Eight.  That’s the number of women who have died from a severe bacterial infection following use of RU-486 (also known as Mifeprex).  In all eight cases, the women were instructed to use the abortion drugs in a way that has not been approved by the FDA.[1]

Zero.  That’s the number of women who have died from a severe bacterial infection after using RU-486 in the way approved by the FDA.

And yet all over the country, Planned Parenthood clinics instruct women to use RU-486 in a way that is not deemed safe by the FDA. 

Moreover, Planned Parenthood is going out of its way to make sure it can continue this misuse.  For example, since 2004, the abortion giant has been fighting an Ohio law that requires it to follow FDA guidelines when administering RU-486. 

And most recently, Planned Parenthood collaborated with the pro-abortion American College of Obstetricians & Gynecologists (ACOG) to publish a “study” purportedly showing that the unapproved use of RU-486 is “safe” for women.  Yet, an important fact—missed by some—completely undercuts Planned Parenthood’s intended conclusion: the ACOG study did not differentiate between patients who have used the drugs according to the FDA protocol and those who have been instructed to use the drugs in an unapproved manner.

In order to fully understand the many flaws in this study, a little background is in order.  The standard method of chemical  abortion in the United States is the combined use of mifepristone and misoprostol.  Together, mifepristone and misoprostol make up the drug regimen people commonly refer to as “RU-486.”

When the FDA approved RU-486, it did so under a special code section that is used for drugs that “can be safely used only if distribution or use is restricted.”[2]  In other words, the FDA recognized the danger inherent RU-486 and approved it with restrictions on use.[3] 

The drug label required by the FDA includes the following statements:

  • Treatment with [mifepristone] and misoprostol for the termination of pregnancy requires three office visits by the patient.
  • [RU-486] should be prescribed only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.
  • Mifepristone [the first drug in the RU-486 regimen] is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.
  • Day One: Three 200 mg tablets (600 mg) of [mifepristone] are taken in a single dose.
  • Day Three: The patient returns to the health care provider two days after ingesting [mifepristone].  Unless abortion has occurred … the patient takes two 200 µg tables (400 µg) of misoprostol orally.[4]

So in sum, the FDA-approved protocol for the administration of RU-486 includes three office visits.  The drugs are to be administered at the clinic and at least under the supervision (if not in the presence) of a physician.  The drugs are to be used only until 49 days gestation, and they are to be administered orally.

However, Planned Parenthood does not follow this protocol and instead uses its own protocol for administration.  Instead of following the FDA’s 49-day restriction, Planned Parenthood offers RU-486 through 63 days gestation.  Instead of administering RU-486 in a clinic or office setting, Planned Parenthood sends women away to take the second dose (misoprostol) at home and potentially alone.  And instead of instructing women to take misoprostol orally—as instructed in the label—Planned Parenthood instructs women to take misoprostol buccally (allowed to dissolve in the mouth). 

At least one woman has died from bacterial infection following buccal use of misoprostol.  And yet this is the unapproved use of RU-486 that Planned Parenthood is fighting for.  The need for protective legislation restricting the administration of RU-486 to the manner approved by the FDA could not be more clear.

And now Planned Parenthood is on the defense.  In 2012, the Sixth Circuit Court of Appeals upheld Ohio’s law requiring physicians to administer RU-486 according to the FDA-approved protocol.  Other states have passed or are considering similar legislation. 

And Planned Parenthood is scrambling, trying to keep the public from realizing the truth about its dangerous use of RU-486.  In what appears to be a direct response to the success of AUL’s educational and legislative campaign on the need for strict regulations on the administration of RU-486, Planned Parenthood released the ACOG study in late 2012.  This study, as referenced above, is full of flaws.

Flaw: The study does not make any distinctions between misuse and FDA-approved use of RU-486

The authors of the study claim that their “evidence” does not support legislation “restricting abortion providers to use of the FDA-approved regimen.”  But nowhere in the study do the authors compare the rates of complications between women who misuse the drug and those who use the drug according to the FDA-approved protocol.  Instead, all adverse events are grouped together.

For example, the authors report that, in 2010, there were 23 cases of infection following a medical abortion.  But the question remains: how many of these 23 women used the FDA-approved protocol, and how many were instructed to misuse the drugs? 

This study simply cannot be used to make a safety comparison between misuse of RU-486 and the FDA-approved protocol.  It is possible that all 23 women who reportedly suffered from infection following RU-486 abortions at Planned Parenthood used the drugs in a manner not approved by the FDA. 

Flaw: The study did not take gestational age into account

One of the provisions in the FDA-approved protocol limits use of RU-486 through 49 days gestation.   As gestational age increases, RU-486 becomes less effective and potentially more dangerous.  However, the study’s authors did not analyze the reported complications according to gestational age.  It is possible that most or all of the complications reported occurred outside the 49-day time limit approved by the FDA.  Without knowing, it is impossible to say that Planned Parenthood’s misuse of RU-486 (past 49 days gestation) is safer than the 49-day FDA-approved limit.

Flaw: The study did not include information on all patients who had incomplete abortions following use of RU-486

One recognized complication of RU-486 is the “failure” of the drugs to actually terminate the pregnancy.  The authors of the ACOG study set out to show that RU-486 has a low failure rate.  While the authors report that the “most common significant outcome was ongoing intrauterine pregnancy,” they conclude that the outcome only occurred in 1,158 cases (in 2009 and 2010)—or 0.5 percent of the cases.

However, the authors report that Planned Parenthood’s Manual of Medical Standards calls for a repeat chemical abortion if the first abortion does not terminate pregnancy.  So if RU-486 fails to terminate a woman’s pregnancy, she is given another round of RU-486 (i.e., two chemical  abortions). 

But the number reported by the study’s authors— 1,158 women—does not include women who were given repeat rounds of RU-486.  Thus, the number of women who experienced an incomplete abortion following the use of RU-486 is actually higher than that reported by the authors.

Flaw: Only complications treated at Planned Parenthood clinics were considered

Because the ACOG study only included reports of complications that were treated by Planned Parenthood clinics, it does not include any complications treated by an emergency room or physician unaffiliated with Planned Parenthood.  For example, a woman who experienced severe bleeding following an RU-486 abortion and treated by emergency room personnel was not be included in the study.

The study also failed to include any women who did not report back for follow-up appointments.  Any complications faced by those women are not included.

The study is, therefore, inherently under-inclusive and does not provide an accurate accounting of the number of complications arising after RU-486 abortions.

Flaw: The FDA does not encourage off-label use of RU-486

The study claims that the FDA “allows and encourages” off-label use of drugs.  That might be true with most drugs.  But RU-486 is not in a category with most drugs.  Unlike most drugs, it was approved with restrictions.  Leading a woman to believe that the FDA allows and encourages off-label use of RU-486 is disingenuous—and potentially dangerous.

Flaw: Studying “efficacy” of a drug does not mean that it is safe

One point raised by the study’s authors is that the “efficacy” rate of the FDA-approved regimen is lower than the efficacy rate of off-label regimens.  However, efficacy should not be confused with safety.  Simply because a drug regimen is more effective at terminating a pregnancy does not mean that it is safer.

Instead, the study shows that, in 2009 and 2010, Planned Parenthood provided 233,805 chemical abortions.  “Significant adverse events or outcomes were reported in 1,530 cases.”  That means more than two women each day faced a “significant adverse event or outcome” following chemical abortions.

On the other hand, studies have shown that surgical abortion is a safer alternative.  For example, one study has shown that women are more likely to be admitted and require surgical intervention after first-trimester chemical abortions than following surgical abortions.[5]  Another study revealed that the overall incidence of immediate adverse events is fourfold higher for chemical abortions than for surgical abortions.[6]  In particular, hemorrhage and incomplete abortion (or failed abortion) are more common after chemical abortions.[7] 

And, significant here, there is also a greater risk of severe infection following chemical abortion than following surgical abortion.[8] 

[1] FDA, Mifepristone U.S. Postmarketing Adverse Events Summary Through 04/30/11 (July 2011), available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf (last visited Jan. 7, 2013).

[2] 21 C.F.R. § 314.520.

[3] FDA, Sept. 2000 Approval Letter.

[4] Mifeprex Final Printed Labeling (FPL), available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf (last visited Jan. 4, 2013).

[5] E. Mulligan & H. Messenger, Mifepristone in South Australia: The First 1343 Tablets, Australian Family Physician 40(5):342, 344 (May 2011).

[6] M. Niinimaki et al., Immediate Complications after Medical compared with Surgical Termination of Pregnancy, Obstet. Gynecol. 114:795 (Oct. 2009).

[7] Id.

[8] See M. Fisher et al., Fatal Toxic Shock Syndrome Associated with Clostridium sordelli after Medical Abortion, N.E. J.M. 353:2352-60 (2005); M. Greene, Fatal Infections Associated with Mifepristone-Induced Abortion, N.E.J.M. 353:2317-18 (2005).