Category: Women’s Health

Danco Laboratories , the manufacturer of the abortion pill RU-486 issued this warning to emergency room doctors. Below are exerpts of the letter:

November 15, 2004

Dear Emergency Room Director:

Danco Laboratories is providing this information to assist you in taking care of patients who may present in an emergency room setting following treatment with Mifeprex ® (mifepristone) and misoprostol. In particular, you should be aware of the rare events – serious infection, prolonged heavy bleeding and ruptured ectopic pregnancy – discussed below.

There may be some women who present to an emergency room with serious and sometimes fatal infections and bleeding that occur rarely following spontaneous (miscarriage), surgical and medical abortions, including following Mifeprex use, and childbirth. A high index of suspicion is needed for timely diagnosis and intervention in these patients.

A summary of  the updated warnings follows:

Infection and Sepsis

In postmarketing experience following the use of Mifeprex and misoprostol, we have received a few reports of cases of serious bacterial infection, including very rare cases of fatal septic shock

Vaginal Bleeding

Vaginal bleeding occurs in almost all patients during the treatment procedure (see WARNINGS). According to data from the U.S. and French trials, women should expect toexperience vaginal bleeding or spotting for an average of nine to 16 days, while up to 8% of all subjects may experience some type of bleeding for 30 days or more. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Patients should be counseled to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion. Excessive vaginal bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions.

Ectopic Pregnancy

Additionally, in postmarketing experience we have received a small number of reports of ruptured ectopic pregnancy. Physicians should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy since some of the expected symptoms of a medical abortion may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifeprex.

We rely on medical feedback from health care professionals and therefore remind you to report serious adverse events and any on-going pregnancies following treatment with the Mifeprex regimen to us.

Please provide a brief clinical synopsis (by postal mail, email or phone):

Medical Director

Danco Laboratories, LLC
P.O. Box 4816
New York, NY 10185

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An anonymous woman describes an abortion by RU-486 at six weeks.

“Back at the dorm, hours later, I know that I writhed in my twin bed, suffering from debilitating, convulsing cramps. My roommates, best friend, and boyfriend hovered around; they brought me pain killers, Tiger Balm, hot-water bottles, and applesauce, and all the while they stroked my head and conferenced in the background about how I was doing. I bled profusely as my body rejected the fetus that had been described to me as “the size of a grain of rice.” I threw up. And finally, I fell asleep.”

Anonymous “I Had an Abortion” The Boston Phoenix Sept 24, 2008

http://thephoenix.com/Boston/News/68790-I-had-an-abortion/?page=1#TOPCONTENT

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FDA report “Mifepristone US Postmarking Adverse Affects Summary through April 30, 2011”

“At least 2,207 cases of severe adverse reactions, including hemorrhaging, blood loss requiring transfusions, serious infections and death.”

Cited in “Chemical Abortion: What We Don’t Know Is As Scary Is What We Do”

http://www.aul.org/chemical-abortion-what-we-don%E2%80%99t-know-is-as-scary-as-what-we-do/#_ftn3

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“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, 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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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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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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