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Life | The Abortion Pill (Also Known as RU-486 or Mifeprex)
Overview
In September 2000, the FDA approved the abortion pill RU-486, now known as mifepristone (brand name: Mifeprex), for use as an abortifacient (abortion-inducing drug). RU-486 is approved for use through the first seven weeks of pregnancy.1 RU-486 is different from the “morning-after pill,” also known as “emergency contraception,” which must be taken 72 hours after intercourse to be effective. RU-486 acts by halting the growth of the uterine lining. The preborn baby is then starved of nutrients supplied by the mother's womb. Two days later, the woman takes an ulcer drug, misoprostol (brand name: Cytotec), which has the side effect of starting uterine contractions, in order to expel the dead baby. The FDA has not specifically approved the use of misoprostol for medication abortions, but its use for this purpose is common. Two weeks after taking RU-486, the woman visits the doctor or clinic again, this time to make sure that the entire baby was expelled. If it has not been expelled, as in about five percent to eight percent of the cases, a surgical abortion is performed.2 In September 2003, Holly Patterson, an 18-year-old from Livermore, California, went to a local Planned Parenthood office and was given abortion medication to abort her pregnancy. Four days later, she went to an emergency room, bleeding and in extreme pain. Three days after that, she returned to the hospital, once again in a great deal of pain. She died that afternoon. The coroner concluded that she died of septic shock, due to endomyometritis caused by the drug-induced abortion.3 Since Holly Patterson’s death, seven more women have died from infection after taking RU-486.4 In total, evidence shows that as of April 2011, at least 19 deaths in the United States and around the world are linked to RU-486.5 The FDA has received reports that in the U.S. there were 2207 adverse events since the drug was approved in 2000, including 14 deaths and 339 cases of bleeding severe enough to require transfusions.6 Because the FDA readily admits that the adverse effects of most medications are underreported – only about one percent to 10 percent of complications are reported for any given drug – RU-486’s adverse effects are probably dramatically understated.7 Center for Arizona Policy, Inc. grants permission to copy and distribute this publication in its entirety Life | The Abortion Pill
Issue Analysis
Medical Issues
As the manufacturer of the abortion pill explains in its prescribing information: “Nearly all of the women who receive Mifeprex and misoprostol will report adverse reactions, and many can be expected to report more than one such reaction.”8 Some of the problems a woman is likely to experience after taking RU-486 are the following:9 In clinical trials before the drug’s approval, nearly 99 percent of women who received a medication abortion experienced one or more of the above side effects.10 In those trials, about one out of every 14 women using RU-486 experienced bleeding severe enough to require medical attention.11 Since its approval, RU-486 has been implicated in the deaths of 14 American women:  Two died after their respective ectopic pregnancies ruptured.  Eight suffered from a systemic bacterial infection.  The final four from overdose, toxic shock, or other causes. Women who survived faced serious complications like ruptured ectopic pregnancies, systemic infections, and one heart attack after taking abortion medication.12 During Canada’s test of the drug in 2001, a Canadian woman died of septic shock resulting from a clostridium infection.13 More recently, in 2011, a Portuguese girl died of septic shock five days after receiving a medical abortion.14 At least five non-U.S. women have died as a result of taking RU-486.15 What has been touted as a way to give women “more control” and “privacy” in abortions, may have unintended psychological consequences. Women must actually administer the drug to themselves and cannot blame others for doing it “to” them. In addition, many women actually see the preborn child when they abort at home. For them, there is no escaping the conclusion that a human life has ended. Center for Arizona Policy, Inc. grants permission to copy and distribute this publication in its entirety Life | The Abortion Pill
Abby Johnson, former director of a Planned Parenthood clinic in Bryan, Texas, describes her own experience with RU-486 as “agony.” For days, she was “too ill to get out of bed,” suffering from “excruciating” cramping, high fever, and heavy bleeding. It was two weeks before she returned to work, and eight weeks before she “felt recovered enough.”16 For a drug that is used to induce an obviously elective process, the near certainty that a woman will suffer from a number of very unpleasant and possibly deadly effects counter opponents’ claims that RU-486 is a “safer alternative” to surgical abortion. Legal Aspects
The FDA, in its approval of RU-486 and in subsequent revisions to that approval, required special distribution rules for the Mifeprex abortion medication. The manufacturer’s information for physicians explains: “Mifeprex [RU-486] will be supplied only to licensed physicians who sign and return a Prescriber’s Agreement … Mifeprex is a prescription drug, although it will not be available to the public through licensed pharmacies.”17 The label also specifies that Mifeprex should only be prescribed “by physicians who have read and understood the prescribing information.”18 The FDA also placed restrictions on administration of RU-486. It must be provided by or under the supervision of a physician who:19  Can accurately assess how far along the pregnancy is.  Has the ability to provide a surgical abortion if a complication arises or has made arrangements for  Can assure patient access to blood transfusions and resuscitation services.  Has read the prescribing information.  Must notify the manufacturer of hospitalization, transfusion, or other “serious event.” In 2010, Planned Parenthood began using “telemedicine” to dispense RU-486 to women seeking medication abortions in Iowa. 20 Using a camera and a microphone to “chat” via computer, the physician is hundreds of miles away while he watches the woman take her first dose of mifepristone.21 This practice is grossly out of line with the FDA protocols and manufacturer’s instructions for medication abortion and places women at risk with no on-site provider capable of managing complications. Physician oversight in a licensed and regulated clinic setting is imperative to ensure minimal complications and risks to the mother.22 Center for Arizona Policy, Inc. grants permission to copy and distribute this publication in its entirety Life | The Abortion Pill
Arizona Law
Arizona law requires any clinic that dispenses abortion medication to be licensed and meet basic health and safety standards.23 Among those safety standards are the following:24  Staff the clinic with qualified personnel.  Keep the building clean and free of trash, bugs, and rats.  Document and implement procedures for sterilizing equipment. The clinic regulations require that a physician is involved in caring for patients both before and after an abortion, including a medication abortion.25 Arizona law also prohibits physician assistants from prescribing abortion medication26 and prohibits the use of “telemedicine” to administer abortion medication.27 The regulations requiring physician involvement are currently in force but are being challenged in court by the abortion industry.28 Both clinic regulations and physician oversight are crucial for the protection of women using RU-486. Talking Points
 Medication abortions are not a safer alternative to surgical abortions. Nearly every woman who
takes the abortion pill will experience some of the pills’ very serious side effects.  At least 14 women have died from taking the abortion pill in America.
 The abortion pill is not the same as so-called “morning-after pills.” The main differences are that
the “morning-after pill” can only be taken up to 72 hours after intercourse, is available over the
counter, and doesn’t always act as an abortifacient. However, the abortion pill always takes the life of
a preborn child.
Conclusion
The abortion industry has tried to sell RU-486 as a safer alternative to surgical abortion, but responsible medical practitioners know better. In the name of increasing access to abortion, abortion advocates have put the health and safety of women at risk by distributing RU-486 outside of the regulations specified by the FDA and dispensed it via webcam, also known as telemedicine abortion. Center for Arizona Policy, Inc. grants permission to copy and distribute this publication in its entirety Life | The Abortion Pill
October 2011 Center for Arizona Policy, Inc. All rights reserved.
This publication includes summaries of many complex areas of law and is not specific legal advice to any person. Consult an attorney if you
have questions about your specific situation or believe your legal rights have been infringed. This publication is educational in nature
and should not be construed as an effort to aid or hinder any legislation.
1 Mifeprex Medication Guide, Danco Laboratories (June 8, 2011), available at www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf. 2 Id. 3 Marc Kaufman, Death After Abortion Pill Reignites Safety Debate, Wash. Post, Nov. 3, 2003 at A03, available at www.washingtonpost.com/ac2/wp-dyn?pagename=article&contentId=A54782-2003Nov2&notFound=true. 4 Mifeprex Questions and Answers, Food and Drug Administration (Feb. 24, 2010), www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111328.htm (last visited Dec. 1, 2011). 5 Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011, Food and Drug Administration, available at www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf. 6 Id. 7Kevin O’Reilly, Doctors Often Dismiss Side Effect Complaints, Patient Survey Says, Am. Medical News, Oct. 1, 2007, www.ama-assn.org/amednews/2007/10/01/prl21001.htm (last visited Dec. 1, 2011); see also Salynn Boyles, Abortion Drug Adverse Events Reported, WebMD Medical News, Dec. 29, 2005, www.webmd.com/sex/birth-control/news/20051229/abortion-drug-adverse-events-reported (last visited Dec. 1, 2011). 8 Mifeprex (mifepristone) Prescribing Information, Danco Laboratories (July 2005), available at www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf. 9 Id. 10 Food and Drug Administration, Medical Officer’s Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion Up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Comments 11 (Nov. 22, 1999), available at www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_Mifepristone_medr_P1.pdf. 11 Id. at 13. 12 Postmarketing Report, supra note 5. 13 Wendy McLellan, Canadian trial to evaluate abortion pill RU-486 on hold after woman dies, Canadian Press Newswire, Sept. 19, 2001. 14 Portugal: Girl Dies of Septic Shock from RU-486 Pill, ANSAmed, May 12, 2011, http://ansamed.biz/en/scienza/news/ME.XEF27979.html (last visited Dec. 1, 2011). 15 Postmarketing Report, supra note 5. 16 Abby Johnson, Unplanned 47-48 (2010). 17 Mifeprex (mifepristone) Prescribing Information, supra note 8. 18 Id. 19 Id.; Mifeprex Medication Guide, supra note 1. 20 Monica Davey, Abortion Drugs Given in Iowa via Video Link, N.Y. Times, June 8, 2010 at A1, available at www.nytimes.com/2010/06/09/health/policy/09video.html. 21 Id. 22 Letter from Allan T. Sawyer to Arizona House Health and Human Services Committee, available at www.azvoterguide.com/wp-content/uploads/2011/02/2011-02-01-Sawyer-Medical-Abortion-Testimony.pdf. 23 Ariz. Rev. Stat. §§ 36-449.02 and 36-449.03. 24 Ariz. Admin. Code §§ R9-10-1501 through 1514, available at www.azdhs.gov/als/medical/pdf/abortion_unoffic_rules.pdf. 25 See, e.g., id. at R9-10-1508(A)(2). 26 Ariz. Rev. Stat. § 32-2532. 27 Ariz. Rev. Stat. § 36-3604. 28 Planned Parenthood v. Horne, CV 2010-03230. Center for Arizona Policy, Inc. grants permission to copy and distribute this publication in its entirety

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