The “abortion pill” has come under fire over the past year, in both the courts and the media. The two sides of the proverbial aisle paint this drug with contradictory characters, either championing it as perfectly safe or condemning it as practically deadly. In the middle of this competing rhetoric, we’re losing key information about what the “abortion pill” is, leading to situations where women are critically underserved or, at times, even in danger. But if we look past the rhetoric to understand the nuance surrounding this medication, we can paint a more accurate picture of the “abortion pill” and provide better care for women.
What Is the “Abortion Pill”?
Despite the name, the “abortion pill” is normally not a single medication; it is typically administered as a set of two medications, taken in series. The first pill is mifepristone and the second is misoprostol.
Mifepristone acts as a progesterone receptor antagonist, meaning that it blocks the effects of progesterone, a critical hormone for maintaining pregnancy. Mifepristone also induces other effects, including increased uterine contractions and death in decidual tissues, which make up part of the placenta.
Misoprostol, which is taken after mifepristone, further induces contractions to remove uterine contents. Misoprostol may also be taken as a single medication, though this is less common.
Discussions around abortion and “abortion pill” regulation typically center on mifepristone because the FDA approved it specifically as an abortifacient in 2000. In contrast, misoprostol was originally approved in 1988 for prevention of gastric ulcers. Because of this, misoprostol does not have the same legal requirements for regulation, although patients may receive questions at the pharmacy about reasons for use.
Due to the legal complexity surrounding it, mifepristone will be the focus of this article.
Mifepristone’s Political Status Limits its Accessibility for Women Suffering Miscarriage
Just as the phrase “abortion pill” inaccurately describes the two-medication regimen, it also does not fully encompass mifepristone’s clinical uses.
While the mifepristone/misoprostol drug combination has only been approved by the FDA for medication abortions, the two drugs are also used in other medical contexts. “Off label” use of FDA-approved medications is permitted by the FDA, and a number of drugs are commonly prescribed off label.
Of particular note is the use of mifepristone after a miscarriage. Using mifepristone as part of post-miscarriage care has been demonstrated to be more effective than misoprostol alone. And, because approximately 10-15% of pregnancies result in a clinically recognized miscarriage, mifepristone is potentially applicable to a large number of clinical situations. However, due to its FDA approval status as an abortifacient, the drug has regulation and access barriers that limit why physicians are able to dispense it. As a result, women who have experienced miscarriage often have difficulty accessing this medication.
Because mifepristone has been approved for elective abortions, it is possible that changes in legislation that limit access to the drug may also limit access for other medical needs.
Alabama and Arizona are among the first states to call for a nearly complete ban on access to mifepristone in the past year. Additionally, a lawsuit was filed in Texas against the FDA, calling for the overturn of their decision to approve mifepristone. This lawsuit was filed in November by the Alliance for Hippocratic Medicine (AHM), an organization composed of several largely Christian medical associations, including the Catholic Medical Association. The group claimed in their motion that the 2000 accelerated approval of the drug was unlawful and put women at serious medical risk. In April of this year, the judge ruled to hold mifepristone’s status of FDA approval, introducing the possibility of removing mifepristone access in the United States because of its abortifacient classification. Notably, the drug’s use in miscarriage management was not mentioned in the judge’s official Memorandum.
In response to this decision, the Supreme Court has ruled to temporarily protect mifepristone access while the appeals process plays out. It seems likely that this case will return to the Supreme Court later this year, where a final verdict will be made. The outcome of these legal battles will play a critical role in establishing physicians’ avenues of care for patients of all kinds, and wholesale restriction on these medications may leave physicians and pharmacies treating early pregnancy loss with few options.
Because of this possibility, the American College of Obstetricians and Gynecologists (ACOG) – along with 48 other organizations including the American Medical Association (AMA) – submitted a Citizen Petition to the FDA in October, calling for approval of mifepristone for miscarriage management. The outcome of this petition, and the impact of state-by-state legislation on access to these drugs, remains to be seen. The ACOG and AMA have also provided amicus briefs on behalf of the FDA in the current court case. In the event that FDA approval of mifepristone is reversed, there are limited circumstances under which physicians may still prescribe it. How these circumstances would apply to mifepristone, particularly in cases of pregnancy loss, is a matter for future discussion.
Changes in Mifepristone Access May Lead to Unregulated Administration, Putting Women at Risk
While mifepristone is currently approved by the FDA, like many drugs, there can be risks involved in using it, as well as circumstances under which it would be ill advised or dangerous to do so.
Because of this, the FDA requires that physicians fulfill certain certification requirements before being able to prescribe it (in the mifepristone/misoprostol combination form) so they know what to look out for as potential risk factors for their patients. As part of that certification, prescribers are required to read Prescribing Information on Mifeprex, which provides directions for administration, information on drug interactions, and risk factors (discussed below). Physicians are also required to submit a Prescriber Agreement Form to obtain certification, acknowledging that they understand the risks of the medication and have the ability to assess those risks and provide medical intervention if necessary. When physicians prescribe mifepristone with misoprostol to a patient, they must go over a Patient Agreement Form to ensure that the patient also knows what the risks are.
In the wake of post-Roe legal changes to drug access, there is some concern that women will seek these medications without physician oversight, either for elective abortion purposes or for other medical reasons. Without a physician/patient interface, drug administration without assessing risk factors and without appropriate knowledge of potential complications is a real possibility. A recent review by physicians at MedStar Washington Hospital Center and Georgetown University outlines these risks and complications, particularly for physicians in emergency departments who may be treating women who have self-administered the medications.
One of the primary concerns is diagnosing ectopic pregnancy, a life-threatening condition that requires early detection and intervention. Women using IUDs are at particular risk for ectopic pregnancy. Other risk factors include a history of bleeding disorders or use of anticoagulants/antiplatelet drugs, as this may result in serious or life-threatening bleeding with drug administration. Mifepristone/misoprostol use also comes with its own risks, particularly the possibility of infection if uterine clearing is incomplete. Lack of follow-up with a physician may preclude infection treatment, leaving women at risk for sepsis. There are also some risks associated with overdose of these medications, but overdose data are currently limited.
Furthermore, acquiring these medications from a non-healthcare source introduces the possibility of taking counterfeit, mislabeled, or contaminated medication. The FDA strongly cautions against purchase of mifepristone over the Internet because “drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.” The safety and efficacy of any off-market drugs cannot be guaranteed, and the source of a drug should be considered carefully before use.
Mifepristone is Currently Underexplored in Other Medical Contexts, Limiting Women’s Treatment Options
FDA regulations on mifepristone also limit its potential for use in other diseases. In addition to mifepristone’s established uses in elective abortion and management of early pregnancy loss, it has also been FDA approved for treatment of Cushing’s disease, and has been researched for treatment of a number of gynecologic uses, including breast and ovarian cancers and endometriosis. However, it has not been widely used in treatment of these diseases, in part due to current access restrictions.
Mifepristone has also been studied for potential application in non-gynecological diseases such as insulin resistance, glaucoma, and various psychiatric diseases. Because the dosages studied for these diseases are lower than what is currently available to clinicians, it cannot be prescribed off label for these conditions. As a result, clinical research studies for these applications are only preliminary. Important considerations for further scientific study and clinical use include the potentially contraceptive impact of mifepristone on the woman’s reproductive cycle at lower dosages, as well as the effects of long term exposure to the medication. Both of these considerations require more extensive study and serious thought when mifepristone is explored as a medical intervention.
Women’s Experiences of Pain Have Been Overlooked in Conversations About Mifepristone
While FDA documentation describes the medical risks involved in taking mifepristone, the experience of taking the medication – including pain and pain management – appears to be largely absent.
The “Prescribing Information” notes the possibility of serious pain, but does so primarily as an indicator of infection or ectopic pregnancy, rather than a symptom on its own. The document also states that “abdominal pain/cramping is expected in all medical abortion patients and its incidence is not reported in clinical studies.”
Indeed, the Medical Review document submitted as part of the 2016 FDA approval of the current medication abortion regimen reports on page 69 that only two of the clinical studies submitted in support of approval reported on the pain experiences of participants. The Medical Review also states that abdominal pain “should only be considered adverse events if the amount of … pain exceeds what would be expected for such a process.” While guidelines of what qualifies as excessive pain would be critical information for physicians and patients, there is no indication in this document that any such delineation was probed in clinical studies – and the statement was not elaborated. The Prescriber and Patient Agreement Forms also offer no such guidelines, nor do they offer recommendations for patient pain management.
The lack of standard guidelines on pain management leads to inconsistent practices for patient counseling and treatment. As a result, some women find a disconnect between the information they receive at the clinic about taking the drug and what they actually experience. In a recent survey conducted by FemCatholic, women recounted their experiences with the mifepristone/misoprostol combination medication. Of the women who responded, severe pain and trauma around the event were commonly reported. One woman was told by her doctor that “it would be uncomfortable, but if [she] took it before bed, [she] should be able to sleep through it.” Instead, she experienced hours of what she described as “the worst pain [she’d] ever felt.”
The respondent went on to call for increased dialogue about women’s pain experiences and pain management when taking these medications. She said, “[t]o not acknowledge the range of pain possible from woman to woman is an injustice … It’s as if because not all women have reactions of the same severity, the easier way is just to ignore that it happens at all. It’s also quite possible that the amount of women who do have a severe reaction is higher, but many just do so silently, assuming this is how it’s ‘supposed’ to be. We’ll never know unless we talk about it more.”
So, What’s the Real Story of the “Abortion Pill”?
The “abortion pill” is, in fact, a two-drug combination wherein one drug (misoprostol) is FDA approved for a non-abortion purpose, while the other (mifepristone) is FDA approved for medication abortion. Mifepristone can be used for medication abortion, but is also used to treat other medical conditions. Crucially, its potential to treat other medical issues has by and large gone unexplored due to its association with abortion. Mifepristone’s regulation and access change frequently, impacting patients of all kinds. Taking it comes with serious risks and, when it comes to the women who take it, more can be done to provide adequate counsel and care.
In short: Like most things, the real story is a lot more complicated than what the surface seems to be.