effects with the
Morning After Pill ?
A
As with most medications, the Morning After Pill has some incidence
a
of mild to moderate side effects in some women.
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Single hormone drugs, as in Plan B:
These are severe side effects and
need to be reported to your
physician.
Irregular menstrual periods
headaches
breast pain
upset stomach
dizziness
acne
Bleeding for extended time,
lack of menstrual periods or
severe stomach pain
Not
e
Combination hormones, as in Preven and the Yuzpe method,
may increase risk of breast cancer, endometrial cancer and liver
tumors.
COST AND AVAILABILITY
The Morning After
Emergency Contraceptives are very affordable and
easy to obtain:
1. Any licensed physician may prescribe ( Urgent Care,
Family Physicians, Family Planning Clinics),
although many may not be willing due to
controversial nature.
2. Many college campus health centers may dispense,
although at this time, COS does not.
• Abortion Clinics and Free Clinics
Prices range from $20-$25, plus office visit
( these prices are approximate and may be
higher depending on the physician’s fees)
What is
 RU486 also referred to as the “abortion
pill”, is a two part therapy/regime known as an
abortifacient, which terminates an early pregnancy
(within 9th week ) by robbing the uterine lining of
progesterone, a hormone vital to sustaining pregnancy.
How the abortion pill
actually works
Of the 2 Medications taken:
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Mifepristone, keeps the
progesterone( a hormone vital
to sustaining pregnancy) from
nourishing the uterine lining.
(endometrium)
Misoprostol, causes the uterus
to contract, expelling the
pregnancy tissue.
Where can I get the abortion pill ?
1. Only medical doctors that are licensed to perform
surgical abortions are able to prescribe RU486.
2. Family Planning Clinics and Abortion Clinics have
these available upon examination and confirmation
of early pregnancy.
3. College health centers cannot prescribe this regimen,
however, can provide information, referrals and
counseling in most cases.
FYI
Depending on the physician’s stand on
abortion, even if able to prescribe, many would
not be willing due to personal judgements.
Costs vary depending on geographical location:
1. $300-$600, depending on income
2. Some insurance companies will
cover this expense, Medi-Cal
included.
4. Fees usually include ultrasound,
lab work and 3 office visits.
** Additional fees may apply if a surgical abortion
is still needed after patient has undergone
pharmaceutical therapy without complete
results.
Side Effects of RU486
67% nausea
34% vomiting
32% headaches
23% diarrhea
97%
abdominal
cramping
9
7
%
* Percentages overlap due to incidence in more than one side
effect per person
Potential
to RU486?
Safety and health are the primary concern when taking this
therapy of combined medications.
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Severe abdominal cramping
Hemorrhaging ( heavy bleeding)
Pulmonary Embolism ( blood clot in lung)
Incomplete Abortion-surgical abortion
may still be necessary.
Maternal Death ( death of mother)
There are many lesser side effects that are possible with
this medication that may include headaches, nausea, fever
and diarrhea.
Effectiveness of RU486
& Morning After Pill
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The Food and Drug Administration has found that
RU486 if taken as prescribed , the effectiveness is
from 95%-98% , with little side effects. Misoprostol, which
is the second part of this regimen is a large part of its
success, usually giving complete results within 24 hours of
taking second pill.
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The Morning After Pill, also if taken as prescribed has a
success rate of 89% in prevention of pregnancy after
unprotected intercourse, with few side effects.
Not
Greenland
AK
Canada
Europe
Russia
US
Not Africa
Not India
Malaysia
Taiwan
Limited in
So. America
Not Australia or
some
some
New Zealand
** Within Europe, Italy, Ireland, Portugal and Luxemborg not approved.
These are countries that have gained approval for RU486. EC’s are usually approved in these
Countries prior to abortion pill, unless otherwise noted.
AS OF TODAY:
• The United States is fighting against a potential
abortion pill due to many recent deaths. Cause
is still being investigated.
• Morning After Pill- Controversy is surrounding the
question on whether to make EC’s over the counter.
Decision may include age restriction on medications
to include parental consent for minors.
• Australia continues to rally for approval on RU486,
but government doesn’t indicate any possibilities
that approval is imminent.
• Since it is not approved in many developing countries,
black market pills are being sought and purchased.
•This remains one of the most controversial topic across
nation and throughout the world in politics, religion,
medical and pro-choice/pro-life groups everywhere.
1 out of 5 pregnancies in the world end in abortion.
WE NOW KNOW THIS…
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Very controversial
Carries higher risks if
not taken properly.
Is not available every-where.
Costly
Many countries are trying to get
approved for use.
Limited to persons without chronic
medical
Conditions.
95%-98% effective
Only to be taken if pregnant
Does NOT protect against
Sexually Transmitted Diseases
The FDA now recommending that
any symptoms of vomiting, fever
or diarrhea be treated immediately
antibiotics.
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Controversial in many areas.
Available in many areas with
examination.
Side effects in high doses
of hormones increased.
Affordable
89% Effective- higher if taken
within first 24 hours following
sexual intercourse.
Does NOT protect against
Sexually Transmitted Diseases
Not to be taken if pregnant.
Resources Cited
1. Critchlow, Donald T., The Politics of Abortion
and Birth Control in Historical Perspective,
pp.75-79, University Park, PA, The Pennsylvania
State University Press, 1996
2. Laden, Lawrence A Private Matter, Amherst, NY,
pp.115-118,142-143, 215-218, Prometheus Books, 1995
3. The Encyclopedia of Birth Control, pp. 106-108,
Santa Barbara, CA 2001
4. The Reproductive System, Westport, CT, Greenwood
Press, 2004
Web Resources
1. Health and Reproductive Rights: Emergency Contraception, National Women’s Law Center, November 2005
www.nwlc.org
Web Resources-continued
1. FDA Issues warning on abortion pill deaths, July 20, 2005
Http://www.countrywatch.com
2. What you need to know about RU486, Feb/Mar 2001,
SIRS Researcher, links to abortion, then mifepristone
3. FDA needs to act on Morning After Pill, Sept.9, 2005,
SIRS Researcher, search emergency contraceptives and
scroll to article.
4. The Morning After Pill: Dosages, Applications, Risks and
Frequently Asked Questions, March 2006,
Http://ec.princeton.edu also under
Http://www.not-2-late.com
5. Health: Planning on Plan B, Newsweek, Inc.,
February 20, 2006, p16
6. RU486 in the News, Where to get RU486, Side Effects,
http://RU486Facts.org