ABORTION-INDUCING DRUGS

Legislative Talking Points

For the 2011 Legislative Year

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 the women 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; and fainting.2 A European drug manufacturer has publicly stated that 29 women have died worldwide after 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, interferes with the bodys immune response, allowing bacteria, if present, to flourish and cause widespread, multi-organ infection in the woman.5 The causal chain between mifepristone and death by toxic shock syndrome has been demonstrated 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 factors predisposing them to infection or deathespecially from a bacterium that rarely affects humans 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

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, cranial nerve 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 the drug 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 pediatric patients 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 renal disease; 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

Specific drug or food interactions with mifepristone have not been studied.16 No long-term studies to evaluate the carcinogenic potential of mifepristone have been performed.17

ABORTION-INDUCING DRUGS ARE CONTRAINDICATED IN CERTAIN SITUATIONS Abortion-inducing drugs have not been tested on certain categories of women, and for some women the drugs are completely contraindicated. Women in rural areas who may not have access to proper medical carei.e., those women targeted by abortion providers as needing abortion-inducing drugsare 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 longterm corticosteroid therapy; history of allergy to mifepristone, misoprostol, or other prostaglandin; 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 medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged 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, and should 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 diagnose ectopic pregnancies.22

Patients should be scheduled for and return for a follow-up visit at approximately 14 days after 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 complete termination of pregnancy after the procedure.24 In at least two courts and in multiple media outlets, abortion providers have admitted to purposely 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 some instruct 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 to use the second dose buccally (i.e., dissolving the pill against the gum).27 Many abortion providers are now providing abortion-inducing drugs like Mifeprex (RU486) through teleconferencing systems and may not even be in the same physical building 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 the effort to protect the health and welfare of women victimized by the abortion industry. Dr. John P. Seward, Board Member of the American Medical Association, testified before a House Subcommittee in 1990 that It is the AMAs understanding that RU-486 poses a severe risk to patients unless the drug is administered as part of a complete plan under 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 by ruptured ectopic pregnancy. Providing Mifeprex (RU-486) outside of the 49-day time period tested by the FDA is dangerous. It is generally understood that the percentage of incomplete mifepristone abortions requiring emergency surgical intervention increases with gestational age. Mifepristones failure rate is 8 percent at 49 days gestation, 17 percent at 50-56 days

gestation, and 23 percent at 57-63 days gestation. Thus, as the failure rate of RU-486 increases 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 WOMENS 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 abortion providers 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.

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 Womens Health, prepared for the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and

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.

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).

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. FDA Public Health Advisory: Sepsis and Medical Abortion (updated Jan. 27, 2010), available at http://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 Natl Acad. Sci. 86: 2374-78 (1989); Statement by Donna Harrison, M.D., for RU486: Demonstrating a Low Standard for Womens Health?, Hearing before the Committee on Government Reform, House of Representatives (May 17, 2006), Serial No. 109-202, at 135, 138.
7 6

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. Staff Report, supra, at page 25. See Mifeprex Label, supra. Id. Id. Id. Id. Id. Id. Id. Id. Id. Id.

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Id. Id. Id. Id. Id.

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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.sjr.com/health/x576519774/Local-Planned-Parenthood-to-offer-abortion-drugs (last visited Jan. 26, 2011).
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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 in Support of Plaintiffs Motion for Temporary Injunction, July 18, 2011). 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. 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.

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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).
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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).

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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