A new report by a Right-leaning research group challenging the safety record for mifepristone, the FDA-approved abortion pill, is being used to demand retrospective clinical data about its safety.
Despite approvals in more than 100 countries since 1988, the group has concluded — based on examination of insurance records — that 11 percent of 865,000 prescribed mifepristone between 2017 and 2023 experienced some form of Serious Adverse Events (SAE), a Federal Drug Administration measure of bad side effects that is far more than what has been reported over the years in clinical trials or predicted by warnings on manufacturer labels.
Based on the report, entitled “The Abortion Pill Harms Women,” Sen. Josh H. Hawley, R-Mo., last week got the Trump administration to commit to a new safety review.
In fact, since 2014, the use of mifepristone has doubled, and with anti-abortion laws halting clinical abortions across the country, abortion drugs — believed to be “safe” — account for more than 63 percent of all abortions.
So The Washington Post decided to look at the data from the Ethics and Public Policy Center, asking questions to understand it. Glenn Kesler’s analysis shows that unlike clinical data, these insurance claims were not peer reviewed, reflect some claims open to interpretation, raised questions about data sources, and included some numbers within current label warnings. While the overall math holds, the deeper look makes the inclusion of various components less than solid.
The journalistic effort stands out for its rigor in asking follow-up questions about what the top-line assertions suggest, especially since this report is being used to create policy that will affect health services in an era of contentiousness about abortion. We are being asked to swallow whole all kinds of government assertions that do not get questioned at this level about trade and economics, immigration, budget cuts, and especially health.
Analyzing the Report
The report says there were 94,605 adverse events for mifepristone patients in those years, and that because one patient could have more than one event, the researchers took care not to double-count. All adverse events were limited to 45 days after ingesting the drug to avoid any confusion about non-abortion medical issues, according to the center spokesman.
The most serious problems associated with abortion, such as sepsis and infection, rank rather low, indeed within the limits on labels. The Post report breaks down the rest by category.
The largest category is for “Other abortion-specific complications’ (5.68 percent),” or half of the incidents, including insurance claims for mental health diagnoses as well as reported damage to internal organs, remaining fetal tissue, or kidney issues. There were zero mental health diagnoses, but the category was included. What physical problems required treatment were unclear, but they represented follow-up doctor visits requiring an insurance claim.
The other large category was “emergency room visit, (4.73 percent), which by itself does not count as a severe adverse event under FDA definition. Patients on Medicaid or without a primary care doctor often go to emergency rooms. So the report 72 percent of emergency room visits that took place within 45 days of abortion because they could have been for any reason. As Kessler noted, the FDA-approved label of Mifeprex, brand name for the abortion pill, says that clinical studies in the United States found that as many as 4.6 percent of patients had an emergency room visit. Estes said that the nearly identical rate of 4.7 percent in the study further supported “the validity of the data.” In other words, about half the incidents leading to the center’s overall statistics are already on the abortion-pill label.
Another 3.3 percent of incidents involved reports of hemorrhaging or bleeding, a disparity with the drug label rate of 0.1 percent. The study spokesman explained that real-world experience necessarily differs from clinical trial settings. Still, normal bleeding does occur after a medication abortion, and it is unclear whether the study was recording excessive bleeding or use of an insurance code for follow-up treatment. The spokesman responded that incomplete abortions were categorized separately.
Other categories matched well with the predictions since the FDA clinical trials 40 years ago. These included incomplete abortion, requiring surgical abortion if the medication pill combination did not work (it works about 87 to 98 percent of the time); infections, about 1.3 percent of cases, in line with predictions; a need for hospitalization, less than 1 percent; and discovery of ectopic pregnancy, less than 1 percent, which is non-addressable by the medication abortion pills and is supposed to be ruled out as a reason for prescribing the drug. Also under 0.2 percent of cases involved transfusion or sepsis, again in line with label warnings.
Politics and Facts
What we hope is that government agencies, particularly the health agencies, are looking for and analyzing good fact patterns to create policy. The study by the Ethics and Public Policy group seems alarmingly at odds with what the government has been saying, but before throwing policy out the window, perhaps we should be looking at little harder at what such a study says — as the Post has done.
It’s not news that anti-abortion efforts remain in high gear with this administration despite any number of state elections in which abortion rights remain popular by big proportion. The claims to moral authority and “mandates” about abortion policy are troubling, and we constantly feel as if the country is one court decision away from changing its laws to bar even medical abortion. It was surprising that the Trump Justice Department decided this month to oppose continuation of a court case challenging the use of mifepristone on technical grounds, aligning itself with the Biden Justice Department attitudes.
State legislatures in red states continue to pass bills that make it more and more difficult for abortions to occur. Yet there were no questions asked in this study about the tangible harms occurring from abortion restrictions or about the appalling statistics showing the continuing rise of maternal mortality only being worsened under abortion limits.
If anything we’re seeing more attention from Republican leadership on policies to increase the number of births — even as the very same government is moving to strike childcare services, education, childhood vaccination programs and all that is associated with the cost of bringing up infants.
We need to check these things.
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