Chemical Abortion Drugs Aren’t Safe: Here’s Why
After Alliance Defending Freedom announced a first-of-its-kind lawsuit challenging the FDA’s approval of chemical abortion drugs, many in the establishment media panicked.
In the months that have followed, the public has been inundated with claims about how safe these drugs are. We’re routinely told that chemical abortion drugs are safer than Tylenol, that side effects of the drugs are exaggerated, and that serious complications almost never occur.
These claims are categorically false. Chemical abortion drugs are dangerous, and claims to the contrary are not supported by the evidence. (Most of the research presented below comes from the Charlotte Lozier Institute, which filed an amicus brief in ADF’s lawsuit against the FDA.)
Deficient data produces shaky statistics
The claim that chemical abortion drugs are safe relies not just on flawed evidence, but on a severe lack of data.
Total number of abortions
It might seem surprising, but we do not actually know how many abortions take place in America every year. There is no federal database tracking abortions because state reporting is voluntary and many women pay for abortions out of pocket.
To put this in perspective, the two leading sources of abortion statistics reached vastly different numbers in their most recent calculations. In 2020, the Centers for Disease Control and Prevention (CDC) reported 620,327 abortions while the Guttmacher Institute calculated 930,160—50% more. The CDC relied on state health authorities while Guttmacher used data from abortion providers. The disparity between their results highlights the lack of data about abortions in general, let alone other factors related to abortion.
Complications from abortion
Even more worrisome, the number of abortion complications is also unknown. As with abortion numbers in general, data is limited by incomplete reporting. Only 28 states require abortionists to report complications. And only a quarter of states require other health-care providers to do the same. Thus, abortion complications will be vastly underreported.
What data that does exist can vary widely. One frequently cited study conducted by the pro-abortion group Advancing New Standards in Reproductive Health (ANSIRH) claimed that fewer than 1 percent of California women who received an abortion through the state’s Medicaid program visited an emergency room with complications within six weeks of the abortion. But a larger study reported different results: out of 423,000 abortions across 17 states, over 2 percent of women who had a surgical abortion—and over 5 percent of women who had a chemical abortion—presented to an ER with a complication within only 30 days of the abortion.
Why the disparity in the number of complications? The answer lies in medical coding—the standardized documentation for medical procedures and visits with health-care providers. The ANSIRH study encompassed only complications that had been labeled with a specific abortion-related code. In the larger study, by contrast, researchers included all complications that had been recorded with any code related to pregnancy complications.
The latter approach makes more sense. All the women recorded in that study had indeed had an abortion, regardless of how the visit was coded. Complications following an abortion may fairly be called “abortion complications,” not just “pregnancy complications.” What’s more, the same study found that 60 percent of known chemical abortions in 2015 had been miscoded as miscarriages. Considering these facts, it’s clear that using only abortion-related diagnostic codes, what with their inconsistent and selective use, is a highly flawed way to track complications from abortion.
Maternal deaths from abortion
Most sobering of all, maternal deaths from abortion may be vastly undercounted due to the various ways “maternal death” can be defined. The CDC’s National Vital Statistics System (NVSS) defines maternal mortality as a pregnancy-related death that occurs within six weeks of the woman’s pregnancy ending. But the agency’s Pregnancy Mortality Surveillance System (PMSS) uses a substantially broader definition: any pregnancy-related death that occurs within a year of the pregnancy ending. On top of that, CDC data comes mostly from death certificates—which do not always document whether the death was related to pregnancy.
Adding to the confusion is the distinction between “pregnancy-associated” deaths and “pregnancy-related” deaths, both of which might be classified under maternal deaths. The former is defined as the death of a woman while pregnant or within one year of the end of pregnancy. This wide definition encompasses even deaths from car accidents, cancer, or homicides—all of which would appear unconnected to the pregnancy.
Deaths that are “pregnancy-related,” on the other hand, must be “from any cause related to or aggravated by the pregnancy or its management, excluding accidental or incidental causes.”
To determine which definition to use, an organization must decide whether the maternal death was caused by the pregnancy. It’s a decision up to the preferences of the organization how to categorize maternal deaths, and that can drastically affect how the data is reported.
More specifically, defining an “abortion-related” maternal death also poses a challenge. The CDC has defined an abortion-related death as “a death resulting from a direct complication of an abortion (legal or illegal), an indirect complication caused by a chain of events initiated by an abortion, or an aggravation of a preexisting condition by the physiologic or psychologic effects of abortion.” Notice that the definition does not include a time limitation—another point of imprecision.
Thus, it's difficult to examine a connection between abortion and maternal mortality when the raw numbers are lacking and the definitions vary. You may have heard the common claim that “abortion is safer than childbirth.” But given the absence of solid data, that claim has no legs to stand on. And many call this claim a “myth.”
Remember that not only is maternal mortality defined by the preferences of organizations; it’s also an overinclusive standard. Definitions of this term refer to deaths within a certain time of a pregnancy “ending,” which can include abortions, miscarriages, and live births. Hence data about abortion-related deaths can remain undistinguished from data on all other pregnancy-related deaths.
By contrast, we’ve seen multiple reasons why abortion data is flawed. If the data regarding abortion is flawed, then the data regarding abortion-related deaths will be too. That category is underinclusive. So while the number of maternal deaths from pregnancy will be overinflated, the number of those deaths attributed to abortion will be underrepresented, making abortion look “safer” than it actually is. It’s clear that comparing the mortality rates of childbirth and abortion is comparing apples and oranges.
In short, we know that every year, some women do tragically die from an abortion. But because of differing reporting standards, inconsistent tracking, and imprecise definitions, we don’t know just how many.
Anyone telling you that abortion-related deaths are “extraordinarily rare” is relying either on flawed or incomplete data.
Chemical abortion drugs: less data, more danger
If we know so little about abortion generally, what do we know about chemical abortion drugs specifically?
It is estimated that 3.7 million chemical abortions occurred in the U.S. between 2000 and 2018. The FDA initially required prescribers of chemical abortion drugs to report adverse events, but the agency dropped the requirements that these prescribers report non-fatal complications in 2016. And the FDA has never required emergency room doctors and other medical professionals to report any complications that they treat for chemical abortion drugs. But two analyses of the FDA’s mandated adverse event reports (AERs), conducted from 2000 to 2019, revealed only 3,804 AERs. If that number seems suspiciously small, that’s because it is.
Planned Parenthood—which has no incentive to inflate the numbers of adverse events—published a study in 2013 reporting 1,530 events over a two-year period. The numbers just do not line up.
Furthermore, many women do not visit their abortion providers for a follow-up after taking chemical abortion drugs. Instead, they go straight to the emergency room if they have complications. The FDA reported that abortion providers performed less than 40 percent of surgeries required for failed chemical abortions. So in many cases, abortion providers such as Planned Parenthood are not even the ones to treat women who have experienced complications. They may not even be aware that the complications occurred.
Even more concerning is that complications from chemical abortions among minors have been completely unstudied. The FDA disregarded its own rules when approving mifepristone, the first drug in the regimen, by not requiring a safety assessment of the drug specifically on girls under the age of 17—even though FDA’s approved regimen has no age restrictions. To this day, the FDA has flouted its legal obligation to know the short-term and long-term safety implications for girls who take chemical abortion drugs.
Data aside, chemical abortion drugs are downright dangerous. Before we can begin to discuss the dangers, however, we must note that even the “normal” side effects are serious. The average woman will bleed for well over a week after taking chemical abortion drugs, and 8 percent will bleed for over a month. Most women will experience cramping, nausea, fever, vomiting, diarrhea, and a host of other symptoms.
The “real” complications are far more alarming. The American College of Obstetricians and Gynecologists (ACOG) has identified low hemoglobin; severe liver, renal, or respiratory disease; uncontrolled hypertension; and cardiovascular disease as conditions that can cause chemical abortion drugs to be particularly dangerous.
Even for women who have none of those conditions, mifepristone poses a danger. The pharmacological effects of the drug (how it directly affects the body’s cells and organs) are serious. Mifepristone works by cutting off the supply of necessary hormones to the uterus. By its regular working, the drug may predispose women to excessive blood loss, increase the risk of infection and sepsis, and even contribute to depression and anxiety.
That’s when the drugs “work.” But what about when they “fail,” that is, when they either do not end the life of an unborn child or do not fully expel the baby and placenta from the uterus? One international review of 45,000 abortions found that 5 percent of chemical abortions still required surgery and that 1 percent failed to end the unborn child’s life. A second review of 18,000 chemical abortions found that 8 percent of first-trimester abortions failed and required surgery. And if an abortionist miscalculates the gestational age of the unborn baby, or prescribes chemical abortion drugs off label and beyond the FDA-approved 10-week limit, the risk for complications increases. Among second-trimester abortions, the number of failed chemical abortions requiring surgery skyrocketed to 38 percent.
But are complications such as these worse in chemical abortions than in surgical abortions? The overwhelming answer is yes. For example, ER visits that are correctly coded as abortion-related are twice as high for chemical abortions as for surgical abortions.
Conclusion
So is abortion safer than Tylenol? To answer that question, let’s ask a few others. How often does taking the proper dose of Tylenol result in an emergency room visit? How often does it require surgery? How often does it lead to sepsis? How often does it cause weeks-long bleeding?
To ask these questions is to answer them. The FDA’s chemical abortion drug regimen is simply not safe, and arguments to the contrary are not rooted in sound science.
Read more about ADF’s first-of-its-kind lawsuit against the FDA here.
