FDA Update Reveals 14 Deaths from RU486, 2,209 “Adverse Events”

By Dave Andrusko

Randall K. O'Bannon, Ph.D.

“These latest deaths tell us that, despite all the investigations, all the warnings, all the assurances, women taking RU486 and its accompanying prostaglandin misoprostol are still dying.”
          — Dr. Randall K. O’Bannon, NRL Director of Education, from “The Story Behind Two New RU486 Patient Deaths,” October 14, 2010.


National Right to Life has tracked the trail of the two-drug RU486 abortion technique (mifepristone and misoprostol) since well before it was approved for use in the United States by Bill Clinton’s FDA in 2000. We said then and repeated ever since that for a myriad of reasons, this “easy,” “safe” abortion procedure not only is lethal to unborn babies but also risky to their mothers.

What we learned from the beginning was reaffirmed this week: you have to be on the lookout constantly for what are euphemistically labeled “adverse events.” Well, with zero publicity, the FDA released a report, dated April 30, under the benign headline   “Post-Marketing Adverse Events in U.S. Women Who Used Mifepristone for Termination of Pregnancy.” (Dr. O’Bannon will write a more detailed analysis for National Right to Life News Today on Friday.)

In the United States alone, 14 women have died since September 2000 while another 612 were hospitalized. As Dr. O’Bannon has warned repeatedly , there were 339 cases in which blood loss was serious enough to require transfusions, according to the FDA.

The FDA reports 256 cases under the category “infections.” In the accompanying footnote, we learn this includes very serious stuff– endometritis, pelvic inflammatory disease, and pelvic infections with sepsis (“a serious systemic infection that has spread beyond the reproductive organs”).

But 48 of these were labeled “severe infections.” The footnote explains that “severe infections generally involve death or hospital for at least 2-3 days, intravenous antibiotics for at least 24 hours, total antibiotic usage for at least 3 days, and any other physical or clinical findings, laboratory data or surgery that suggests a severe infection.”

Overall there were 2,207 “cases with any adverse event.”  Those included 58 ectopic pregnancies which are extremely dangerous.

The signs of a ruptured ectopic pregnancy are disturbingly similar to expected side effects of a chemical abortion — bleeding and painful cramping in the lower abdomen.  RU486 doesn’t abort ectopic pregnancies, but a woman with an undiscovered ectopic pregnancy who takes the drug may think she’s aborting when she’s actually undergoing the rupture, and she may not get help in time

Two other important considerations. First, although you would never know it by accounts in the press, complications are not infrequently associated with mifepristone (“RU486”) and the accompanying prostaglandin misoprostol.

In May we ran a story headlined ”New Study Undermines Case for RU486 in Australia” (www.nationalrighttolifenews.org/news/2011/05/new-study-undermines-case-for-ru486-in-australia/). The first two sentences of a story summarizing a study from the Australian Family Physician are very important:

“The ‘audit’ [study] of nearly 7000 abortions performed in South Australia in 2009 and last year found that 3.3 per cent of women who used mifepristone  in the first trimester of pregnancy–when most elective terminations occur – later turned up at hospital emergency departments, against 2.2 per cent who had undergone surgery.

“And the rate of hospital admission jumped to 5.7 per cent for recipients of early ‘medical’ abortions –using drugs–compared with 0.4 per cent for surgical patients re-admitted for post-operative treatment.”

National Right to Life News has run many, many stories about complications associated with the use of RU486. For example, a 2009 study from Finland found that 20% of the women using the abortion pill suffer at least one significant complication and that nearly 4% reported two or more complications or “adverse events” (see www.nrlc.org/news/2009/NRL11-12/RU486.html).

Second, there are more and more and more RU486 abortions taking place in the United States.

The number of chemical abortions has swollen even as the overall number of abortions has stabilized. The Guttmacher Institute said that chemical abortions (almost all of which are RU486 abortions) jumped from 70,500 in 2001 to 199,000 in 2008.

This latest report from the FDA puts the number of women who have used RU486 in the U.S. at 1.52 million.

From Guttmacher, which started out as a research affiliate for Planned Parenthood, we can see that while there has been a 25% decrease in abortion providers from 1992 to 2008, the number of providers who dispense the abortion pills has increased from about 600 in 2001 to 1,066 in 2008.

As we’ve reported many times, Planned Parenthood is in the midst of a massive consolidation of its own clinics (weeding out the less-profitable) while at the same time absorbing smaller independent clinics, all in search of fattening its already hefty bottom line. A key ingredient in extending its reach into rural areas is “webcam” abortions which utilize RU486.

The danger is doubled for women: the use of RU 486 in a situation where she can be hundreds of miles away from the abortionist who is “counseling” her (and releasing the RU486) by means of a video conferencing system.

We will return to the topic  Friday. Suffice it to say that with hundreds of chemical abortion patients having ended up hospitalized with hemorrhages, ruptured ectopic pregnancies, or serious infections, and at least 14 deaths, it is important to stop wider use of RU486.   

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