FDA Reports Determining RU-486’s Safety are “Grossly Deficient”

“Adverse Events Reports relied upon by the FDA to monitor mifepristone’s [RU-486’s] postmarking safety are grossly deficient due to extremely poor quality.”

Margaret M Gary, M.D., Donna J Harrison, M.D. “Analysis of Severe Adverse Reactions related to the use of Mifepristone as an Abortifacient”, 40 (2) Annals of Pharmacology 191 (2006)

 “[A] Majority of the AERs [adverse events reports] analyzed do not provide enough information to accurately code the severity of the adverse event in question. The deficiencies were so egregious in some instances as to preclude analysis.”

………

“Adverse Event Reporting systems typically detect only a small proportion of events that actually occur.”

Michael F Mangono, Principal Deputy Inspector General Of the Department Of Health And Human Services, in testimony before the US Senate committee.

Hearing on consumer safety and weight loss supplements before the subcommittee on oversight of gov. Management, restructuring and the District of Columbia, S. Comm on Government Affairs 107th Cong. (2002) (statement, by Michael F Mangono, Principal Duty Inspector General, office of Inspector General,, US Department of Health & Human Services)

 

(Planned Parenthood continues to violate FDA protocol by offering pill abortions to two weeks later than the FDA approved use)

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FDA Report on RU-486 Shows Problems

FDA, report, dated April 30, 2011

14 women in the United States alone have died from using the mifepristone abortion drug and 2,207 women have been injured by it.

Of the women experiencing medical and physical problems resulting from the abortion drug, 612 women required hospitalizations, 339 experienced blood loss significant enough to require a transfusion, 256 experienced infections and 48 women experienced what the FDA labeled as “severe infections.”

“Severe infections generally involve death or hospitalization 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 suggest a severe infection,” the FDA report states.

Women developing infections from usage of the RU 486 abortion drug experienced endometritis (involving the lining of the womb), pelvic inflammatory disease (involving the nearby reproductive organs such as the fallopian tubes or ovaries), and pelvic infections with sepsis (a serious systemic infection that has spread beyond the reproductive organs).

The FDA figures also reveal that abortion businesses like Planned Parenthood are still misusing the abortion drug.

Despite the FDA indicating, “Administration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy (a pregnancy outside the uterus,” the abortion drug was given to women in 58 cases where they had an ectopic pregnancy.

Report: http://downloads.frc.org/EF/EF11G29.pdf

by Steven Ertelt “New FDA Report: Abortion Drug Kills 14 Women, Injures 2,200”  LifeNews.com | 7/12/11 3:02 PM

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Institute on Women and Technology Rejects Abortion Pill

Bernard Nathanson, MD, recounts:

“The Institute on Women and Technology is an organization dedicated to analyzing the effects of new and existing technologies on women, bringing a feminist perspective the public policy on specific technology and technology-based issues, and advocating technologies that empower women and sustain the natural world.”

They examined the safety of RU-486 before it was put on the market. From their conclusion:

“No procedure requiring strict medical supervision and involving a host of risks and complications will help provide sexual and reproductive self-determination for women.”

They were against the use of the pill.

Nathanson, Bernard N, M.D The Hand of God: a Journey from Death to Life by the Abortion Doctor Who Changed His Mind (Washington DC: Regnery Publishing Inc, 1996) 98-99

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Complications from RU-486 Clinical Trials

When the RU-486 clinical trials were being conducted, it was said that the drug was safe and that there were no adverse reactions in women. However, one doctor tells a different story:

“Dr. Mark Louviere is an emergency room physician in Iowa. He treated a woman in shock from severe blood loss due to an incomplete abortion. Informed that she had been part of the RU-486 clinical trial at Planned Parenthood in Des Moines, Dr. Louviere notified the clinical trial’s director and sent the patient’s medical records to be included in the study.

Yet the trial’s report claimed no complications [were] reported among the 238 women who would end unwanted pregnancies without surgery.

“If near death due to loss of half one’s blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication, I don’t know what does.”

Wendy Wright “The Deceit behind RU-486: Who’s Really in Control?” Family Voice, November/December 2000

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A Woman Tells Her Story Of an RU-486 Abortion

An article in The Family Voice recounts the story of one woman, a 30-year-old divorced mother of two, who had an RU-486 abortion. She says:

“I took the first three tablets. The process had started and it was inevitable. But you have so long to reflect on it, and I became quite upset.

The second stage was pretty awful. After taking [the drug to induce contractions], the pain became very strong. It was just like early labor. I remember finally dispelling the fetus. The nurse told me it was “beautifully formed.”

[This method] may be physically more natural, but psychologically it hits you much harder. You preside over the killing of a baby, completely unblinkingly.”

Wendy Wright “The Deceit behind RU-486: Who’s Really in Control?” Family Voice, November/December 2000

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French Ministry of Health Guidelines on RU-486 Include Crash Cart

RU-486 has been used for a long time in France. However, the French Ministry of Health requires that abortion facilities be equipped with an EKG, IV equipment and a “crash cart” with a defibrillator in the event of a heart attack resulting from RU-486 pills and prostaglandin.

JC Willke “Why Can’t We Love Them Both: Questions and Answers about Abortion” (Cincinnati Ohio: Hayes Publishing Company, 1997) p 131

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Woman Who Received an RU-486 abortion: “I Passed out from the Pain”

Pro-choice author Jennifer Baumgardner, who started the “I Had an Abortion” T-shirt campaign, let a woman who had had a medical abortion (by pill) tell her story in her book Abortion & Life:

“As for the actual abortion, I was just lying on my bed, trying to read, when the cramping came on. It was one of the most painful experiences I’ve ever been through. I just felt like my insides were tearing themselves apart. I felt so alone and I didn’t know what to do. At a certain point, I passed out from the pain.”

Jennifer Baumgardner “Abortion & Life” (New York, NY: Akashic Books, 2008) p 117

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RU-486 Abortion: “I Saw My Baby”

“I got a non-surgical abortion. Nothing prepared me for what happened. First off it was the worst pain I have EVER felt in my life. And secondly, I SAW my baby. He/she looked so human already. I had no idea that my baby was so big after only 2 months. Just because you can’t see or feel it inside you doesn’t mean it’s not alive.”

Testimony from the pro-life site Stand Up Girl (Accessed May 25, 2006)

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Woman Describes Her RU-486 Abortion in Newsweek

RU486 abortions, done by a combination pill (to kill the baby) and suppository (to induce labor) are often done before features of the baby are discernible.

But not always. One woman discussed seeing her aborted baby. She had had two previous surgical abortions:

“There was a little bit of regret about seeing [the fetus], because it had little hands. I remember little fists. I felt more responsible this time.”

Debra Rosenberg and Michele Ingrassia “Blood and Tears” Newsweek Sept 18, 1995. Vol 126, Issue 12

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RU-486 Abortion As “Penance”

In an article in the Washington Times, author Hanna Rosin discusses quotes abortion provider Kathy Rogers saying:

“[RU-486 is] not just a pill; it’s a process. And it’s not going to be fast or easy or simple.”

Rosin discusses why some women choose to undergo chemical abortions, even though they are so much more painful and drawn out than surgical ones.

“[the woman who was interviewed after her chemical abortion] expresses a feeling the pill’s advocates don’t like to talk about, but which nonetheless seems common to the woman who have chosen this new method.

It served for her a form of penance, a way of grappling with her ambivalence over any kind of abortion.”

The interviewed woman is quoted saying:

“It was like, if I’m going to do this I have to take the responsibility and do it, and I have to put myself through something hard. It would have been cowardly to have someone fix it for me in some easy, safe way. It would not have felt right.

You know, I still think about it almost every day. I will always wonder what this baby would have been like…”

Rosin says that abortionists she has interviewed “often hear some form of Rachel’s personal calculation.”

“Pain, Penance and RU-486” by Hanna Rosin “Washington Post” October 14, 2000 p A04

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