In consultation with the American Association of Pro-Life OB/GYNs, Live Action has published a comprehensive and well-documented report entitled Abortion Pill Exposed. The report includes the developmental and legal history of RU-486, how it works, its adverse effects, who has supported its development and is “pushing to deregulate” it, and the legislation passed to protect the preborn and their mothers from its effects. This article summarizes some of these topics. You can read and download the entire report at liveaction.org/abortion-pill-kills.
The government’s role
The Food and Drug Administration exercises some control over the use of the abortion pill(s). One way is its Risk Evaluation and Mitigation Strategy, which governs some 74 drugs (of the thousands in use), their use, and safety. The pro-abortion movement would like to get the abortion pill off the REMS list and have it available over the counter without a prescription. Under previous REMS regulations, the abortion pill Mifeprex (a.k.a. mifepristone) can only be dispensed under the supervision of a clinician who is certified to prescribe it, and it must be dispensed in clinics, medical offices, or hospitals. The clinician is expected to supervise the patient, who must sign an FDA agreement establishing informed consent regarding the pills’ risks. According to Abortion Pill Exposed, these risks include possible “excruciating abdominal pain, weeks of heavy bleeding, nausea, vomiting, diarrhea, headache, infection, sepsis and in some cases, death.”1
The report also states that the FDA maintains an Adverse Event Reporting System (FAERS) for the abortion pill and other drugs. Between 2000 and 2018, 24 deaths involving the pill were reported, as well as over 1,000 hospitalizations and 4,195 adverse events attributed to its use. However, these events are underreported, since reporting by both consumers and healthcare professionals is voluntary.
Live Action’s report notes that “a recent study by the Institute for Safe Medicine Practices found that FAERS data may only reflect about 1% of all adverse events associated with FDA-approved drugs, devices, and products.”2 Moreover, abortion providers often tell women to go to an emergency room if they are having difficulty and report only that they are having a miscarriage.
Medical literature review
We reviewed eight studies in the medical literature published between 2001 and 2018 involving over 83,000 women in the US and two Scandinavian countries (which keep excellent records) contrasting the results of medical (pill) abortion versus surgical abortions at 63 days gestation or less. The main complications reported were hemorrhage and incomplete abortion, often requiring subsequent surgical abortion.3 Although the overall complication rates for both groups were relatively low, the rates for pill abortions varied from 2.0 percent to 7.5 percent higher than surgical abortions.
One of the studies, which considered 3,696 medical abortions in Sweden done at less than 12 weeks, noted that the rate of complications increased over time from 4.2 percent in 2008 to 8.2 percent in 2015 and suggested that the increase may be associated with the shift from hospital to home abortions.4 Two other studies concluded that the likelihood of complications increased as the preborn’s gestational age increased, and a third noted that the complication rate increased as the women’s parity increased.
We also reviewed five studies published from 2008 through spring 2021 that investigated only pill abortions.5 Four of the studies involved a combined total of 22,894 women in the US, while the fifth was a meta-analysis of 54 studies involving both US women and those from other countries. Two of the studies with similar methodology and a combined total of 1,064 cases had failure rates for pill abortions varying from 6.3 percent to seven percent. A third study contrasted 10,405 clinic in-person pill abortions with 8,765 telemed abortions. Its measure of success or failure involved a survey of 119 hospital emergency departments in Iowa, with only 35 percent responding. This yielded only 33 “adverse events” (complications) from the in-person group and 16 from the telemed group.6 Given the low response rate of the emergency departments and the fact that adverse events are underreported, the representativeness of these results is questionable.
The fourth study analyzed 2,660 US adverse event reports to the FDA’s FAERS database from September 2000 to February 2019 that had not been covered in earlier studies. Of these pill abortions, 20 resulted in deaths, 529 were rated as life-threatening, 1,957 as severe, 151 as moderate, and three as mild. The authors note that “retained products of conception and hemorrhage caused most morbidity” resulting in 2,243 surgeries. The study also noted that 75 ectopic pregnancies were discovered, 26 (34.7 percent) of which had ruptured.7
The major finding of the meta-analysis of 54 studies was that the success of pill abortions decreases with increasing gestational age. Thus, “incomplete abortions” varied from 2-4 percent at gestational age 49 days or less, 5-8 percent at age 50 days, and 9-22 percent at 57 days or over.8
Women as patient-abortionists
On April 12, 2021, the Biden administration’s acting FDA commissioner, Janet Woodcock, declared it safe to allow mifepristone (RU-486) to be taken at home without medical supervision, thereby reversing the Trump administration’s ban on mailing abortion-inducing drugs by mail.9 Thus, abortion advocates, who said abortion was a private matter between “a woman and her doctor,” now want her to be both woman and doctor. Further, as the Live Action report notes, she must now fill the roles of patient, prescriber, diagnostician, and counselor.
As a patient concerned about her own welfare, the woman should know the normal risks of taking the pill as described in the second paragraph of this article.
As a prescriber, the woman should know the contraindications for taking the abortion pill, which include certain medications, taking coagulants, problems with her adrenal glands, and having an IUD in place.10
As a diagnostician, the woman must accurately diagnose how many weeks she has been pregnant, how much bleeding is too much bleeding, and whether or not the abortion has totally emptied her womb. Her self-diagnosis should also determine if her pregnancy is ectopic (which requires an ultrasound), since it will not be affected by the pill. She should be aware of the fact that ruptured ectopic pregnancies are a leading cause of maternal death. And finally, she should know whether she is Rh positive or negative and take appropriate action so as not to endanger the lives of future wanted children.
As a counselor, the woman must be prepared to deal with the possible trauma of viewing the stark results of her decision, since no clinic staff will be there to shield her from them.
Evidence from several recent state reports suggests that women who undergo medical abortions at home may have a very difficult time. For example, the Arkansas Department of Health reported that, in 2019, while medical abortions made up 55 percent of abortions, they accounted for 89 percent of complications. In Pennsylvania, the corresponding figures were 45 percent of abortions and 60 percent of complications, and in Texas, medical abortions accounted for 48.5 percent of complications. Finally, a large study of Medicaid records in California found that medical abortions had a complication rate four times that of surgical abortions.11
Women should also realize that mail-order or over-the-counter abortifacients make it easier for sex traffickers, abusers, disgruntled boyfriends, and phony pill merchants to take advantage of them. Finally, parents should realize that their underage daughters may also have access to the pill.
Pro-life response: Medical
In 2018, Dr. George Delgado and a team of medical and academic researchers published a study in Issues in Law and Medicine.12 Recognizing that the natural hormone progesterone was significant in preparing a woman’s womb to receive a fertilized egg and in maintaining the pregnancy, they studied the outcomes of 547 women who had changed their minds about aborting after taking mifepristone (Mifeprex) and who were given progesterone before taking the second pill (misoprostol), which causes the womb to contract and empty. The abortion process was stopped, resulting in 257 births. Higher reversal rates of 64 to 68 percent were observed for two subgroups that received higher doses of progesterone. Reversal success was not affected by maternal age and occurred up to 72 hours after the first abortion pill was ingested. Finally, the authors found no increased risk of birth defects or preterm births because of the reversal procedure.
As a result of their work, an abortion pill reversal network was established and is now coordinated by Heartbeat International, headquartered in Columbus, Ohio. According to HI, women wanting to reverse a chemical abortion should call 877-558-0333 as soon as possible—and no later than 72 hours—after taking the first abortion pill. They will be put in touch with one of over 1,000 medical professionals across the country. HI estimates that, in 2020, there were 763 “rescues” (saves) representing 65 percent of the 1,174 “starts” of the reversal process.13 Thus, besides the nation’s mobile ultrasound vans, pregnancy help centers, and sidewalk counselors, another action-oriented pro-life group is available to assist women with surprise pregnancies.
Pro-life response: Legal
The Guttmacher Institute reports that, as of December 1, 2021, 32 states require clinicians who administer medication abortions to be a physician. Nineteen states also require the clinician to be physically present when the medication is administered, thereby prohibiting the use of telemedicine.14
All of these laws, it would seem, are weakened/negated by the Biden administration’s April 12, 2021, order to permit mifepristone to be mailed. Heartbeat International, however, reports that 10 states have passed laws requiring women considering medical abortion to be provided information about the possibility of medical abortion reversal.
Finally, we note that, rather than “empowering women”—as pro-abortion advocates argue—self-induced pill abortions not only kill preborn children but further magnify women’s experiences as victims.
1. Abortion Pill Exposed, Live Action in consultation with the American Association of Pro-Life OB/GYNs, accessed December 6, 2021, liveaction.org/abortion-pill-kills.
2. Ibid.
3. Child, T. J., Thomas, J. et al., “A Comparative Study of Surgical and Medical Procedures: 932 Pregnancy Terminations Up to 63 Days Gestation,” Human Reproduction (January 2001) 16 (1): 67, academic.oup.com/humrep/article/16/1/67/3113907; Say, Lale, et al., “Medical Versus Surgical Methods for First Trimester Termination of Pregnancy,” Cochrane Fertility Regulation Group (October 21, 2002): 1, cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003037.pub2/full; Niinimaki, Maarit, et al., “Immediate Complications after Medical Compared with Surgical Termination of Pregnancy,” Obstetrics & Gynecology (October 2009): 114(4): 795-804, journals.lww.com/greenjournal/Abstract/2009/10000/Immediate_Complications_After_Medical_Compared.14.aspx; Bennett, Ian M., Baylson, et al., “Early Abortion in Family Medicine: Clinical Outcomes,” Annals of Family Medicine, (Nov.-Dec. 2009): (6): 527-533, ncbi.nlm.nih.gov/pmc/articles/PMC2775627; Grossman, Daniel A., Kate Grindlay, et al., “Changes in Service Delivery Patterns after Introduction of Telemedicine Provision of Medical Abortion in Iowa,” American Journal of Public Health, (January 2013): 103 (1):73-78, ncbi.nlm.nih.gov/pmc/articles/PMC3518368. See critique of the earlier electronic version of this study by Jacqueline Harvey, “Study: Telemed Abortions Increase Complications for Women,” LifeNews.com, December 26, 2012; Upadhyay, Ushma D., et al. “Incidence of Emergency Department Visits and Complications after Abortion,” Obstetrics & Gynecology (January 2015): 125(1): 175-183, journals.lww.com/greenjournal/Fulltext/2015/01000/Incidence_of_Emergency_Department_Visits_and.29.aspx; Ireland, Luu Doan, Gatter, Mary, Chen, Angela Y., “Medical Compared with Surgical Abortion for Effective Pregnancy Termination in the First Trimester,” Obstetrics & Gynecology (July 2015): 126 (1): 22-28; Carlsson, Isabelle, Karin Breding, et al. “Complications Related to Induced Abortion: A Combined Retrospective and Longitudinal Follow-Up Study,” BMC Women’s Health (2018):18: 1-9.
4. Carlsson, Isabelle, Karin Breding, et al. “Complications Related to Induced Abortion: A Combined Retrospective and Longitudinal Follow-Up Study,” BMC Women’s Health (2018):18: 1-9.
5. James G. Kahn, Betsy Jane Becker, et al., “The Efficacy of Medical Abortion: A Meta-Analysis,” Contraception (January 2000): 61 (1):29-40, ncbi.nlm.nih.gov/books/NBK68258; Winikoff, B., Dzuba, I.G., et al., “Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion: A Randomized Control Trial,” Obstetrics & Gynecology (December 2008): 112(6): 1303-1310, journals.lww.com/greenjournal/Abstract/2008/12000/Two_Distinct_Oral_Routes_of_Misoprostol_in.18.aspx; Grossman, Daniel and Kate Grindlay, “Safety of Medical Abortion Provided through Telemedicine Compared with In Person,” Obstetrics & Gynecology (October 2017): 130 (4): 778-782, journals.lww.com/greenjournal/Abstract/2017/10000/Safety_of_Medical_Abortion_Provided_Through.16.aspx; Raymond, Elizabeth, Chong, E., et al. “TelAbortion: Evaluation of a Direct to Patient Telemedicine Abortion Service in the United States,” Contraception 100 (3): 173-177, contraceptionjournal.org/article/S0010-7824(19)30176-3/pdf; Aultman, Kathi, Cirucci, Christina A., et al. “Deaths and Severe Adverse Events after the Use of Mifepristone as an Abortifacient from September 2000 to February 2019,” Issues in Law and Medicine (Spring 2021): 36 (1): 3-26, pubmed.ncbi.nlm.nih.gov/33939340.
6. Grossman, Daniel and Kate Grindlay, “Safety of Medical Abortion Provided through Telemedicine Compared with In Person,” Obstetrics & Gynecology (October 2017): 130 (4): 778-782, journals.lww.com/greenjournal/Abstract/2017/10000/Safety_of_Medical_Abortion_Provided_Through.16.aspx.
7. Aultman, Kathi, Cirucci, Christina A., et al. “Deaths and Severe Adverse Events after the Use of Mifepristone as an Abortifacient from September 2000 to February 2019,” Issues in Law and Medicine (Spring 2021): 36 (1): 3-26, pubmed.ncbi.nlm.nih.gov/33939340.
8. James G. Kahn, Betsy Jane Becker, et al., “The Efficacy of Medical Abortion: A Meta-Analysis,” Contraception(January 2000): 61 (1):29-40, ncbi.nlm.nih.gov/books/NBK68258.
9. Freiburger, Calvin, “Citing COVID-19, Biden FDA Approves Dispensing Abortion Pills through Mail,” LifeSiteNews, April 13, 2021, lifesitenews.com/news/citing-covid-19-biden-fda-approves-dispensing-abortion-pills-through-mail.
10. “Questions and Answers on Mifeprex” Food and Drug Administration, accessed December 6, 2021, fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex.
11. Tessa Longbons, “The Abortion Pill Is Injuring Thousands of Women and the FDA Doesn’t Require Any Reporting,” LifeNews.com, July 8, 2021, lifenews.com/2021/07/08/the-abortion-pill-is-injuring-thousands-of-women-and-the-fda-doesnt-require-any-reporting.
12. Delgado, George, Condly, Steven J. et al., “A Case Series Detailing the Successful Reversal of the Effects of Mifepristone Using Progesterone,” Issues in Law and Medicine (2008) 33 (1): 21-31, google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiHxsX27tD0AhVUkYkEHcjfAZ0QFnoECAQQAQ&url=http%3A%2F%2Fpwhcenters.org%2Fwp-content%2Fuploads%2F2018%2F04%2FABPillReversal_CDM_040618.pdf&usg=AOvVaw0Z1UWUt7h2XFuPRJ9NLE04.
13. Life Trends 2020 Report, Heartbeat International, accessed December 6, 2021, heartbeatinternational.org/lifetrends.
14. “Medication Abortion,” Guttmacher Institute, accessed December 6, 2021, guttmacher.org/state-policy/explore/medication-abortion.
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