The medical dangers and risks of medication-induced abortions

By Dr. Ana Sanguineti, Pro-Life Spokesperson for the Diocese of Tucson 

In August of this year, a significant victory occurred in the ongoing battle to protect the health and safety of women and children. The United States Court of Appeals for the Fifth Circuit ruled that the abortifacient, Mifepristone, cannot be mailed to pregnant women seeking a chemical abortion. In addition, some previous restrictions and guidelines that had been eliminated by the FDA were restored for the use of this chemical. 

If this ruling is upheld, it will help to reduce the number of abortions currently taking place. As the lawsuit filed against the FDA and its approval of Mifepristone makes its way through the courts, at stake are the lives of countless babies in the womb and the health of the women who carry them. It is important to understand this dangerous chemical - how it works, what are its side effects and complications, and what is the history of Mifepristone. 

History of Mifepristone Use 

Mifepristone, an antiprogestin chemical, was first approved in the United States for use in ending the life of a baby in the womb in 2000. While the FDA limited its use to the first 7 weeks of gestation, it carried a Black Box Warning noting the chemical’s serious side effects. In 2005, the FDA issued a Public Health Advisory for Mifepristone because of incidents of serious infections or sepsis. The Black Box Warning was revised (1). In 2011, the FDA developed a Risk Evaluation and Mitigation Strategy Program (REMS) to specify guidelines for its use. Here’s what they wrote: “The goal of the Mifeprex REMS Program is to minimize the risk of serious complications” (2). 

Side Effects of Mifepristone/Mifeprex 

• Bleeding that can be heavy, excessive and prolonged, even resulting in hemorrhaging. 
• Infections and sepsis. 
• Severe abdominal pain after Misoprostol is taken as part of this regimen. 
• Nausea, vomiting, headaches and weakness that can lead to “passing out”. 

The side effects associated with this chemical can mask the symptoms of an impending rupture of an Ectopic Pregnancy, leading to a surgical emergency. 

Black Box Warning 

This warning emphasizes the occurrence of “serious and sometimes fatal infections” that can present in an atypical manner. It also warns of the risk of prolonged and heavy bleeding. 

REMS Program 

In 2011, the use of Mifeprex was limited to 49 days gestation of the pregnancy, with a physical exam, under the supervision of a healthcare provider, for 3 visits. 

In 2016, the goal of REMS was modified and clearly stated: to mitigate the risk of serious complications associated with Mifeprex (3). The drug could only be dispensed in clinics, medical offices and hospitals under the supervision of a certified prescriber. Retail pharmacies were not allowed to dispense Mifeprex.  

By 2023, Mifeprex (and its generic counterpart, Mifepristone) became more readily available through the removal of the requirement for an office visit and exam prior to taking the pills; allowing pharmacies to dispense the drug; promoting the mailing of this drug; and increasing its use to 70 days gestation. 

From this history, we see that Mifepristone has long been known to have serious side effects. A Black Box Warning has been present to warn of these dangers. A strategic program (REMS) was needed to try and minimize the serious complications of this drug. 

This tells us that this chemical and the regimen for chemical abortions can have dangerous consequences to the health of the woman taking it. 

Why does this matter? 

Chemical abortions have gained popularity as a way of circumventing the US Supreme Court decision to overturn Roe v. Wade and return the issue of abortion to each State. But this use of the chemicals Mifepristone and Misoprostol is dangerous to the pregnant woman, and the relaxation of the restrictions on its use has made it more risky.  

Furthermore, women taking these pills are no longer medically supervised, are often alone and may not understand the full implications of taking these chemicals. If the proponents of Mifepristone don’t care about a woman’s health, why would you trust them with ANY statement that minimizes a woman’s risk with chemical abortions? Rather, shouldn’t we help an expectant mom with the assistance she needs to bring her baby into this world, safe and healthy?  

Mailing harmful chemicals to women without physician involvement, to promote abortions, even when prohibited by that state, results in great threat of harm to the woman's health. The chemical regimen used to abort the developing child in the womb has resulted in a 500% increase in emergency room visits over the past decade for the treatment of its severe side effects (4). And, it is dangerous to take if an ectopic pregnancy is present.   

Chemical abortions, indeed ALL abortions, harm women and cause them to be abandoned in their pain. They are an affront to a woman's dignity, an attack on her life-bearing gift and on our most vulnerable children in the womb.   

There is much more work to be done to end abortions altogether and safeguard a woman's health and a baby's life. We must continue with prayer for vulnerable women and in compassionate service to expectant moms and children as our Catholic faith requires, so that abortion becomes unthinkable. 

 

1. https://webarchive.loc.gov/all/20081026174111/http://www.fda.gov/cder/foi/label/2005/020687s013lbl.pdf  page 1. Mifeprex Label;FDA Warning. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s025Lbl.pdf 

2. REMS; https://www.fda.gov/media/164648/download?attachment NDA 20-687 MIFEPREX Tablets;Danco Laboratories,LLC 

3. REMS; https://www.fda.gov/media/164649/download?attachment Ref ID: 3909592 

4. Abortion Drug Facts; Charlotte Lozier Institute; Risks to Women; https://lozierinstitute.org/abortion-drug-facts  and 
   JStudnicki et.al. A Longitudinal Cohort Study of ER Utilization Following Mifepristone Chemical and Surgical Abortions,1995-2015; Nov9,2021  
   https://doi.org/10.1177/23333928211053965 or  https://journals.sagepub.com/doi/10.1177/23333928211053965  
   see also
    https://webarchive.loc.gov/all/20081026174028/http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone_historical.htm