The Planned Parenthood abortion corporation has long ignored FDA rules and subjected women to dangerous abortions by giving them the abortion drug outside the guidelines the FDA had put in place.
The abortion drug is responsible for the deaths of dozens of women worldwide, including several in the United States alone, and it has injured at least 1,100 women in the United States alone as of 2006 figures from the Food and Drug Administration. But that hasn’t stopped the agency from deciding today to change the rules and guidelines the abortion industry once had to follow to protect women’s health.
The dangerous RU 486 abortion drug has nearly claimed the lives of two million unborn children in the United States since its approval at the end of the Clinton administration. In addition to the number of unborn children whose lives have been lost to the abortion drug, women have suffered as well, as a Planned Parenthood study admits at least one woman is seriously injured from the abortion pill daily.
Because of the high failure rate and the risks involved with RU-486 in later pregnancies, the FDA limited approval for use only in the first 49 days from the start of a woman’s last menstrual period. Planned Parenthood, by its own admission, ignores this limitation.
Now, the Food and Drug Administration announced on Wednesday, that it had given into to Planned Parenthood’s demands and altered the approved use of Mifeprex, (also known as Mifepristone or RU486), to come in line with off-label protocols used by Planned Parenthood and other abortion businesses. The FDA has announced that it is extending the allowed time period for use of the abortion drug to 70 days.
But, according to the clinical trial submitted to the FDA for approval, the RU-486 regimen fails in 1 out of 12 women with pregnancies less than or equal to 49 days. Those failures, however, increase to 1 out of every 6 women with pregnancies just one week advanced (50-56 days), and further still to nearly 1 out of every 4 pregnancies at 57-63 days gestational age. When using RU-486, 1 out of 100 women with pregnancies less than or equal to 49 days will require emergency surgery; however, this number increases dramatically to 1 out of every 11 women with pregnancies of 57-63 days gestational age.
A spokesman for a leading pro-life group says this FDA change will cause more abortions with the abortion drugs and more failures that kill or injure women.
“The abortion pill is a huge cash cow for the Abortion Cartel, but the process of abortion using the abortion pill cocktail of two drugs, Mifeprex and Cytotec, is long, painful, bloody, and unpredictable for women and deadly for pre-born children,” Troy Newman of Operation Rescue told LifeNews.com.
“Extending the upper recommended gestational limit from 49 to 70 days only ensures that the risk of incomplete abortion will be multiplied, as will the number of women visiting emergency rooms around the country suffering from partial or failed abortions,” he said. “Relaxing the usage protocols allows abortion businesses to step up their aggressive marketing of the drug to vulnerable pregnant women and plays into Planned Parenthood’s goal of selling the abortion drug at every one of their outlets, whether their facilities are equipped to cope with known abortion pill complications or not. This creates additional risks to women for the sake of Planned Parenthood’s increased profits.”
“Planned Parenthood of Kansas and Mid-Missouri expanded sales of the abortion pill regimen to their Wichita office earlier this month, which is ill-equipped to treat incomplete abortions or other complications. Licensed physicians who will dispense the abortion drugs hold no local hospital privileges, leaving women to fend for themselves when expected complications arise,’ Newman continued.
“The FDA should be more about protecting the public from exploitative and predatory uses of drugs rather than pandering to Planned Parenthood and the rest of the Abortion Cartel,” he concluded.
The FDA, with no fanfare, released its April 2011 report showing 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 stated.
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 at that time.
An FDA panel eventually investigated the deaths and found that the vaginal, rather than oral, use of the abortion drug was likely contributing to the deaths. Planned Parenthood had been going against the FDA guidelines on using the abortion drug and changed its protocols to allow for oral use after women died at their facilities.
In 2012, Chris Gacek, who received a Bachelors of Science in economics from the Wharton School, University of Pennsylvania, a Masters and Ph.D. in political science from Stanford University, and a J.D. from the University of Virginia School of Law, authored a comprehensive report on mifepristone.
On the unsafe effects of RU 486 for women:
Dr. Ralph Miech, emeritus professor at Brown University’s medical school, has published two peer-reviewed articles describing potentially undesirable effects related to RU-486 and its anti-glucocorticoid properties. First, he believes that RU-486′s blockade of cortisol receptors on bacteria-destroying white blood cells may impede the antibacterial defense mechanism of the innate immune system. Such interference, he hypothesizes, played a significant role in the deaths of at least five North Americans in which there was a post abortion, bacterial invasion of the uterus and subsequent septic shock. Second, prompted by an article describing mifepristone-related adverse events with significant and unexpected levels of hemorrhage, Miech’s second article argues that RU-486 appears to interfere with the body’s ability to control uterine hemorrhage. Such interference, if true, would be a dangerous feature of an abortion procedure that is designed to produce a simulated miscarriage. As will be noted below, the number of hemorrhage/transfusion and serious infection cases revealed by FDA support Miech’s concern about RU-486 and hemorrhage.
Looking at specific cases of the abortion drug hurting women:
FDA’s April 2011 RU-486 Adverse Events Summary states that “[t]he estimated number of women who have used mifepristone in the US through the end of April 2011 is approximately 1.52 million women.” As noted above, FDA calculated that by that date there had been 2,207 adverse event reports submitted to FDA. Prior to a 2006 oversight hearing on RU-486 safety, FDA told Rep. Mark Souder (R-Ind.) that it had received 1,070 AERs. Thus, in the second five years of mifepristone marketing in the United States, the FDA received an additional 1,137 AERs-a total which seems consistent with the first five years.
The April 2011 RU-486 Adverse Events Summary states that there were 612 reports of hospitalization received as of April 30, 2011.
FDA’s April 2011 RU-486 Adverse Events Summary indicates that 339 women “experienced blood loss requiring a transfusion” after taking the RU-486 abortion regimen.
By April 2011 FDA had fifty-eight reports of ectopic pregnancy cases – with two resulting in death – in conjunction with mifepristone-misoprostol use.
In the April 2011 RU-486 Adverse Events Summary FDA associated fourteen American deaths to the use of the mifepristone-misoprostol abortion regimen.
And, according to a study on medical abortion’s safety and effectiveness published in Obstetrics & Gynecology and that Gacek noted, the abortion drug is more dangerous for women than surgical abortions:
“Overall, medical abortion had roughly four times the rate of adverse events than surgical abortion did: 20.0% of women in the medical-abortion group and 5.6% of women in the surgical-abortion group had at least one type of adverse event. Hemorrhage, as an adverse event, was experienced by 15.6% of medical abortion patients compared with 2.1% for surgical patients. Incomplete abortions were experienced by 6.7% of medical abortion patients while only 1.6% of surgical patients had incomplete abortions. The rate for surgical (re)evacuation of the uterus was 5.9% (medical) versus 1.8% (surgical) for all causes (hemorrhage, infection, incomplete abortion).
A 2006 review of Adverse Event Reports (AERs) related to the use of the RU-486 drug regimen, conducted by Dr. Margaret M. Gary, M.D. and Dr. Donna J. Harrison, M.D. found, “AERs relied upon by the FDA to monitor mifepristone’s postmarketing safety are grossly deficient due to extremely poor quality.”[iv] Drs. Gary and Harrison noted that the deficiency in the AER reports was widespread and consequential,
[A] majority of the AERs 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.[v]
What is perhaps even more disturbing than the lack of essential facts in what is reported to the FDA about chemical abortions—precluding accurate, or even any, analysis—is what is not being reported to the FDA about the dangerous drug regimen.
The limitation of the AER system was detailed by Michael F. Mangano, Principal Deputy Inspector General of the Department of Health and Human Services, in his testimony before the U.S. Senate committee,
Adverse Event Reporting systems typically detect only a small proportion of events that actually occur. They are passive systems that depend on someone linking an adverse event with the use of a product, then reporting the event … Adverse Event Reports in and of themselves typically cannot generate conclusive evidence about the safety of a product or ingredient. Rather the system generates signals that FDA must assess to confirm if, in fact, a public health problem exists… With limited information to draw upon to generate signals, it is not surprising that FDA rarely reaches the point of knowing whether a safety action is warranted to protect consumers.[vi]
Adding to the uncomfortable fact that the FDA reports capture “only a small proportion of events that actually occur,” is that abortion providers are openly flouting the FDA protocol and state laws designed to protect women against these dangers.
Planned Parenthood violates the FDA protocol in multiple ways, while Planned Parenthood’s own studies acknowledge that its off-label use of chemical abortions has come at the cost of women’s lives and “higher-than-expected” consequences to their health.
According to a 2009 Planned Parenthood study, only after women suffered serious infections and died did Planned Parenthood stop the vaginal use of misoprostol, an off-label practice never approved by the FDA.
Prompted by the deaths that occurred after medical abortion and internal data that show a higher-than-expected rate of serious infection, [Planned Parenthood Federation of America] changed its medical abortion protocol at the end of March 2006.[vii]
Jeanne Monahan, formerly of the Family Research Council and now with March for Life, previously said the danger associated with the RU 486 abortion drug are 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.”
“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.