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Charlotte Lozier Institute

Phone: 202-223-8073
Fax: 571-312-0544

2776 S. Arlington Mill Dr.
#803
Arlington, VA 22206

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Charlotte Lozier Institute

Phone: 202-223-8073
Fax: 571-312-0544

2776 S. Arlington Mill Dr.
#803
Arlington, VA 22206

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Abortion
Drug Facts

The abortion industry claims that abortion drugs are safe. Yet peer-reviewed science and data say otherwise. Research shows that, compared to surgical abortion, live birth, or an emergency department visit at any time by women who were never pregnant, emergency room visits after the use of abortion drugs are significantly more likely to be severe and complex, and that abortion drugs put mothers at significantly greater risk for complications.

Abortion Pill Reversal 24/7 Helpline Run by Abortion Pill Rescue Network: 877.558.0333

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

From 1999 to 2019, 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, America now faces the consequences of the Biden administration’s abandonment of long-standing safety measures by legalizing mail-order abortion.

                                                                Article published December 17, 2021

These changes have put the lives of babies and their mothers at risk, but Charlotte Lozier Institute is ready for the fight. We will continue to conduct original, peer-reviewed, data-supported scientific research for the benefit of women who are being targeted by the abortion industry, which relies on a false narrative of safety and even encourages women to lie to emergency room (ER) doctors if they do suffer complications.


DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Risks to Women

Abortion drugs are dangerous. Studies have found that drug-induced 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 critical safety protocols included in the Risk Evaluation and Mitigation Strategy (REMS) has put women at risk of complications and abuse.
  • With no medical oversight, abortion drugs can fall into the hands of traffickers and abusive partners. Even prior to the 2021 FDA decisions that removed in-person screening and dispensing requirements, there were already accounts of women being given abortion drugs without their knowledge or consent. The risk of forced abortions has increased now that these drugs are available online without an in-person visit with the woman’s doctor.
  • Approximately 3-7% of the time, abortion drugs will result in an incomplete abortion requiring additional drugs or surgery, and this rate increases the later in pregnancy the drugs are used. The FDA’s own label indicates that around one in 25 women will end up in the emergency room after using abortion drugs. Worse, the overall incidence of adverse events following drug-induced abortion has been found to be 20% – four times the rate of adverse events following surgical abortion.

    Source: https://pubmed.ncbi.nlm.nih.gov/19888037/
  • U.S. abortion data is generally very poor. A key analysis of abortion-drug-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. Furthermore, the FDA relied on flawed research to permit mail-order abortion. Even with the poor data, however, there is enough to show multiple deaths and hundreds of serious complications resulting from drug-induced abortion. The FDA’s own data shows that drug-induced abortion has resulted in at least 36 deaths and thousands of adverse events since the drug was first approved.
  • The risks of drug-induced abortions aren’t just physical: women have described that their drug-induced abortion experiences left them feeling unprepared, silenced, regretful, or left with no other choice.
  • The risks and complications of drug-induced abortion will likely continue to increase due to the wide-scale distribution of abortion drugs through the mail. Without proper medical examination before drug-induced abortion, a woman may be in grave danger from an undiagnosed ectopic pregnancy, the use of abortion drugs dangerously late in pregnancy, Rh-factor incompatibility that could put future pregnancies at risk, and/or reproductive coercion.
  • Because of these risks, an alliance of doctors and medical groups sued the FDA to restore important safeguards or even take the dangerous drugs off the market entirely. Lower courts found their arguments persuasive, but they were overruled by the Supreme Court on technical grounds. However, a group of states has continued the litigation to protect their citizens from the risks of mail-order abortion.

DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

How Drug-Induced Abortion Works

Drug-induced 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.

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 potential 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 pharmaceutical 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 Laboratories, a shell company created for the sole 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.

DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Online Access

With the rollback of the in-person dispensing requirement, abortion drugs are widely available online and through the mail. This is the culmination of years of effort on the part of the abortion industry.

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 mifepristone. Under this new rule, women are supposed to only use abortion drugs approved by the FDA in the U.S. But abortion drugs from outside the U.S. are also easily accessible, putting women at even greater risk.

  • A 2017 study by researchers who support abortion tested samples of abortion drugs 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.
  • In 2018, an online review conducted by CLI found at least 72 websites selling drug-induced abortion “kits” directly to consumers – some as generic online pharmacies and others as abortion-centered businesses. Some websites advertised bulk orders of four, five, and even up to nine drug-induced abortion kits bundled in one purchase.
  • Following the removal of the in-person requirement, websites sprang up to mail abortion drugs across the country. These online abortion drug providers are driving abortion numbers up in the U.S.
  • As a result of so-called “shield laws” passed by pro-abortion states, which provide cover to abortionists illegally mailing abortion drugs into pro-life states, abortion drugs are available in every state. Read the article: https://lozierinstitute.org/abortion-shield-laws-pro-abortion-states-seek-to-force-abortion-on-life-affirming-states/

DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Abortion Pill Reversal

24/7 Helpline: 877.558.0333

CHAT NOW

A growing number of women have changed their minds after taking mifepristone, the first of the two drugs in the abortion drug 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.

According to the Abortion Pill Rescue Network, as of March 2025, more than 6,000 babies’ lives have been saved after women chose to use the APR protocol. A 2018 peer-reviewed study on APR that followed 754 women who wanted to discontinue their 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.


DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

States that do not allow abortion-by-mail


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



DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Federal Action

For two decades, the U.S. Food and Drug Administration (FDA) regulated the 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 that all serious adverse events be reported to the FDA by Danco, the manufacturer of the abortion drug.

July 2005

The FDA and CDC issued a public health advisory regarding the deaths of four women in the U.S. following drug-induced abortions with Mifeprex and intravaginal misoprostol. Two of the deaths occurred in 2003, one in 2004, and one in 2005. The women had clinical illness consistent with Clostridium sordellii (C. sordellii), a rare, fatal cause of toxic shock syndrome.

May 2006

In response to the deaths of these four women from sepsis caused by C. sordellii, 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 changing how the drug could be distributed and how complications would be 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: extending the approved use from 49 days (7 weeks) gestation to 70 days (10 weeks) gestation, changing the recommended dosage for the drug, allowing non-physicians to distribute the drug, and requiring only deaths to be reported to the FDA (no longer requiring reporting of other severe adverse events).

March 2019

The FDA issued warning letters to two companies illegally distributing mifepristone 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 abortion drugs and also filed a lawsuit against the FDA which was ultimately dismissed by a district court.

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 12, 2021

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

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 2021

A 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

January 2023

The FDA officially updated the mifepristone REMS to reflect the elimination of the in-person dispensing requirement. Additionally, the FDA allowed pharmacies to become certified prescribers of abortion drugs.

 

 


DISCLAIMER: THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE
The information, including but not limited to, text, graphics, images and other material contained on this website are for educational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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