Despite the well-documented risks associated with the use of the abortion pill, Planned Parenthood, the largest and most lucrative abortion chain in the United States, continues to promote the drug as a safe and effective method of termination. The National Abortion Federation, a professional organization representing abortion providers, has also endorsed the safety of chemical abortions, stating that they have an “excellent safety profile.” Danco, the U.S. distributor of the abortion pill, asserts that it is a “safe and effective option.”
Upon examination of their materials, it becomes evident that the chemical abortifacients in question are not universally effective and that a certain percentage of users experience complications. However, the clear message that emerges is that the chemical abortifacients have been used safely by millions of women worldwide (NAF, Factsheet, “What is Medical Abortion?” 9/06).
However, a visit to the Food & Drug Administration (FDA) website presents a markedly different picture. To ensure clarity, it is important to note that “RU486” refers to a two-drug abortion technique: mifepristone, which is the generic name (sold under the trade name Mifeprex), and the accompanying prostaglandin, misoprostol, which expels the dead baby.
The page is titled “Mifeprex (mifepristone) Information.” You find it at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm
The link to the latest report on “adverse events” can be found at the bottom of the FDA page. This link was added at the request of Senator Orrin Hatch. The report includes information on the 14 U.S. women and five women from other countries who have died after taking the drugs. It also includes statistical information on the 2,207 women who have been reported for complications such as infections, hemorrhage, and ectopic pregnancies.
In the 7/14/11 and 7/16/11 editions of NRL News Today, we presented a detailed analysis of the latest adverse events report. However, the admissions found on the “Mifeprex (mifepristone) Information” page offer a wealth of additional insights.
The first paragraph of the FDA report notes that since its approval in September 2000, the Food and Drug Administration has received reports of serious adverse events, including several deaths, in the United States following medical abortion with mifepristone and misoprostol. A detailed account of these events can be found in our earlier publications, including our fact sheet on deaths associated with RU-486.
The U.S. Food and Drug Administration (FDA) has noted that several women who died in the United States following medical abortion with mifepristone and misoprostol died from sepsis, a severe illness caused by infection of the bloodstream. Although the FDA acknowledges that “sepsis is a known risk related to any type of abortion,” it notes that many of these women were infected with bacteria (Clostridium sordellii) that did not present the typical symptoms of sepsis.
These infections are accompanied by abdominal discomfort, weakness, nausea, vomiting, and diarrhea, which are all common side effects of chemical abortions. However, it is noteworthy that these symptoms may occur in the absence of a fever.
Websites associated with Danco and Planned Parenthood, one of the nation’s largest promoters and providers of chemical abortions, mention a fever of 100.4°F as a possible symptom of infection. However, they do not advise women that these infections can occur without a fever. For further information, please visit earlyoptionpill.com/section/safety-information. For further information on the abortion pill, please refer to the following website: www.plannedparenthood.org/health-topics/abortion/abortion-pill-medication-abortion-4354.asp.
The National Abortion Federation (NAF) does advise women who experience “the onset of severe abdominal pain, malaise, or ‘feeling sick,’ even in the absence of fever,” more than 24 hours after taking misoprostol, to “contact the facility that provided the abortion.” However, NAF does not elucidate the relationship between these symptoms and the deadly infections that have resulted in the deaths of eight U.S. women (NAF Factsheet, “Safety of Abortion,” 12/06).
In point of fact, the Centers for Disease Control and Prevention (CDC) fact sheet states that the medications in question have been found to have no causal link with the incidents of infection in question. Furthermore, the CDC asserts that this type of fatal infection has also been observed to occur following miscarriage, childbirth and surgical abortion, as well as other contexts unrelated to pregnancy.
Although technically accurate, this assertion is misleading and irresponsible. While there have been a few cases of Clostridium sordellii infections among women giving birth or miscarrying over the past several decades, these occurrences have been extremely rare. In contrast, the sudden concentration of infection deaths among this much smaller population of women aborting with RU486 is noteworthy.
Although the precise causal chain that led to the fatal infections in the women studied by the CDC remains unclear, several researchers who presented at the conference and have published journal articles on the subject have noted that both mifepristone and misoprostol may suppress a woman’s immune system, leaving her particularly vulnerable to this rare infection. The off-label use of misoprostol (i.e., the administration of the medication by the woman herself, rather than by mouth, as recommended by the FDA) has also been proposed as a potential explanation for the observed link. For further details on the joint CDC/FDA conference that investigated these infection deaths in 2006, please refer to the May 2006 NRL News.
For several years, Planned Parenthood recommended the use of vaginal misoprostol in conjunction with a protocol that included this medication. This recommendation was made while both NAF and Danco continued to list the vaginal misoprostol regimen as an alternative treatment option as of July 2011. Following the deaths of two patients at Planned Parenthood facilities due to Clostridial infections, the organization ceased the use of vaginal misoprostol and initiated the administration of prophylactic antibiotics. This change in treatment approach appeared to result in a reduction in infection rates.
The FDA has issued a cautionary statement on its information page regarding the use of prophylactic antibiotics during medical abortions. The FDA has determined that there is currently an insufficient body of evidence to recommend the use of prophylactic antibiotics for women undergoing medical abortions. The FDA has also issued a warning regarding the potential risks associated with prophylactic antibiotic use. These risks include the possibility of developing severe or fatal allergic reactions and the stimulation of the growth of “superbugs,” bacteria resistant to everyday antibiotics.
In other words, Planned Parenthood may be obtaining short-term gain for a few women at the expense of others in the future, who will present with antibiotic-resistant infections that will not be treatable with the antibiotics currently in use.
Despite the Food and Drug Administration (FDA) protocol, Planned Parenthood and numerous other abortion providers continue to deviate from the protocol in a number of ways. These include reducing the dosage of the more expensive mifepristone (approximately $90 per pill) from three pills to one, doubling the dosage of the cheaper misoprostol, and offering abortions to women up to 63 days after their last menstrual period. (“Rates of Serious Infection after Changes in Regimens for Medical Abortion,” which appeared in the New England Journal of Medicine on July 9, 2009.)
The FDA approved use up to 49 days LMP.
The FDA additionally notes that the safety and efficacy of alternative Mifeprex dosing regimens, including the use of oral misoprostol tablets vaginally, have not been established by the FDA.
The published results of the U.S. trial of RU486 indicated that the effectiveness of the drug declined significantly after 49 days, with the efficacy dropping from 92% to 83% at 56 days LMP and further to 77% at 63 days LMP (New England Journal of Medicine, 4/30/98).
Planned Parenthood and NAF have presented studies indicating an effectiveness rate of 97-98% at 63 days with altered doses. However, these higher rates appear to be based, at least in part, on studies employing vaginal misoprostol (see American College of Obstetricians and Gynecologists, “ACOG Practice Bulletin: A practice that has come under scrutiny is the use of misoprostol in medical abortion, as evidenced by the 2005 Clinical Management Guidelines on Medical Management of Abortion in Obstetrics & Gynecology and the 2008 NAF Factsheet, “What Is Medical Abortion.”
It is estimated that over 1.5 million children have died as a result of the use of chemical abortions in the United States. In order to achieve this result, the abortion industry has been willing to expose women to significant medical risk, with 19 deaths and hundreds more hospitalisations.
They modify the protocol, yet persist in promoting the product. Inevitably, more individuals will perish. Regrettably, more will perish.
Daniel Miller is responsible for nearly all of National Right to Life News' political writing.
With the election of Donald Trump to the U.S. presidency, Daniel Miller developed a deep obsession with U.S. politics that has never let go of the political scientist. Whether it's the election of Joe Biden, the midterm elections in Congress, the abortion rights debate in the Supreme Court or the mudslinging in the primaries - Daniel Miller is happy to stay up late for you.
Daniel was born and raised in New York. After living in China, working for a news agency and another stint at a major news network, he now lives in Arizona with his two daughters.
