General Information / History / Stats / Types

RU 486 / Mifepristone / Mifeprex & Adverse Health Reports (2011)

RU-486 / Mifepristone / Mifeprex Can Result in Serious Health Issues — Even Death — For Users

New FDA Report: Abortion Drug Kills 14 Women, Injures 2,200

FDA Report on Mifepristone — http://downloads.frc.org/EF/EF11G29.pdf

Current Report on Mifeprex

FDA Confirms RU-486 Abortion Drug Kills: More Than 2,200 'Adverse Event' Results Documented

 

 

RU-486 / Mifepristone / Mifeprex Can Result in Serious Health Issues — Even Death — For Users

Related: National Right to Life article, "FDA Report Reveals More RU 486 Deaths & Complications — http://www.nationalrighttolifenews.org/news/2011/07/fda-report-reveals-more-ru486-deaths-complications/

 As you are aware, Mifeprex, the abortion pill, is lethal to 95% or more of the unborn that are its target. Lesser known is the fact that it also poses serious risks for the pregnant woman.

The FDA safety trials a decade ago found that at 7 wks gestational age, 8% of women required a D&C to complete their abortion (because of heavy bleeding or incomplete abortion). At 8 wks, 16% required a D&C, and at 9 wks (63 days), 23% required D&C.

The FDA protocol recommends Mifeprex be used within the 7 week limit.

However, by common off label usage, the drug is used up to 9 wks—and even that is a guess, since ultrasound is not required prior to Mifeprex usage, and "LMP" is a notoriously inadequate way to judge gestational age, often being 1-2 wks off.

So, many women taking the drug will be in the 23% category for an urgent D&C.

The FDA does collect voluntary Adverse Event Reports (AER) on drugs. Here is a summary of the current Mifeprex AER, courtesy of Liberty Counsel:

Abortion Drug RU-486 is Quietly Killing Women Across America

The Food and Drug Administration (FDA) quietly released a report dated in April 2011 that details the dangers for women who are considering using Mifepristone, also known as the abortion drug "RU-486."

The report states that 14 women have died and more than 2,200 women have experienced serious medical problems from the drug in the United States alone. In addition, the complications of this abortion-inducing drug have led 612 women to be hospitalized, of which 339 were required to undergo a major blood transfusion and 256 suffered from a variety of infections.

This study also reveals that abortion businesses are misdiagnosing or misusing this drug. In the face of the FDA's warning against prescribing it to "patients with confirmed or suspected ectopic pregnancy," there were 58 cases where it was given to women who had an ectopic pregnancy.

In spite of serious complications, this drug is continuing to be marketed as "safe" and, according to the Abortion Care Network website, "Many women feel that Mifepristone is private and more natural."

These results reinforce other findings by the FDA, which reported adverse effects associated with RU-486 in 2006. That earlier study showed 1,100 women having experienced serious medical repercussions as a result of taking this abortion drug.

We warned that the RU-486 abortion drug would kill and injure women. But the Obama administration and its abortion allies have lost common sense, because they are blinded to reality by their radical commitment to the holocaust. Obama and the FDA must halt this destructive abortion chemical.
[14 July 2011, J DeCook MD, AAPLOG, e-letter]

New FDA Report: Abortion Drug Kills 14 Women, Injures 2,200

Related: National Right to Life article, "FDA Report Reveals More RU 486 Deaths & Complications — http://www.nationalrighttolifenews.org/news/2011/07/fda-report-reveals-more-ru486-deaths-complications/

 The Food and Drug Administration has quietly released a new report about the deaths of and injuries to women from the dangerous RU 486 abortion drug and the Obama administration has done nothing to make the information available to women.

Following its approval during the Clinton administration, the FDA released a report in 2006 that received widespread attention for showing more than 1,100 women had been subjected to “adverse effects” resulting from their taking the abortion drug mifepristone, commonly known a RU 486.

Pro-life advocates have waited five years for the FDA to come out with a new report of problems associated with the drug — despite mounting evidence that the abortion drug continues to kill and injure women across the globe.

The FDA, with no fanfare, has released a new report, dated April 30, 2011 — [FDA Report on Mifepristone — http://downloads.frc.org/EF/EF11G29.pdf ].

The report indicates 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.”

Given that the RU 486 abortion drug caused sepsis, a potentially lethal infection that resulted in the deaths of women from around the world, the “serious infections” were very likely life-threatening situations.

“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.

Jeanne Monahan of the Family Research Council commented on the new report.

“The dangerous complications associated with this drug continue include hemorrhaging and infection. In the U.S., at least 612 women have been hospitalized after taking RU-486; and at least 339 women required blood transfusions as a result of serious blood loss after taking the abortion drug,” she said.

“Marketing the abortion drug as simple and painless, such as taking an aspirin, is dangerously misleading to women. RU-486 is in a class of drugs categorized as selective progesterone receptor modulators, which, in addition to blocking progesterone necessary for the developing baby, also suppresses a woman’s immune system. Additional

ly, it is sometimes the case that the remains of the pregnancy are not entirely expelled from a woman’s uterus, causing infection and other problems,” she said.

Monahan also complained about the usage of the mifepristone abortion drug in cases where an ectopic pregnancy was present.

“Clearly highlighting the need for more stringent medical oversight, the report also indicates that 58 women were prescribed RU-486 despite having ectopic pregnancies,” she said. “To state it more clearly, a woman who has an ectopic pregnancy and takes the RU 486 regimen places her life in danger.”

Monahan says the dangerous status of the abortion drug is not limited to the United States.

“It is not only women in the U.S. who are suffering as a result of chemical abortion, it is a worldwide trend. A recent Australian health department audit of nearly 10,000 abortions performed in 2009 and 2010 compared the safety of RU-486 with surgical abortion, with the outcome being in the words of one major media outlet “The Abortion Pill ‘Less Safe than Surgery,’” Monahan explained. “The Australian report showed that 1 in 18 patients who used RU-486 had to be re-admitted to hospitals (a total of 5.7% of women vs. only .4% of surgical abortions.) The same study revealed that as many as 33% of women who had second trimester RU-486 abortions required some form of surgical intervention.”

The report also indicated approximately 1.52 million women have used the dangerous abortion drug through the end of April 2001.

“Despite the seriousness and intensity of adverse effects related to RU-486, use of this form of abortion is on the rise, and frequently the regimen is dispensed with less medical oversight than surgical abortion,” Monahan said. “Even more troubling, nationally and internationally, “telemed” dissemination of RU-486 is increasing. Telemed abortions involved doctors proscribing RU-486 through Skype or over the Internet rather than during a patient visit.”

“The bottom line is that abortion drugs are not about improving women’s health but are more accurately about advancing a radical pro-abortion agenda regardless of the impact on women’s health, even when it proves deadly,” she concluded.
[Ertelt | Washington, DC | LifeNews.com | 7/12/11, http://www.lifenews.com/2011/07/12/new-fda-report-abortion-drug-kills-14-women-injures-2200/]

FDA Report on Mifepristone
http://downloads.frc.org/EF/EF11G29.pdf

Current Report on Mifeprex

As you are aware, Mifeprex, the abortion pill, is lethal to 95% or more of the unborn that are its target.  Lesser known is the fact that it also poses serious risks for the pregnant woman.

The FDA safety trials a decade ago found that at  7 wks gestational age, 8% of women required a D&C to complete their abortion (because of heavy bleeding or incomplete AB).  At 8 wks, 16% required a D&C, and at 9 wks (63 days), 23% required D&C. 

The FDA protocol recommends Mifeprex be used within the 7 week limit.

However, by common off label usage, the drug is used up to 9 wks—and even that is a guess, since ultrasound is not required prior to Mifeprex usage, and "LMP" is a notoriously inadequate way to judge gestational age, often being 1-2 wks off.

So many women taking the drug will be in the 23% category for an urgent D&C.

The FDA does collect voluntary Adverse Event Reports on drugs.

Here is a summary of the current Mifeprex AER, courtesy of  Liberty Counsel:

Abortion Drug RU-486 is Quietly Killing Women Across America

The Food and Drug Administration (FDA) quietly released a report that details the dangers for women who are considering using Mifepristone, also known as the abortion drug "RU-486." The report states that 14 women have died and more than 2,200 women have experienced serious medical problems from the drug in the United States alone. In addition, the complications of this abortion-inducing drug have led 612 women to be hospitalized, of which 339 were required to undergo a major blood transfusion and 256 suffered from a variety of infections.

This study also reveals that abortion businesses are misdiagnosing or misusing this drug. In the face of the FDA's warning against prescribing it to "patients with confirmed or suspected ectopic pregnancy," there were 58 cases where it was given to women who had an ectopic pregnancy.

In spite of serious complications, this drug is continuing to be marketed as "safe" and, according to the Abortion Care Network website, "Many women feel that Mifepristone is private and more natural."

These results reinforce other findings by the FDA, which reported adverse effects associated with RU-486 in 2006. That earlier study showed 1,100 women having experienced serious medical repercussions as a result of taking this abortion drug.

We warned that the RU-486 abortion drug would kill and injure women. But the Obama administration and its abortion allies have lost common sense, because they are blinded to reality by their radical commitment to the holocaust. President Obama and the FDA must halt this destructive abortion chemical.

AAPLOG recommends you read the FRC article found at    http://www.aaplog.org/position-and-papers/mifeprex/politicized-science-the-manipulated-approval-of-ru-486-and-its-dangers-to-womens-health/          This will give you excellent background information on how Mifeprex got where it is in the USA today.

In addition, you will find a number of other helpful articles about Mifeprex at   http://www.aaplog.org/position-and-papers/mifeprex/
[APPLOG, 14 July 2011, J DeCook MD, e-letter]

FDA Confirms RU-486 Abortion Drug Kills: More Than 2,200 'Adverse Event' Results Documented

Fourteen women have died in the United States alone and several thousand have experienced an "adverse event" after taking the abortion drug RU-486, according to a "quietly released" government report.

A Food and Drug Administration document, called the "Mifepristone U.S. Postmarketing Adverse Events Summary," is being highlighted by Liberty Counsel, a public interest legal organization that fights on behalf of the right to life, among other issues.

"I hate to say this, but we told you so," said Mathew D. Staver, founder of Liberty Counsel and dean of Liberty University School of Law. "We warned that the RU-486 abortion drug would kill and injure women. But the Obama administration and its abortion allies have lost common sense, because they are blinded to reality by their radical commitment to the holocaust. President Obama and the FDA must halt this destructive abortion chemical."

The report reveals the dangers of taking the drug, even though the Abortion Care Network reports on its website that many women "feel that Mifepristone is private and more natural."

Among the details revealed:

There were 2,207 cases of any adverse event by the cutoff date of April 2011:
— 14 women died.
— 612 were hospitalized, but did not die.
— 339 experienced a blood loss that required a transfusion.
— 256 suffered infections, and 48 had severe infections.

The report said the deaths were blamed on sepsis, the use of drugs, methadone overdose, delayed onset of toxic shock-like syndrome, suspected homicide and ruptured ectopic pregnancies.

&

quot;There were five additional deaths in women from foreign countries … who used mifepristone for termination of pregnancy," the report said.

"Severe infections generally involved 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 report said.

According to Liberty Counsel, the study "also reveals that abortion businesses are misdiagnosing or misusing this drug. In the face of the FDA's warning against prescribing it to 'patients with confirmed or suspected ectopic pregnancy,' there were 58 cases where it was given to women who had an extopic pregnancy."

The organization reported: "Mifepristone suppresses a woman's immune system. In some cases, fragments of the unborn child or other cells are not entirely expelled from the uterus, causing infection and complications. RU-486 can result in endometritis (an irritation of the lining of the uterus), pelvic inflammatory disease (involving the nearby reproductive organs), and pelvic infections with sepsis (a systemic infection spreading beyond the reproductive organs)."

Liberty Counsel noted that the results reinforce other findings by the FDA from 2006, which revealed 1,100 women had experienced serious medical repercussions from taking the drug.

Columnist Jill Stanek wrote just a few months ago on two of the cases, identified in the reporting of Lifenews.com.

Those cases involved a 29-year-old Hispanic woman who died in 2008, just six days after taking oral mifepristone.

The report said her symptoms were "severe abdominal cramping, vomiting, and diarrhea on day 4. She was hospitalized on day 5. … She died of sepsis with acute respiratory distress syndrome."

Another was a 21-year-old white woman who died 12 days after taking mifepristone.

"She died of sepsis with acute renal failure and disseminated intravascular coagulation."

"Many questions," wrote Stanek, "Where did these deaths occur? Why did the CDC wait so long to alert the public, and why in such a nonpublic way."

According to the Family Research Council, the drug appeared to be a problem from the beginning. In an online statement, the organization said, "Ten years ago, the FDA's approval process for RU-486 was flawed, relying primarily on French data that the FDA admitted was marked by 'carelessness,' 'fraud,' and 'evidence tampering.' And while the abortion industry achieved a major victory with the approval of RU-486, women have been the victims of the abortion agenda.

"Other drugs with less extreme adverse affects have been pulled from the market quickly, but not RU-486."

Mifepristone is the drug that abortion industry leader Planned Parenthood wanted to use in the now-challenged "telemedicine abortions" in which the pregnant woman never meets the abortionist.

The procedure was being implemented in Iowa, with plans to expand, but also is being challenged with demands for official investigations.

The issue is that under the procedure set up in Iowa, the patient never saw the doctor dispensing the drugs.

A pro-life organization in mid-America, Operation Rescue earlier obtained confirmation of the process.

The organization documented in a recording Planned Parenthood's explanation of its setup.

"The physician doesn't actually come," the abortion company worker explains. "The physician who prescribes you the medication would be on a computer screen. You'll be on a computer screen. You can see each other and communicate. They're just not physically there.

"You would press a button that's on the screen, and a little box would open up with the medication in it."
[13 July 2011, Bob Unruh, WND, http://www.worldnetdaily.com/index.php?pageId=321929 ]