Like almost everything to do with the provision of abortion in this country and elsewhere, very little media attention is paid to the potential adverse effects of the abortion pill.
They are safe and a boon to women, we are led to believe, even though Carol Nolan TD discovered that, in fact, the HSE has no national reporting system in place to identify and report when the use of abortion pills goes wrong – meaning that important data on when abortion pills do cause harm to women is not being gathered in the same way as happens with other aspects of services provided by the state.
But facts, as the saying goes, can be stubborn things. Now, research by the Ethics and Public Policy Center, which analysed data from an insurance claims database that includes 865,727 prescribed mifepristone abortions over a seven-year period in the U.S., claims it has found a much higher rate of serious adverse events in relation to the abortion pill than was previously acknowledged.
In fact, the researchers claim that more than 10% of women many be suffering serious after effects from taking the abortion pill – including sepsis and hemorrhaging – and that the real-world rate of serious adverse events was found to be at least 22 times as high as the rate generally associated with its use.
The results of the research – which is not peer reviewed – encapsulated in the summary of the research are quite shocking, and the recommendations based on those findings should also be a wake-up call for policymakers and physicians in this country:
This largest-known study of the abortion pill is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.
The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of “less than 0.5 percent” in clinical trials reported on the drug label.
The FDA should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects.
The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.
The analysis of insurance claims showed that serious adverse events after taking the abortion pill were 22 times higher than what is reported on the drug label. That is simply astonishing. The difference between the real-world experience and what was reported from clinical trials – and therefore passed on as reliable information to women – is staggering.
The serious adverse events include sepsis, infection, or hemorrhaging. As the researchers noted, those events can be life-threatening. That led them to the conclusion that: “simply stated, mifepristone, as used in real-world conditions, is not “safe and effective”.”
“Our real-world post-market observational study of mifepristone is, to our knowledge, the most comprehensive study of chemical abortion safety ever conducted in the U.S.,” they explained.
“We identify and include 865,727 prescribed mifepristone abortions, 28 times as many as were included in all FDA-cited clinical trials combined. Our dataset is more recent, no earlier than 2017, while the FDA approval of mifepristone relies entirely on data from more than a decade ago.”
“The women in our dataset are broadly representative of the women who obtain mifepristone abortions in the U.S.; they are not a prescreened group of generally healthy women recruited into various clinical trials conducted at different times around the world,” they pointed out – adding that “the women in our dataset receive (or fail to receive) pre- and post-abortion healthcare of the real-world quality that prevails in the U.S. today, not the carefully controlled regimen of care that ordinarily prevails in a clinical trial.”
The findings of the research points to more than 3,000 adverse effects in relation to ectopic pregnancy. That brings to mind a recent case study published in the Journal of the Irish Medical Organisation which revealed that a woman who had taken prescribed abortion pills later presented with a life-threatening ruptured ectopic pregnancy in Maternity Hospital Limerick – with experts saying the practice of not providing an ultrasound in medical abortion could lead to death where it was not understood that ectopic pregnancy was involved.
BACKGROUND
On the history of the drug under examination, the EPPC researchers said that Mifepristone was initially developed by the French pharmaceutical company Roussel Uclaf S.A. and brought to the United States at the urging of President Clinton and after Congressional pressure.
It was approved by the FDA “as being safe and effective in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.”
“The original FDA-approved drug label for Mifeprex (the brand name of mifepristone) from September 2000 indicated use of the drug for “the medical termination of intrauterine pregnancy through 49 days’ pregnancy.” It required several modest safeguards for women’s health,” the paper noted:
Treatment with Mifeprex and misoprostol for the termination of pregnancy requires three office visits by the patient. Mifeprex should be prescribed only by physicians who have read and understood the prescribing information. Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
During the Obama and Biden administrations, those initial safeguards were altered in order to increase access to abortion. Under the current Risk Evaluation and Mitigation Strategy (REMS) in effect since 2023:
-a mifepristone abortion now requires as a little as one telehealth visit with any approved healthcare provider (not necessarily a physician),
– a woman may self-administer drugs obtained from a mail-order pharmacy, and
– the prescriber need not report any adverse events unless he or she knows that a patient has died.
“The current FDA-approved drug label refers to the results of 10 clinical trials with a total of 30,966 participants, less than 0.5 percent of whom reportedly experienced serious adverse reactions. But these figures are based entirely on data from trials taking place more than a decade ago”, the EPPC noted.
Chemical abortions—the vast majority of which are performed using a combination of mifepristone and misoprostol—now account for roughly two-thirds of all abortions in the United States. In Ireland and Europe, a similar pattern has emerged: In 2022, 86% of abortions in England and Wales were medically induced.
DEATHS AFTER PILL USE TO BE EXAMINED
Remarkably, the researchers did not include deaths that may have occurred as a adverse event because insurance claims data did not code for that outcome – but the analysts say they hope to show the rate of death in a subsequent report.
We followed the official FDA definition of “serious adverse event.” To do so, we identified relevant ICD-10 diagnosis codes and CPT/HCPCS procedure codes for adverse events from multiple sources:
- CDC Severe Maternal Morbidity (SMM) indicators,
- CMS Diagnosis-Related Group (DRG) 770 and 769 codes,
- FDA Adverse Events Reporting System (FAERS) reports (interpreted and translated into diagnosis and procedure codes by the doctors on our team), and
- a small number of (mostly gynecological) codes suggested by our doctors.
These codes were then graded by a team of physicians using the the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5), which categorizes adverse events by severity on a 5-point scale. We included CTCAE Grade 3 (severe) and Grade 4 (life-threatening). We did not include Grade 1 (mild) or Grade 2 (moderate). (Grade 5 is death, which would count as a serious adverse event under the FDA definition but could not necessarily be observed in the insurance claims data. We hope to show the rate of death in a subsequent report.)
In addition, they only included hospitalizations and emergency room visits with abortion-related diagnosis and procedure codes are included in their analysis, and kept to the six categories of serious adverse events identified in the clinical trials for the abortion pill, which were: sepsis, infection, transfusion, hemorrhage, hospitalization, and emergency room visit.
They also considered “FAERS received reports of various events that our doctors judge to be life-threatening and have grouped into broad categories: ectopic pregnancy, surgery, cardiac, pulmonary, thrombosis, and anaphylaxis”; along with repeated (surgical) abortion procedures which are considered serious adverse events; and other abortion complications include codes specifically related to an abortion or miscarriage, as well as life-threatening mental health diagnoses, etc.
Only serious adverse events that occurred within 45 days following the abortion, were considered in the analysis. “This is conservative, as some adverse events may present later (and studies relied on by the FDA used a timeframe as long as 72 days),” the report said.
The study authors – Jamie Bryan Hall, EPPC’s director of data analysis, and Ryan T. Anderson, EPPC’s president – called the results a “truly shocking and sad reality.”
“We weren’t exactly surprised by these findings, as other studies of smaller datasets have found significant safety problems with chemical abortion drugs — particularly after the Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved,” the authors said in a statement.
“The largest limitation, which we’re working to address, is that there is no insurance code for death — and sadly, we know that women die from complications resulting from the abortion pill.”
Their comments are correct: the results should be a wake up call for anyone who cares about women’s safety. Will the Minister for Health, Jennifer Carroll MacNeill, take note of this study and commission something similar seeking to understand the experiences of women in Ireland and potential threats to their safety? Or will this government continue to whitewash the reality of almost every aspect of abortion?
I asked Danco Laboratories for a comment in relation to the findings of the EPPC research but they have not yet responded.