What the FDA Website Says about RU486

By Randall K. O’Bannon

Randall K. O'Bannon, Ph.D.

Planned Parenthood, America’s biggest and most lucrative abortion chain, is still telling women that RU486 chemical abortions are “highly safe, highly effective” (NPR, 1/24/11).  The National Abortion Federation declares that chemical abortions “have an excellent safety profile” (NAF, Factsheet, “Safety of Abortion,” 12/06).  Danco, the U.S. distributor of the abortion pill, calls it a “safe, effective option.” 

Read far enough on any of their materials and you’ll find that, yes, it doesn’t work for everyone and that a certain percentage experience complications. But overall, you’ll get the clear message that the chemical abortifacients have “been used safely by millions of women worldwide” (NAF, Factsheet, “What is Medical Abortion?” 9/06).

However that’s a far different picture than one gets with a visit to the Food & Drug Administration (FDA) website. (To get the terminology straight, “RU486” actually 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

Toward the bottom of the FDA page, you’ll find the link to the latest report on “adverse events.” (It is on the FDA page thanks to a request from Sen. Orrin Hatch.) 

These adverse events include the 14 U.S. women and five from other countries known to have died after taking the drugs, along with some statistical information on the 2,207 women who have been reported for complications like infections, hemorrhage, and ectopic pregnancies (www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf).

We wrote on that latest adverse events report in the 7/14/11 and 7/16/11 editions of NRL News Today.  But the admissions found on the “Mifeprex (mifepristone) Information” page offer fascinating additional insights.

Take the first paragraph. The FDA 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.”  We have detailed some of those events in our earlier stories and our “Deaths associated with RU-486″ factsheet at www.nrlc.org/Factsheets/FS15_pilldanger.pdf

The FDA notes that several of the women who died in the U.S. “died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol.”  Though the FDA says that “Sepsis is a known risk related to any type of abortion,” it points out that many of these women were infected with bacteria (Clostridium sordellii) that did not present “the usual symptoms of sepsis”

These particular infections come with abdominal pain or discomfort, weakness, nausea, vomiting or diarrhea–all which just happen to be expected side effects of chemical abortions.  But–and this is extremely significant from a medical standpoint–these symptoms may occur “without 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, but do not advise women that these infections can occur without a fever. [For Danco, go to earlyoptionpill.com/section/safetyinformation. For Planned Parenthood, see www.plannedparenthood.org/health-topics/abortion/abortion-pill-medication-abortion-4354.asp.] 

The National Abortion Federation does tell women noticing “the onset of severe abdominal pain, malaise, or ‘feeling sick’, even in the absence of fever” more than 24 hours after taking the misoprostol to “contact the facility that provided the abortion.” But NAF never explains how these symptoms are connected to the deadly infections that killed eight U.S. women (NAF Factsheet, “Safety of Abortion,” 12/06). 

In fact, its factsheet counsels that the Centers for Disease Control and Prevention (CDC) “have found no causal link between the medications and these incidents of infection and 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.” 

While technically true, this is grossly misleading and irresponsible.   While over the past several decades, there have been a handful of Clostridium sordellii infections among women giving birth or miscarrying, these occurrences have been extremely rare, nothing approaching this sudden concentration of infection deaths among this much smaller population of women aborting with RU486

And while CDC researchers did not nail down the precise causal chain that led to the fatal infections in the women it studied, several who spoke at their conference and who have published journal articles on the subject have noted how both mifepristone and misoprostol may suppress a woman’s immune system, leaving her particularly vulnerable to this type of rare infection.  The off label use of misoprostol (having the woman administer it to herself vaginally, instead of by mouth, as the FDA protocol recommends) has also been offered as a possible explanation of the link. (For more details on the joint CDC/FDA conference that looked into these infection deaths in 2006, see the May 2006 NRL News.) 

Planned Parenthood recommended this protocol with vaginal misoprostol for a number of years, while both NAF and Danco were still listing it as an alternative regimen as of July 2011.

One thing Planned Parenthood did after two of its patients died from Clostridial infections was to stop the vaginal misoprostol and start using prophylactic antibiotics.  This appeared to cut down on infection rates.

But the FDA cautions on its information page that the “FDA does not have sufficient information to recommend the use of prophylactic antibiotics for women having a medical abortion.”  The FDA warns that “Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions.  Also, prophylactic use of antibiotics can stimulate 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 whom present antibiotics will not treat.

Planned Parenthood, along with many other abortionists, continue to deviate from the FDA protocol in a number of ways. They include dropping the dose of the more expensive mifepristone ($90 a pill) from three pills to one, doubling the dose of the cheaper misoprostol, and offering the 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 7/9/09.”

The FDA approved use up to 49 days LMP.

The FDA further cautions that “The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA.”

Published results of the U.S. trial of RU486 found that “effectiveness” dropped off considerably after 49 days, going from 92% to 83% at 56 days LMP and then to just 77% at 63 days LMP (New England Journal of Medicine, 4/30/98). 

Planned Parenthood and NAF say that they have studies showing effectiveness of 97-98% at 63 days with the altered doses. But these higher rates appear to be based, at least in part, on studies employing the vaginal misoprostol (see American College of Obstetricians and Gynecologists, “ACOG Practice Bulletin: Clinical Management Guidelines” on “Medical Management of Abortion” in Obstetrics & Gynecology, October 2005 and NAF Factsheet, “What Is Medical Abortion” 12/08), a practice that has come under scrutiny.

More than 1.5 million children have died from the use of chemical abortions in the U.S.   To get that result, the abortion industry has been willing to expose women to significant medical risk, to the point that 19 have died and hundreds more have ended up hospitalized. 

They tinker with the protocol, but keep pushing the product.  More will die. Sadly, more will die.

Your feedback is important to improving National Right to Life News Today. Please send your comments to daveandrusko@gmail.com. If you like, join those who are following me on Twitter at http://twitter.com/daveha

4 Responses to What the FDA Website Says about RU486

  1. good work buddy, i like coming here read this

  2. Firstly, allow my loved ones recognise somebody?utes get throughout this dilemma. Although this is without doubt brand new , simply by no meanstheless quickly immediately after process your site, that intelligence offers broken substantially. Allow us all to contemplate hold of merely one?utes rss or atom to assist maintain in contact in any way probable emails Trustworthy realize however could give it to support followers together with this personalized live affiliates

  3. You’re thus neat! We please don’t suppose There are learn about a product like this kind of earlier than. Consequently good to find a person with a few authentic what it really this kind of issue. realy we appreciate you starting that in place. this web site is one thing that’s wanted via the internet, another person after a little individuality. handy work for carrying interesting things to the internet!

Leave a Reply

Your email address will not be published.