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Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)

by | Apr 12, 2023

Part Three

By Randall K. O’Bannon, Ph.D., National Right to Life Director of Education & Research

Editor’s note. This is the third in a series by Dr. O’Bannon in which he debunks seven of the many, many myths about how and why the FDA approved and managed Mifepristone. On Monday he addressed Myths 1 & 2.  On Tuesday he analyzed Myths 3 & 4.

MYTH 5: Mifeprex (mifepristone) has an excellent safety record. 

Reality: Mifepristone has been connected to more than two dozen maternal deaths and thousands of maternal injuries and “adverse events.’

Every “successful” chemical abortion is arduous, painful, bloody, and messy and results in the death of at least one innocent child.Millions of babies have died. Thousands of women have been injured. This is hardly the profile of a “safe” drug.

It must be remembered that this drug works by turning a healthy pregnant woman’s body against its natural course and against the mother’s own child. Mifepristone blocks the signal of the pregnancy hormone progesterone, causing the body to have to suddenly “switch gears” and initiate a menstrual cycle while the young child is settling and beginning his or her growth spurt in the protective, nourishing environment in the womb.

Mifepristone effectively cuts off that supply of nourishment to the womb, essentially starving or suffocating the child to death. 

Misoprostol, the prostaglandin, which is the second drug used in the process, comes along a day or so later to stimulate powerful uterine contractions to dislodge and expel the child.

This triggers a round of painful cramps and bleeding with the mother. Some abortion advocates liken this to a standard heavy period, but women who’ve gone through it say that it is much worse.

Pain can be severe and last for hours. Prescription pain killers may prove inadequate.  Cramps can be almost violent, culminating in episodes of nausea, vomiting, and diarrhea.  Again, these are consequences faced by healthy women taking this “safe” drug.

Women bleed more from chemical abortions than they do from surgical ones. Bleeding can be heavy and may go on for days, even weeks. Women may pass enormous clots. Recall that women are not merely passing what might be thought of as the normal menstrual load of shedding uterus, but the child and all the tissue connected to the pregnancy.

Complications are common

The bleeding normally tapers off, but not always. A certain number of women hemorrhage and require some sort of surgical or medical intervention. Add to that the women who go on to have surgical abortions after their chemical abortions fail.

Extended bleeding in a closed place offers a perfect environment for a deadly anaerobic bacterium like Clostridium sordellii.  The bacterium is common but infections are rare, but there was a sudden surge in cases once abortion with mifepristone began to be done, particularly among those who followed the advice of the sort of abortion “experts” the FDA consults regularly and self-administered the misoprostol vaginally.

About 1-2% of pregnancies are ectopic, that is, they implant somewhere outside the uterus. They can prove fatal to both mother and child if they go undetected and rupture. Mifepristone does not treat these pregnancies. But if a woman with an ectopic pregnancy takes mifepristone and starts to cramp and bleed –normal signs of an ectopic pregnancy and the need for immediate medical intervention – both patients and doctors may not recognize the emergency until too late.

Problems, failures, adverse events tend to increase the farther along the pregnancy, which is why the FDA has always had a cut-off date and tried to ensure that prescribers could accurately determine gestational age and screen for ectopic pregnancies.

Even with those precautions, a number of mifepristone patients died.

The FDA’s most recent post-marketing report says its records show 28 deaths among U.S. mifepristone patients, 97 ectopic pregnancies, and more than two thousand women dealing with “adverse events” including infections, hemorrhage, transfusions, or hospitalizations for some related effects.[1]An additional 13 deaths were reported from other countries (FDA, “Mifepristone U.S. Post-Marketing Adverse Events Summary through 06/30/2022”).

Abortion pill advocates argue that the FDA never claims that mifepristone caused these deaths and says that this report includes deaths from unrelated causes, such as homicide, suicide, or drug overdose, but this ignores the cases where use of abortion pills were clearly connected, such as deaths from hemorrhage, infection, and the rupture of ectopic pregnancies.

Claims that the pills were not directly, causally responsible for the infections, the ectopic pregnancies, or any of the other precipitating events neglects how the chemical abortion process exposed them to such dangers by creating the conditions where the bacteria might be introduced and thrive, or by masking or mimicking the symptoms of an ectopic pregnancy that would have, under normal circumstances, likely been noted and addressed.

Many problems never reported

The truth is that these reports only represent the tip of the iceberg. These are only the cases which have been reported back to the FDA. There is reason to think that there are many, many more which the FDA never hears about.

Early on, when a woman had a problem and contacted the office of the prescriber who gave her the abortion pills, that prescriber was supposed to not only address her problem but record her complication and pass it along on to the sponsor (the distributor) who was to send this information to the FDA. In 2016, though, upon determining that it had a sufficient record to build an adequate “safety profile” of the drug, the FDA decided to drop the requirement that all serious adverse events be reported back to the agency, though it still asked that any patient deaths be reported.

There was record of a substantial number of deaths and injuries at that point, but still reason to  believe that many were being missed.

As we have already pointed out in earlier sections, women experiencing problems with their chemical abortions often go to the emergency room or their own personal doctor rather than returning to the clinic or calling the prescriber who they may have met only once (if at all) and who may have counseled them to go elsewhere in the event of emergency.

If they do not return the clinic’s phone calls or answer the abortion pill provider’s emails, the prescriber will likely have no record of the woman’s crisis.

This is only compounded by the fact that many prescribers have explicitly advised women not to reveal to medical personnel in the emergency room that they have taken the abortion pill, but merely to say that they are suffering from a miscarriage.In these instances, a woman’s case would probably never be connected to the abortion pill, and she would probably end up counted as one more safe use of mifepristone.

The FDA used to direct women to take their medication guides with them to the emergency room and tell medical personnel there that they had taken the abortion pill, but the agency decided in its most recent guidance to drop that instruction from its latest REMS and Patient Guides, allowing more and more of these cases to escape being attributed to the mifepristone/ misoprostol combination.

The record still shows significant risk

Nevertheless, what we do have gives us a clear picture of a drug with numerous serious risks. It is difficult, painful, and bloody for nearly everyone who takes it. When it works, it takes the life of an innocent human being. It has been connected, time and again, to hemorrhages, infections, and ruptured ectopic pregnancies. Healthy women in the prime of their lives have taken this drug and died.

While the FDA appears to have dismissed these reports as significant grounds for withdrawing the agency’s approval of the drug, it has taken them seriously enough to impose and maintain significant limits on this drug’s distribution, such as the required certification of prescribers and pharmacies.

This is why, over objections from the administration and from the abortion industry, they have kept these regulations in force, in some form, even to the present day.

There is no way to look at this drug and its record and call it unqualifiedly “safe.”

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