abortion-inducing drugs- legislative talking points

8/3/2019 Abortion-Inducing Drugs- Legislative Talking Points

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ABORTION-INDUCING DRUGS

Legislative Talking PointsFor the 2011 Legislative Year



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TALKING POINTS:

ABORTION-INDUCING DRUGS

ABORTION-INDUCING DRUGS POSE DRASTIC HEALTH RISKS FOR WOMEN:

Both the U.S. Food and Drug Administration (FDA) and drug manufacturers have acknowledged

that abortion-inducing drugs pose health risks for women, including the risk of death.

The Mifeprex (RU-486) drug manufacturer acknowledges that “[ n]early all of thewomen who receive Mifeprex and misoprostol [the RU-486 regimen] will report adverse

reactions, and many can be expected to report more than one such reaction.”1

These adverse reactions include abdominal pain, uterine cramping; nausea; headache;vomiting; diarrhea; dizziness; fatigue; back pain; uterine hemorrhage; fever, viral

infections; vaginitis; rigors (chills/shaking); dyspepsia; insomnia; asthenia; leg pain;

anxiety; anemia; leucorrhea; sinusitis; syncope; endrometritis/salpingitis/pelvic

inflammatory disease; decrease in hemoglobin greater than 2 g/dL; pelvic pain; andfainting.2

A European drug manufacturer has publicly stated that 29 women have died worldwideafter using RU-486.3

The FDA has acknowledged that at least 8 women in the U.S. have died due to serious

infections following medical abortion with mifepristone and misoprostol.4

Mifepristone, the first drug administered in the Mifeprex (RU-486) regimen, interfereswith the body’s immune response, allowing bacteria, if present, to flourish and cause

widespread, multi-organ infection in the woman.

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The causal chain between mifepristone and death by toxic shock syndrome has beendemonstrated in multiple animal models of septic shock, where the mortality rate

increased from 13 percent to 100 percent in mifepristone-treated animals.6

Even previously healthy women face a risk of fatal infection following the use of abortion-inducing drugs. From September 2003 through June 2005, the FDA reported

four U.S. deaths due to C. sordellii bacterial infection in women, ages 18-34, who had

undergone mifepristone abortions. These four U.S. women were reported by the U.S.Centers for Disease Control and Prevention (CDC) and FDA as having been previously

healthy, without any underlying immunoconditions. They had no risk factorspredisposing them to infection or death—especially from a bacterium that rarely affectshumans with a normal immune system.7

During an investigation by the U.S. House Subcommittee on Criminal Justice, Drug

Policy and Human Resources, it was discovered that by May of 2006, the FDA

acknowledged a total of 1070 adverse reports related to the use of RU-486. These



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adverse events included six deaths, nine life-threatening incidents, 232 hospitalizations,116 blood transfusions, and 88 cases of infection. 8

In the U.S. trials, only 92.1 percent of women had a complete medical abortion after

ingesting mifepristone in the first 49 days gestation. The remaining 7.9 percent required

surgical intervention.9

ABORTION-INDUCING DRUGS POSE DRASTIC HEALTH RISKS FOR

SUBSEQUENTLY-BORN CHILDREN:

Abortion-inducing drugs are not 100 percent effective. Many women go on to have surgical

abortions or carry their children to term. Thus, the risk to children born after “botched”

abortions is of utmost concern, as is the risk to children of mothers who are breastfeeding at the

time the drugs are ingested.

For children that survive abortion by drugs like Mifeprex (RU-486), skull defects, cranialnerve palsies, delayed growth and psychomotor development, facial malformation, and

limb defects have all been reported after exposure during the first trimester.10

Further, it is not known whether mifepristone is excreted in breast milk.11

ABORTION-INDUCING DRUGS HAVE NOT BEEN ADEQUATLEY TESTED:

Before the FDA approved Mifeprex (RU-486), clinical testing on its safety and efficacy was

minimal. Several ages and categories of women were not studied, yet the drug regimen is

administered to women of all ages and lifestyles. The lack of information about the safety of thedrug substantially elevates the risk of harm for women, especially in light of the fact that the

abortion industry does not properly screen or even examine women before administration of abortion-inducing drugs.

The Mifeprex (RU-486) label acknowledges that the U.S. clinical trials tested safety and

efficacy only in women aged 18 to 45 years old.12

Safety and efficacy in pediatricpatients has not been established, despite the fact that abortion providers routinely

provide the RU-486 drug regimen to minors.

The drug label states that the “effects of age, hepatic disease and renal disease on the

safety, efficacy and pharmacokinetics of mifepristone have not been investigated.”13

There is no data on the safety and efficacy of mifepristone in women with chronic

medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renaldisease; insulin-dependent diabetes mellitus; or severe anemia.14

There is no data on the safety and efficacy of mifepristone in women who are heavy

smokers.15



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Specific drug or food interactions with mifepristone have not been studied.16

No long-term studies to evaluate the carcinogenic potential of mifepristone have beenperformed.17

ABORTION-INDUCING DRUGS ARE CONTRAINDICATED IN CERTAIN SITUATIONS

Abortion-inducing drugs have not been tested on certain categories of women, and for somewomen the drugs are completely contraindicated. Women in rural areas who may not have

access to proper medical care—i.e., those women targeted by abortion providers as “needing”abortion-inducing drugs—are the very women who are most vulnerable to complications.

Mifepristone is contraindicated when there is confirmed or suspected ectopic pregnancy

or undiagnosed adnexal mass; an IUD in place; chronic adrenal failure; concurrent long-

term corticosteroid therapy; history of allergy to mifepristone, misoprostol, or otherprostaglandin; hemorrhagic disorders or concurrent anticoagulant therapy; inherited

porphyrias.18

An examination is necessary to ensure that there are no contraindications.

Mifepristone is contraindicated if a patient does not have adequate access to medicalfacilities equipped to provide emergency treatment of incomplete abortion, blood

transfusions, and emergency resuscitation during the period from the first visit untildischarged by the administering physician.19 Thus, it is contraindicated for those very

women the abortion industry is targeting.

ABORTION-INDUCING DRGS ARE PURPOSELY MIUSED BY ABORTION

PROVIDERS:

Mifeprex (RU-486) was approved by the FDA only through 49 days gestation, and is to be

administered orally and in a clinic or medical office. However, abortion providers are defying

the protocol tested and approved by the FDA, and instead utilizing their own dangerous“evidence-based protocol.”

Treatment with Mifeprex (RU-486) and misoprostol require three office visits.20

Mifeprex (RU-486) is indicated for use in the termination of pregnancy through 49 days

gestation and has no other approved indication for use during pregnancy.21

The Mifeprex (RU-486) tablets are intended for oral (not buccal) administration only, andshould be administered only in a clinic, medical office, or hospital, and by or under the

supervision of a physician able to assess the gestational age of an embryo and to diagnoseectopic pregnancies.22



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Patients should be scheduled for and return for a follow-up visit at approximately 14 daysafter administration of mifepristone to confirm that the pregnancy is completely

terminated and to assess the degree of bleeding.23

A clinical examination or ultrasonographic scan is necessary to confirm the completetermination of pregnancy after the procedure.

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In at least two courts and in multiple media outlets, abortion providers have admitted topurposely distributing RU-486 to women contrary to the way in which it was tested and

approved by the FDA.25

Abortion providers provide the drug regimen through at least 63 days gestation and someinstruct women to take the second dose of the regimen vaginally, and at home and away

from physician supervision.26

Abortion providers also acknowledge instructing women touse the second dose buccally (i.e., dissolving the pill against the gum).27

Many abortion providers are now providing abortion-inducing drugs like Mifeprex (RU-

486) through teleconferencing systems and may not even be in the same physicalbuilding as the woman seeking an abortion, increasing the risk of misdiagnosed ectopic

pregnancy or other contraindication.

FAILING TO ABIDE BY THE FDA PROTOCOL IS DANGEROUS:

Abortion-inducing drugs like Mifeprex (RU-486) pose risks for women when used according to

the protocol tested and approved by the FDA; but these risks increase when abortion providers

purposely misuse the abortion-inducing drugs. Regulation of such drugs is imperative in theeffort to protect the health and welfare of women victimized by the abortion industry.

Dr. John P. Seward, Board Member of the American Medical Association, testifiedbefore a House Subcommittee in 1990 that “It is the AMA’s understanding that RU-486

poses a severe risk to patients unless the drug is administered as part of a complete planunder the supervision of a physician….”28

Because symptoms of ectopic pregnancy mimic the symptoms of completed mifepristone

abortions, ectopic pregnancies go easily undiagnosed.29 Improper screening and failure

to follow the FDA protocol (specifically, for follow-up evaluation and care) place the

lives of women with unknown ectopic pregnancies at even greater risk of death byruptured ectopic pregnancy.

Providing Mifeprex (RU-486) outside of the 49-day time period tested by the FDA isdangerous. It is generally understood that the percentage of incomplete mifepristone

abortions requiring emergency surgical intervention increases with gestational age.

Mifepristone’s failure rate is 8 percent at 49 days gestation, 17 percent at 50-56 days



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gestation, and 23 percent at 57-63 days gestation. Thus, as the failure rate of RU-486increases with gestational age, so does the medical risk.

In addition to the increased risk of necessary surgical intervention, abdominal pain,

nausea, diarrhea, and vaginal bleeding also increase with advancing gestational age.30

In 7 of the 8 women in the United States reported to have died after using RU-486,misoprostol (the second drug in the Mifeprex regimen) was used intravaginally instead of

orally.31 The eighth woman died after buccal use.32

ABORTION PROVIDERS PUT PROFIT ABOVE WOMEN’S HEALTH

Despite the fact that abortion-inducing drugs pose risks that are especially dangerous when the

FDA-approved protocol is not followed, the abortion industry continues to misuse the drugs,clearly placing their own profiteering above the health and welfare of women.

Providing abortion-inducing drugs past 49 days gestation means that the abortion

providers can “serve” more women with the drugs.

Failing to examine women or schedule follow-up examinations means that the abortionproviders can “serve” more women with the drugs in a single day.

If an abortion provider administers the drug via teleconferencing, then the abortion

provider can serve more women in the state without traveling.

The more women “served,” the larger the profit margin for the abortion providers.

STATE OF THE STATES:

Four states maintain comprehensive regulations of abortion-inducing drugs and/or

prohibit “telemed abortions”: KS, NE, SD, and TN.

Five states specifically impose minimal administrative regulations on the dispensation of

abortion-inducing drugs: CA, GA, MO, RI, and TX.

Four state laws regulating abortion-inducing drugs are in litigation: AZ, ND, OH and OK.

1 See Mifeprex Label, available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.htm (last

visited Jan. 14, 2011) (emphasis added); see also Staff Report, The FDA and RU-486: Lowering the Standard for

Women’s Health, prepared for the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and



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Human Resources, at page 30 (Oct. 2006), available at

http://www.usccb.org/prolife/issues/ru486/SouderStaffReportonRU-486.pdf (last visited Jan. 14, 2011).

2 See Mifeprex Label, supra; see also Staff Report, supra, at page 30.

3 See, e.g., APM Health Europe, Italy questions safety of Exelgyn's abortion pill, approval still not granted (June 23,

2009), available at

http://www.apmhe.com/story.php?mots=MIFEPRISTONE&searchScope=1&searchType=0&numero=L15579 (last

visited Aug. 23, 2010).

4 FDA, Mifeprex Questions and Answers (updated Feb. 24, 2010), available at

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111328.htm

(last visited Jan. 14, 2011).

5 See, e.g., J.I. Webster & E.M. Sternberg, Role of the Hypothalamic-Pituitary-Adrenal Axis, Glucocorticoids and

Glucocorticoid Receptors in Toxic Sequelae of Exposure to Bacterial and Viral Products, J. ENDOCRINOLOGY,

181:207-221 (2004); R.P. Miech, Pathophysiology of Mifepristone-Induced Septic Shock Due to Colstridium

Sordellii, ANNALS OF PHARMOCOTHERAPY (Sept. 2005), at 39. See also Staff Report, supra, at 13-14, 33.

6 FDA Public Health Advisory: Sepsis and Medical Abortion (updated Jan. 27, 2010), available athttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInfor

mationforHeathcareProfessionals/PublicHealthAdvisories/UCM051734 (last visited Jan. 27, 2011); Emerging

Clostridial Disease Workshop, at 91, 108, 115 (CDC-FDA-NIH Transcript May 11, 2006) (CDC Workshop);

Sternberg, Proceedings of the Nat’l Acad. Sci. 86: 2374-78 (1989); Statement by Donna Harrison, M.D., for RU-

486: Demonstrating a Low Standard for Women’s Health?, Hearing before the Committee on Government Reform,

House of Representatives (May 17, 2006), Serial No. 109-202, at 135, 138.

7 See, e.g., FDA Public Health Advisory: Sepsis and Medical Abortion, supra; CDC Worship, supra; See M. Fischer

et al., Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical Abortion, N.E. J. MED.

353:2352, 2352-53, 2356 (2005); Statement by Donna Harrison, supra, at 135, 139.

8Staff Report, supra, at page 25.

9 See Mifeprex Label, supra.

10 Id .

11 Id .

12 Id .

13 Id .

14 Id .

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Id .16 Id .

17 Id .

18 Id .

19 Id .



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20 Id .

21 Id .

22 Id .

23 Id .

24 Id .

25 See, e.g., Planned Parenthood Cincinnati Region v. Taft , 459 F. Supp. 2d 626, 630 n.7 (S.D. Ohio 2006); Planned

Parenthood Arizona Inc. v. Goddard , Minute Entry, CV 2009-029110 (Super. Ct. Ariz., Maricopa County Feb. 17,

2010); Faraway doctors give abortion pills by video, DES MOINES REGISTER (May 16, 2010), available at

http://www.9news.com/news/local/article.aspx?storyid=140688&catid=188 (last visited Jan. 26, 2011); Planned

Parenthood to Offer Abortion Pills, STATE JOURNAL-REGISTER (Sept. 23, 2009), available at http://www.sj-

r.com/health/x576519774/Local-Planned-Parenthood-to-offer-abortion-drugs (last visited Jan. 26, 2011).

26 See, e.g., Taft , 459 F. Supp. 2d at 640; Goddard , Minute Entry, supra.

27 See, e.g., MKB Management Corp. v. Burdick , N.D. East Central Judicial Dist. 11-02205 (Memorandum inSupport of Plaintiffs’ Motion for Temporary Injunction, July 18, 2011).

28 Statement of Dr. John P. Seward, Board Member, American Medical Association, for RU-486: The Import Ban

and its Effect on Medical Research, Hearing before the House Subcommittee on Regulation, Business Opportunities

and Energy, Committee on Small Business (Nov. 19, 1990). See also Staff Report, supra, at 8.

29 ACOG Practice Bulletin, Clinical Management Guidelines for Obstetrician Gynecologists: Medical Management

of Abortion, 26(4):1-20 (2001); B.C. Calhoun & D.J. Harrison, Challenges to the FDA Approval of Mifepristone,

ANNALS OF PHARMOCOTHERAPY (Jan. 2004), at 165.

30 Calhoun & Harrison, supra, at 165; I.M. Spitz et al., Early Pregnancy Termination with Mifepristone and

Misoprostol in the United States, N.E. J. MED. 338:1241-47 (1998).

31 Food and Drug Administration, Mifeprex Questions and Answers (updated Feb. 24, 2010), available at

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111328.htm

(last visited Mar. 18, 2011).

32 Food and Drug Administration, Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011

(July 19, 2011), available at

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM

263353.pdf (last visited July 21, 2011).

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