The abortion industry claims that abortion pills are safe. Yet peer-reviewed science and data say otherwise. Research shows the rate of abortion pill-related emergency room visits has increased more than 500% over the past decade and a half, and that abortion pills put mothers at significantly greater risk for complications.

Source: https://lozierinstitute.org/public-health-threat-chemical-abortion-leads-to-significantly-higher-rate-of-er-visits/

The abortion industry is battling to move the frontlines in the fight for life from the sidewalk to the mailbox, with  “mail-order abortions” as the standard and no in-person medical oversight.  Not only will this lead to the deaths of more unborn babies – it also puts the health of women at greater risk.

For two decades the U.S. Food and Drug Administration (FDA) had safety protocols to mitigate the risks from these abortion drugs. While requirements to report complications were weakened in 2016 under the Obama Administration, the reality America faces today is the Biden administration’s abandoning long-standing safety measures by legalizing mail-order abortion.

The FDA's Dangerous, Unscientific Abortion Decision

This latest move puts the lives of babies and their mothers at risk.  Charlotte Lozier Institute is ready for the fight.  We will continue to conduct original, peer-reviewed, data-supported science for the benefit of women who are being targeted by the abortion industry.  Where our opponents rely on a false narrative of safety and even encourage women to lie to emergency room (ER) doctors if they do suffer complications, we will rely on the science, the data, and sound medicine.

 

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Risks to Women

Chemical abortion is dangerous. Studies have found that chemical abortion has four times the complication rate of surgical abortion, and these risks only increase with advanced pregnancy and lack of medical supervision.

  • Rolling back safety protocols (REMS) will put women at risk of complications and abuse. Read the fact sheet and the primer.

  • With no medical oversight, abortion pills can fall into the hands of traffickers and abusive partners. Already, there are accounts of women being given abortion pills without their knowledge and against their will. The risk of forced abortions has increased now that the pills are available online without an in-person visit with the woman’s doctor.

  • A peer-reviewed study of 423,000 abortions in U.S. states that paid for abortions with state tax dollars found that the rate of chemical abortion-related ER visits increased more than 500% from 2002 to 2015. Chemical abortions had higher ER visit rates than surgical abortions. The study also found that more than 60% of chemical abortion-related ER visits in 2015 were miscoded as miscarriages – meaning these complications could go unrecognized.


    Source https://pubmed.ncbi.nlm.nih.gov/19888037/

  • U.S. abortion data is generally very poor. A key analysis of abortion pill-related adverse events submitted to the FDA shows significant underreporting – and with the FDA only collecting data on deaths, reports of non-fatal but life-threatening complications are increasingly missing. Even with the poor data there is enough to show multiple deaths and hundreds of serious complications resulting from chemical abortion. FDA’s own data shows that chemical abortion has resulted in at least 24 deaths and thousands of adverse events since the drug was first approved.

  • The risks of chemical abortions aren’t just physical: women have described that their chemical abortion experiences left them feeling unprepared, silenced, regretful, or left with no other choice.

  • While abortion advocates argue that chemical abortion is so safe and efficacious that it can be self-prescribed and self-managed, a more comprehensive analysis of several studies shows that chemical abortion is often used contrary to women’s self-determination and best interest; that complications data show real harms to women physically and psychologically; and that the role of physicians in pre-screening and counseling should be increased, not eliminated.  

  • The risks and complications of chemical abortion will likely increase due to the reckless push by abortion advocates for wide-scale distribution of the abortion pill through the mail. Without proper medical examination before chemical abortion, a woman may be in grave danger from an undiagnosed ectopic pregnancy, the use of the abortion drug dangerously late in pregnancy, Rh-factor incompatibility that could put future pregnancies at risk, and reproductive coercion.

  • The FDA has failed to respond to these concerns. In fact, some abortion providers have skirted the law and sent drugs through the mail that have serious quality issues.

  • Medical groups filed a Citizen Petition with the FDA, highlighting these concerns and asking the FDA to protect women’s health and uphold the REMS safety protocols.

How Chemical Abortion Works

Chemical abortion is a two-drug process involving mifepristone and misoprostol. The first drug, mifepristone, is often called the “abortion pill” and works by blocking progesterone, a hormone necessary for sustaining the pregnancy. This results in the death of the unborn baby. 

"One of the best studies…found that the chemical abortion patients had four times the complication rate than the surgical abortion patients." - Dr. Donna Harrison, M.D.Source
Mifepristone is then followed by misoprostol, which induces contractions to expel the unborn baby and other pregnancy tissue from the uterus. The FDA lists the following side effects of Mifeprex (the brand name for mifepristone): cramping, bleeding, nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. A black box warning on Mifeprex highlights the risk of serious and sometimes fatal infections or bleeding, and that deaths have been reported. The FDA also notes that “you may see blood clots and tissue. This is an expected part of passing the pregnancy.”

  • Mifepristone was first invented and tested by French company Roussel-Uclaf in the 1980s.

  • To separate itself from controversy over the abortion drug, Roussel-Uclaf donated U.S. patent rights for mifepristone to the Population Council. 

  • The Population Council began working to get FDA approval of mifepristone, sponsoring a large trial of the drug in the U.S.

  • The Population Council licensed mifepristone to Danco, a shell company created for the purpose of distributing the drug in the United States. Because Danco has no products but mifepristone, the company is immune from the effects of boycotts and faces little accountability. Danco sells mifepristone under the brand name Mifeprex.

  • In 2019, GenBioPro received FDA approval to distribute a generic version of mifepristone. Like Danco, GenBioPro is a one-drug company that sells nothing but mifepristone.

Online Access

Despite a previous FDA requirement for mifepristone to be administered in person, abortion businesses and online pharmacies such as Aid Access have been mailing abortion pills directly to consumers for years, putting women at greater risk of harm.

In July 2020, the abortion industry took advantage of the COVID-19 pandemic by obtaining a court order to block the FDA requirement that mifepristone be administered in person. The Supreme Court stayed the court order allowing safety protocols to remain, but by April 2021, the FDA announced it would be suspending enforcement of its requirement for an in-person visit prior to obtaining the chemical abortion drug.  Under this new rule, women are only supposed to use abortion pills approved by the FDA in the U.S.  But abortion pills from outside the U.S. are easily accessible and dangerous, putting women at even greater risk.

  • A 2017 study by researchers who support abortion tested samples of chemical abortion pills purchased online from outside the U.S. Their study found that none of the websites required a prescription to place the order; none of the mailed packages contained any patient instructions or information; several drug packages arrived with damage including pinprick holes in the foil of the blister pack; and testing revealed that the contents of the pills were inconsistent from sample to sample, with one-quarter of samples containing under half the recommended dosage. The study neglected to test for any contaminants or fillers in the pills.  Incredibly, the pro-abortion researchers ignored these troubling findings and instead concluded there was no evidence that the online mifepristone and misoprostol drugs were dangerous or ineffective.

  • In 2018, an online review found at least 72 websites selling chemical abortion kits directly to consumers – some as generic online pharmacies and others as abortion-centered businesses. More than one-third of the websites mentioned FDA approval of the abortion drugs, 20 websites did not refer to a gestational age by which the drugs should be taken, most did not ask for any medical information, and some websites advertised bulk orders of 4, 5, and even up to 9 chemical abortion “kits” bundled in one purchase.

  • Since April 2021, the FDA has suspended its enforcement of an in-person medical visit for women seeking a chemical abortion. However, even before that time, groups like Aid Access and a clinical trial known as the Telabortion Project run by Gynuity Health Projects circumvented the FDA’s safety protocol by mailing abortion pills directly to women, putting them at greater risk of complications (this trial is no longer enrolling participants since September 2021, and has published its findings). By 2019, Aid Access had mailed more than 7,000 abortion pill packages to American women, and likely mailed many more since then.

  • Even before the FDA waived its in-person visit requirement for Mifeprex, multiple instances were reported in which women’s abusive partners were able to obtain Mifeprex abortion pills and administer them to women without their knowledge or consent. 

  • Following the FDA’s suspension of the in-person requirement, several abortion pill start-ups have opened for business, and online pharmacies have started to mail abortion pills across the country.

  • Altogether, these online abortion pill distributors advertise that they ship to more than half the country. 

Abortion Pill Reversal
24/7 Helpline: 877.558.0333

With the rise of chemical abortion, a growing number of women have changed their minds after taking Mifeprex/mifepristone, the first of the two drugs in the chemical abortion process, and do not want to harm their baby. Abortion Pill Reversal (APR) is an effective medical protocol capable of reversing the effects of mifepristone through the use of the pregnancy hormone progesterone. The APR protocol is administered by physicians throughout the U.S. Multiple studies conducted throughout the world have produced positive results using progesterone treatment in pregnant women who have recently taken the first abortion pill.

Abortion Pill Reversal Logo

As of January 2022, more than 3,000 babies’ lives have been saved after women chose to begin the APR protocol! A 2018 peer-reviewed study on APR that followed 754 women who wanted to discontinue their chemical abortions revealed that, when administered within 72 hours of taking mifepristone, the APR progesterone protocol has a 64-68% success rate in saving unborn babies. It also found no increased risk of birth defects or preterm births.

State Action

States that do not allow abortion-by-mail

States that ensure a woman receives a physical exam before a chemical abortion

 

Federal Action

For two decades, the U.S. Food and Drug Administration (FDA) regulated the chemical abortion drug Mifeprex (mifepristone) with a requirement that it be dispensed in-person by a certified prescriber. Seizing the COVID-19 public health emergency as cover, the Biden Administration temporarily suspended enforcement of this requirement in April 2021, and in December 2021 announced that the in-person dispensing requirement would be permanently removed.

  • September 2000

    Under the Clinton administration, the FDA approved RU-486 (Mifeprex) for use up to 49 days of pregnancy with safety restrictions, including the requirement for in-person administration of the drug by a certified provider. It also required follow-up visits to ensure the woman’s safety and completion of the abortion, and required all serious adverse events be reported to the FDA by Danco, the manufacturer of the abortion pill.

  • 2006

    In response to the deaths of four women from a rare bacterial sepsis, the FDA and CDC convened a workshop in which they concluded that mifepristone’s alteration of the immune system could impair the body’s ability to respond to C. sordellii toxin, a common bacteria found in soil.  

  • 2011

    The FDA issued updated guidelines altering how the drug may be distributed and how complications are reported. The FDA also approved the Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex, incorporating the existing restrictions into the new, formal 2011 REMS. 

  • 2016

    The FDA updated the Mifeprex label and weakened its REMS safety protocol: It extended the approved use from 49 days gestation to 70 days gestation; changed the recommended dosage for the drug; allowed non-physicians to distribute the drug; and required only deaths to be reported to the FDA (no longer requiring reporting of severe adverse events). 

  • March 2019

    The FDA issued warning letters to two companies illegally distributing Mifeprex online, Aid Access and Rablon. Because of safety concerns, the FDA warned the companies were in violation of the Federal Food, Drug, and Cosmetic Act by “introducing into interstate commerce misbranded and unapproved new drugs,” and requested a response within 15 days. Aid Access issued a response letter stating that it would not stop mailing chemical abortion drugs, and also filed a lawsuit against the FDA which was ultimately dismissed by a district court. No further FDA response has been published at this time.  These drugs remain available through the internet.

  • April 11, 2019

    For the first time, the FDA approved a generic version of Mifeprex, determining that the mifepristone tablet (200 mg) is equivalent to Mifeprex and can be substituted for it. The generic mifepristone is produced by a company named GenBioPro, which only makes mifepristone.

  • April 13, 2021

    The FDA announced the temporary suspension and enforcement of its requirement for women to make an in-person medical visit prior to starting a chemical abortion, for the duration of the COVID-19 public health emergency. Read Charlotte Lozier Institute’s fact sheet and press release.

  • December 16, 2021

    The FDA announced its decision to officially remove the in-person screening requirement from the REMS, allowing mifepristone to be available by mail, and created a new certification to allow pharmacies to dispense the drug. For an analysis of the decision explaining data and reporting on complications, see https://lozierinstitute.org/analysis-fda-decision-ignores-data-on-complications-puts-women-at-risk/

  • December 16, 2021

    The FDA published an updated Post-Marketing Adverse Events Summary summarizing complications of chemical abortion reported through June 30, 2021. https://www.fda.gov/media/154941/download

  • December 2021

    A December 2021 peer-reviewed study found that the number of adverse events available on the FDA’s Adverse Event Reporting System for 2009-2010 was less than half the amount of adverse events identified by a Planned Parenthood study covering the same time period – demonstrating that the FDA’s database, which the FDA relied upon for its decision to remove the in-person screening, is “inadequate to evaluate the safety of mifepristone.” https://journals.sagepub.com/doi/10.1177/23333928211068919

For more information on the FDA REMS drug safety program for Mifeprex and mifepristone, please see: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=390 

For more information on the FDA’s approval of Mifeprex, please see: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_mifepristone.cfm 

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