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Regulations needed to stop dangerous telemedical “medication” abortions — Part II

by | Nov 10, 2021

Chemical abortions are difficult and dangerous

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

Editor’s note. The issues raised here in this series are part of a larger more detailed defense and analysis of the FDA’s regulations on mifepristone offered in National Right to Life’s “Special Report” found at nrlc.org/uploads/reports/RUREMSDefenseReport.pdf.

Yesterday we looked at some of the deaths and injuries associated with use of mifepristone, the abortion pill, and its accompanying prostaglandin, misoprostol. We also saw how these abortions are difficult and complex; that they fail a significant percentage or the time; and that they are challenging and arduous even when they are “successful” and the woman appears to suffer no immediate physical damage.

The U.S. Food and Drug Administration (FDA) knew of some of these problems before it approved the drug and has monitored outcomes with the drug once it hit the market. In light of those observations, it approved the drug only with certain limitations on distribution. It has regularly issued and updated warnings and regulations on its use as data on deaths and other “adverse events” have been uncovered.

These women-protecting limitations and regulations are now under unrelenting attack by the abortion industry, anxious to expand abortion “access” by telemedical and mail-order abortion. It now has a sympathetic supporter in the White House.

There are several serious medical conditions for which health care professionals must screen potential chemical abortion patients.

Early on, the FDA identified several conditions (or contraindications) which might render the use of mifepristone and misoprostol ineffective or dangerous. The label lists:

  • Confirmed or suspected ectopic pregnancy or undiagnosed anneal mass.
  • Chronic adrenal failure
  • Concurrent long-term corticosteroid therapy
  • History of allergy to mifepristone, misoprostol, or other prostaglandins
  • Hemorrhagic disorders or concurrent anticoagulant therapy
  • Inherited porphyries [disorders that result from a buildup of natural chemicals that produce porphyria in your body].
  • Use in patients with an intrauterine device (“IUD”) in place.

Some of these conditions are more common than others and easily remedied (e.g., a woman can use mifepristone once her IUD is removed). But others carry potential for great harm if ignored.

Ectopic Pregnancy

Mifepristone and misoprostol do not work in circumstances of ectopic pregnancy, where the embryo attaches outside of the uterus. Ectopic pregnancy occurs in 1-2% of all pregnancies, so this is no small matter. It is estimated that ectopic pregnancy complications account for up to 9% of all maternal deaths in the United States.

Compounding the problem for those considering use of mifepristone, the common warning signs of ruptured ectopic pregnancy – abdominal pain, uterine bleeding – are expected parts of a standard chemical abortion. This can cause both patients and healthcare professionals to fail to recognize a rupturing ectopic pregnancy until it is too late, even if there has been an ultrasound.

Bleeding Disorders

The potential for hemorrhage is already significant with a method that considers extended and sometimes heavy bleeding a standard part of the process. Women taking mifepristone and misoprostol bleed heavily, sometimes passing large clots, and continue to bleed for days or even weeks.

The possibility that the bleeding will get out of hand is something prescribers warn women to watch for and seek immediate help. It is a reason why it is critical that women with bleeding disorders be screened before pills are prescribed.

Rh Screening

The FDA’s “Warnings and Precautions” section of the Mifeprex (mifepristone) label also includes this caution:

The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

It will not affect the current pregnancy, but a failure to identify and treat a woman with an Rh-negative blood type at this time can mean the death of children in subsequent pregnancies even if that child is “wanted.”

Other Conditions

Health care professionals prescribing mifepristone and misoprostol also need to screen potential patients for other conditions known to pose hazards. These include chronic adrenal failure, corticosteroid therapy, porphyries, or allergies to any of the drugs.

FDA warnings are based on real deaths and injuries associated with use of mifepristone.

Once multiple reports of patient deaths began to surface, the FDA issued special warnings on mifepristone on bleeding, infection, and the risks associated with undetected ectopic pregnancy.

The FDA’s label for mifepristone includes a “Black Box Warning” which warns of “SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING associated with use of the drug”(capitalization, bold type in original). It specifies risks of:

• Atypical Presentation of Infection. Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination. A high index of suspicion is needed to rule out serious infection and sepsis.

• Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed.

This is no mere “scare tactic.” Since its approval, the FDA has recorded two dozen deaths and thousands of adverse events in the United States associated with the use of these drugs.

Infection

A third of those deaths involved rare clostridial infections, seven with Clostridium sordellii, a bacteria commonly found in soil, dust, and even the human gastro-intestinal tract. An anaerobic bacteria, certain strains of C sordellii have the capacity to turn deadly when in an oxygen-poor environment where there may be dead or dying tissue and access to the bloodstream

The medical literature has suggested that the vaginal self-administration of misoprostol, recommended by some clinic prescribers, may play a role in introducing the bacteria to the system. Researchers speculate that one or both of the drugs may facilitate infection by suppressing the immune system.

Clostridium sordellii infections are often deadly, difficult to recognize, and thus typically hard to overcome. But critical treatment may be delayed. The similarity of the signs of these infections to the expected side effects of the chemical abortion process – vomiting, diarrhea, abdominal cramping – often occurring without the presence of fever that distinguishes other virulent infections.

Clostridium sordellii is the deadly bacteria which took the life of teen Holly Patterson. It was identified by the FDA to be the same toxin that took the lives of mifepristone patients Vivian Tran, Channelle Bryant, Orianne Shevin, and others (see Part I).

Once these deaths and other injuries began to come to light, the FDA issued a public health advisory, had the distributor send out warnings letters to doctors, and made modifications to the drug’s label adding the warnings.

Those warnings also addressed issues of bleeding and ectopic pregnancy, which had also proven to be issues.

Ectopic Pregnancy

An undetected ectopic pregnancy which ruptured took the life of mifepristone patient Brenda Vise, the Tennessee pharmaceutical representative we discussed in Part 1. Signs of ectopic pregnancy were missed by clinic personnel expecting the pain and bleeding that normally accompany chemical or “medication” abortion.

Vise’s case has not been the only ectopic pregnancy to garner the FDA’s attention. In its 2018 Post-Marketing Adverse Events analysis, the FDA reported 97 known cases of ectopic pregnancy among mifepristone patients, two of which were recorded as fatal.

The FDA warns that “some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.” It reminds prescribers that use of mifepristone and misoprostol are not effective and thus contraindicated in patients with confirmed or suspected ectopic pregnancies.

Hemorrhage

The FDA’s 2018 Post-Marketing Summary for mifepristone listed hundreds of cases in the U.S. of blood loss so severe that transfusions were required. It noted four cases in the U.S. and internationally where hemorrhage was a contributing factor in patient deaths.

Little is known about the hemorrhaging American patients, but cases like that of European teens Rebecca Tell Berg and Manon Jones, mentioned in Part I, illustrate the severity of the problem.

Rebecca Tell Berg didn’t want a chemical abortion but was talked into it by the doctor at the hospital in 2003. Rebecca took the drugs, passed a “big blob” a couple of days later, but continued bleeding. Six days later, still bleeding, tired, when her boyfriend suggested returning to the hospital, Rebecca told him she had been told to expect to bleed for several days. Returning home at the end of the day, he found her lifeless body in the shower, where she had bled to death.

Manon Jones went on vacation after taking mifepristone and believing she had aborted in June of 2005. When the bleeding didn’t stop, she cut short a vacation with friends and returned to the hospital, She died waiting for a blood transfusion that didn’t come until too late.

As FDA records show, hemorrhage can and does occur with chemical abortion, but caught soon enough, it can usually be resolved with drugs or surgery. Failure to quickly recognize and address the problem right away, however, can prove deadly.

FDA cautions and warnings were warranted.

Clearly, there were well justified medical reasons behind the list of contraindications and warning labels that the FDA issued for mifepristone, concerns that have been borne out by years of women’s experience with the drug in the field.

For this reason, special regulations on distribution were part of this drug’s profile from the beginning and have continued in place through several different administrations.

More tomorrow on the FDA regulations that has been such a focus of the abortion industry’s opposition in recent months.

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