american life league

Brochure Endnotes

1. “Questions and Answers on Mifepristone for Medical Termination of Pregnancy through Ten Weeks Gestation,” U.S. Food and Drug Administration, September 1, 2023, fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation. 
2. “Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation,” U.S. Food and Drug Administration, March 23, 2023, fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation.
3. “The Abortion Pill | Get the Facts about Medication Abortion,” Planned Parenthood, n.d., plannedparenthood.org/learn/abortion/the-abortion-pill.
4. Sarah Kang, “Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2022,” U.S. Food and Drug Administration, May 26, 2023, fda.gov/media/164331/download?attachment. 
5. “Mifepristone (Oral Route),” Mayo Clinic, September 7, 2023, mayoclinic.org/drugs-supplements/mifepristone-oral-route/side-effects/drg-20067123. 
6. “Mifeprex (Mifepristone) Medication Guide,” Food and Drug Administration, March 30, 2016, fda.gov/media/72923/download.
7. “Mifeprex (Mifepristone) Drug Label,” Food and Drug Administration, March 30, 2016, accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf.

Additional Reading from Celebrate Life Magazine

“Abortion Reversal” 

When Sarah DeJulio took the first dose of the abortion pill regimen at the abortion clinic, she wasn’t sure it was the right choice. Thankfully, her mom found the Abortion Pill Reversal network. This service saved Sarah’s daughter and continues to save lives throughout the US. 

“Are Birth Control Pills Abortifacients?” 

Birth control, the morning-after pill, and the abortion pill all kill babies. How they destroy these young lives, however, differs. Learn how contraceptives and abortifacients work within a woman’s body to understand why we oppose their use.  

“Mailing RU-486 Makes Women Patient-Abortionists” 

When the FDA decided to allow women to take the abortion pill at home and away from medical supervision, it increased the drug’s already high risks. This article summarizes an in-depth report on the abortion pill, its history, use, and the dangers it creates for women. 

“There Is Still Time: Reversing the Abortion Pill” 

Young mother Ashley regretted taking mifepristone almost immediately. The abortionist who gave her the abortion pill told her it was too late to reverse it, but she found help from the Abortion Pill Reversal hotline. 

“Telehealth: Planned Parenthood-Style” 

Telemedicine, like most medical innovations, was intended to save and improve lives. Over the last 15 years, Planned Parenthood and other abortion businesses have hijacked this technology to expand their killing machine. Learn how PP continues to use telehealth, politics, and health crises to take advantage of women and grow its deadly business.

Additional Resources

This Is Chemical Abortion is a docuseries from Students for Life of America that explores the reality of chemical abortion. You will hear from a young mother who successfully saved her baby through the Abortion Pill Reversal process. You will also hear from doctors, legal experts, and advocates as they share the truth about the abortion pill. 

I Saw My Baby is a report by Live Action that explains how “self-managed abortions” increase women’s health risks and emotional trauma. It details the abortion pill’s dangers and includes stories of traumatized women who passed and saw their babies’ bodies during the abortion. 

I Saw My Baby|Abortion Pill Stories is a video series by Live Action that presents real stories from women who had a chemical abortion and regretted it. These raw accounts clearly show the trauma the abortion pill creates. 

1st Trimester Abortion|The Abortion Pill|What Is Abortion? by Live Action is a non-graphic video narrated by an OB-GYN and former abortionist that visualizes and explains the abortion pill process. Additional videos in this series cover other common abortion procedures.

What Is Abortion Pill Reversal?

Research shows that a woman may be able to stop her chemical abortion. She can take supplemental progesterone to reduce the effects of mifepristone. The treatment, called Abortion Pill Reversal, can save the baby up to 68% of the time. 

In a statement, the American Association of Pro-Life Obstetricians & Gynecologists addressed common myths about APR. Doctors, it said, have used progesterone for IVF and pregnancy treatments for decades. There is no evidence that it is harmful for women or preborn babies.  

Additionally, mifepristone does not seem to cause birth defects. If the reversal is successful, your baby’s health should not be affected by the abortion pill.  

APR works best when started within 24 hours of taking mifepristone. It can also work up to 72 hours after beginning the medication abortion. Women must start the progesterone treatment before taking misoprostol. 

A woman who regrets taking the abortion pill can call the Abortion Pill Reversal Hotline (877-558-0333). A nurse will connect her to a local doctor or healthcare provider. They will then prescribe the progesterone treatment.  

Why Do Some Sources Say APR Is Unproven?

More than 5,000 women have had healthy babies after using Abortion Pill Reversal to stop their chemical abortions. 

Despite this success, some sources claim APR is unscientific and unproven. 

The American College of Obstetricians and Gynecologists, for instance, published an advocacy page that claims that abortion pill reversal is unethical. It focuses on a 2012 case series that showed that four out of six women who used APR saved their babies. ACOG says this study is not scientific evidence that progesterone can help pregnancies continue after a chemical abortion. 

The page also discusses a 2020 study that ended early because of safety concerns.  

For this research, 10 mothers who regretted starting a chemical abortion received progesterone or a placebo. Researchers found that two-thirds of the women who received progesterone continued their pregnancies. 

Three women in the study went to the hospital for heavy bleeding, which prompted the researchers to end it early. Abortion Pill Reversal opponents often point to this incident as evidence that the treatment is unsafe. 

What they don’t say is that only one of the three women received progesterone, but it wasn’t able to stop mifepristone from killing her child. The abortion caused heavy bleeding, requiring a blood transfusion, but she passed the child’s body without any further complications. 

The other two women, however, took the placebo. Both needed transfusions and additional surgical abortions to remove their children’s bodies. 

Most importantly, heavy bleeding is a common side effect of the abortion pill, not APR. Mifepristone’s medication guide states, “In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C).” 

The ACOG advocacy page barely touches on the more credible and extensive studies that reflect APR’s success. That includes the research (mentioned above) that found that APR saves the baby up to 68% of the time. This 2018 study included more than 750 women. Doctors gave progesterone to mothers who had taken the abortion pill. When given as a shot, the treatment saved 64% of the babies. When given orally, APR saved 68% of the babies. 

Despite claims that APR “is not supported by science,” ACOG admits that progesterone can protect preborn babies from mifepristone. It warns abortionists about a contraceptive called medroxyprogesterone. ACOG says this drug, which contains progesterone, may “increase the risk of ongoing pregnancy” during a chemical abortion. 

The controversy surrounding Abortion Pill Reversal may continue, but its real-life success is undeniable. More than 5,000 babies are living proof that it works.

Abortion Pill “Safety”

Are Chemical Abortions Actually “Safe and Easy”? 

Abortion advocates promote the abortion pill as the easy option. Women are told that the process is simple and that it’s just like a really heavy period or an early miscarriage. Some women feel that taking the abortion pill is “more ‘natural’ and less invasive” than a surgical abortion. 

But this isn’t the experience that many women have after taking the abortion pill. 

Dr. Brent Boles, a practicing OB-GYN, shared his patients’ common experiences with mifepristone: 

[My patients] didn’t expect the bathroom to look like a slaughterhouse from all the bleeding. They didn’t expect to see the formed baby in the toilet. They didn’t expect it to feel like they were in labor for a full day with no epidural. And that’s not every woman’s experience, but it’s common enough that it is manifestly unfair for an abortion provider to tell the patient that she’s just going to have a little bleeding and cramping that’s no worse than a period. 

Planned Parenthood claims that the abortion pill is “safer than many other medicines like penicillin, Tylenol, and Viagra.” But research has found that the rate of complications is four times higher for chemical abortions than it is for surgical abortions. 

Sadly, this misinformation leaves women unprepared for the physical and emotional trauma of their chemical abortion. They deserve to be fully informed about the choice they’re making and everything it involves. 

Most importantly, they deserve to know the truth about abortion and what it does to the child they’re carrying. Both chemical and surgical abortions carry risks for women. But all abortions are ultimately fatal for the preborn children they target. 

Chemical abortions aren’t better because they can happen at home and a woman “just has to swallow a pill.” It doesn’t matter how small the baby is or how far along a woman is in her pregnancy. An abortion is still an abortion, and killing is still killing.  

Understanding the Limits of Adverse Event Reporting

Danco Laboratories manufactures Mifeprex, the brand form of mifepristone. After mifepristone’s approval in 2000, the manufacturer had to report to the FDA any known adverse events from the drug. These reports include hospitalizations, blood transfusions, infections, deaths, and other complications. 

The FDA changed these reporting rules in 2016. Today, deaths are the only events that Danco must report. This change is one reason that abortion pill complications are severely underreported. 

For example, the FDA’s “Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2018” report included: 

• 24 deaths 
• 97 ectopic pregnancies 
• 4,195 adverse events 
• 1,042 hospitalizations 
• 599 blood losses requiring transfusions 
• 412 infections 

These numbers track reported events from September 28, 2000, to December 31, 2018. 

The most recent version of this report, released in 2023, covers adverse events through December 31, 2022. During the four years between this report and the 2018 report, eight more women died after taking mifepristone. But the FDA only recorded an additional: 

• 0 ectopic pregnancies 
• 23 adverse events 
• 7 hospitalizations 
• 5 blood losses requiring transfusions 
• 6 infections 

These numbers and additional studies suggest that adverse event reports may not accurately represent risks. 

Some complications may not be reported as well. Many women don’t tell their prescribing doctor about adverse events. Instead, they go to the emergency room. They may not admit to taking the abortion pill. This excludes their complications from official reports. Even if they do, emergency rooms aren’t required to report these events to the FDA. And prescribing physicians are only mandated to report deaths.

Some organizations even tell women to lie and say they’re having a miscarriage when seeking emergency treatment. These lies further exclude their complications. Worse, these women may not get the correct treatment or may experience further problems, as the doctor won’t have the right information to properly care for them.

Accurate data about abortion pill risks is limited. Major organizations also push dangerous instructions that affect reporting. These factors make the abortion pill’s safety, at best, unclear. 

Why Are Telehealth Appointments Dangerous for Women Taking the Abortion Pill?

Women who don’t see a healthcare professional in person before taking the abortion pill may have higher risks of complications. They may be too far along in their pregnancies to take the drugs or have an ectopic pregnancy, both risk factors for complications. These problems are easy to miss during a telehealth visit.

An ultrasound during an in-person exam, for example, is the only way to make sure the baby implanted in the uterus. A telehealth appointment can’t include an ultrasound. That means the healthcare professional may not catch an existing ectopic pregnancy. This can have dangerous results if the mother then takes the abortion pill.

Taking the drugs while experiencing an ectopic pregnancy has major risks. It may cause ruptures and lead to further problems. At least two women have died from ruptured ectopic pregnancies after taking mifepristone. 

Additionally, research shows that women who take the abortion pill past 10 weeks of pregnancy experience more side effects and a higher risk of complications. 

Healthcare professionals may miss both issues during a telehealth visit. These appointments rely completely on self-reporting. Women may not understand the significance of their symptoms or correctly report their health information. 

For instance, healthcare professionals typically use the first day of a woman’s last period to determine gestational age. A pregnant mother may miscalculate this date if: 

• • She has an irregular period 
  • She had spotting or implantation bleeding in early pregnancy 
  • She misremembers the date
  • Worse, women can lie about how far along they are, which is dangerous for both the mother and her baby. 

An in-person appointment, however, limits these risks. Health professionals can identify these potential problems during their exams. Women are better protected with in-person care. 

Why Are Ectopic Pregnancies a Serious Risk When Taking the Abortion Pill?

The drug label for mifepristone warns that “the treatment procedure will not be effective to terminate an ectopic pregnancy.”  

It also warns that ectopic pregnancies have ruptured after taking the drug. This outcome can be fatal. At least two women have died from a ruptured ectopic pregnancy after taking the abortion pill. This threat is so serious that healthcare providers must be able to diagnose an ectopic pregnancy to get certified under the Mifepristone REMS program.  

Additionally, the symptoms of a ruptured ectopic pregnancy (abdominal pain and uterine bleeding) are the same as abortion pill side effects. Thinking they are from the abortion, women may ignore the warning signs until it’s too late. 

Ruptured ectopic pregnancies can also cause internal bleeding, infection, and permanent damage to a woman’s reproductive organs. Proper ectopic pregnancy screening is crucial to protect women’s health. 

What Are Misoprostol-Only Abortions and Are They Safe for the Mother?

Misoprostol is a medication prescribed for ulcer treatment. Several organizations recommend using only misoprostol for a chemical abortion. 

The FDA, however, warns against using the misoprostol-only abortion method.
Studies have shown that this method is less effective. It results in a higher number of ongoing pregnancies. It is also shown to cause more side effects (particularly diarrhea, chills, and fever) than the two-pill regimen. 

More concerning, the drug label for Cytotec (the brand version of misoprostol) warns about the dangers of using the drug while pregnant, even for an abortion. The label warns that:  

• • Pregnant women might suffer uterine ruptures if they take misoprostol to “induce labor or to induce abortion.” Women who have had previous uterine surgeries (including cesarean section) and/or are farther along in their pregnancies have a higher risk of tearing. Ruptures may lead to dangerous bleeding, hysterectomy, and death for both mothers and babies. 
  • Preborn babies may survive first-trimester abortions using misoprostol but develop birth defects, such as cranial nerve palsies, facial malformations, and skull and limb defects, that cause late-term stillbirths. 
  • “Abortions caused by Cytotec may be incomplete,” which can lead to severe bleeding, hospitalization, and surgery. 
  • Abortion advocates support this method, despite its risks, because of misoprostol’s easy access. It’s not as tightly regulated as mifepristone (an abortifacient). But it’s clear that misoprostol abortion recommendations put women at risk and neglect serious safety concerns. 

Is It Safe for the Mother to Take Mifepristone or Misoprostol Vaginally?

Planned Parenthood and other abortion advocates recommend this method. It’s often referenced for a misoprostol-only abortion. But it is not safe to take the abortion pill vaginally.  

Several women died after using this method for the abortion pill. In its 2023 report on mifepristone’s adverse events, the FDA notes, “Nine of the 11 fatal sepsis cases reported vaginal misoprostol use.” 

Abortion Pill Laws and Regulations

What Is the Mifepristone REMS Program? 

When the FDA approves a new drug, it considers the dangers of the medication’s risks. It creates a Risk Evaluation and Mitigation Strategy program for drugs with more serious safety concerns. These guidelines limit both use and access to minimize potential harm. 

Of the 20,000+ drugs that the FDA has approved, only 66 are considered dangerous enough to need an REMS program. Mifepristone is one of those drugs. 

The FDA created an REMS program for the abortion pill because of “the risk of serious complications associated with mifepristone when used for medical termination of pregnancy through ten weeks gestation.

Under the REMS restrictions:  

• • Both healthcare professionals and pharmacies who want to provide mifepristone must be authorized, verified, and certified under the program. 
  • Healthcare professionals must prove that they can safely assess patients (including diagnosing ectopic pregnancy) before prescribing mifepristone. They must also be able to treat patients for complications or have a plan for providing treatment through others. 
  • Patients must review and sign a form that explains the risks before getting the drug from certified pharmacies and prescribers. 
  • Danco Laboratories and GenBioPro, which manufacture the brand name and generic forms of mifepristone, manage this process. Despite the potential conflict of interest, these companies certify and decertify prescribers. 

Under the original REMS rules, a pregnant mother had to go to a clinic to get mifepristone. A doctor had to examine her in person and give her a pregnancy test. This step confirmed she had a typical (not ectopic) pregnancy

If pregnant and still desiring an abortion, she would swallow 600 mg of mifepristone—the first in the pill regimen—in front of the doctor. She would take the second—400 mcg of misoprostol—at the clinic as well. Two weeks later, she would see the physician again for an in-person follow-up visit. The doctor would make sure the abortion was complete

In 2016, the FDA changed the regimen and REMS rules, including: 

• • Lowering the mifepristone dose to 200 mg and raising the misoprostol dose to 800 mcg 
  • Increasing the gestational limit from 49 days (seven weeks) to 70 days (10 weeks) 
  • Letting patients take misoprostol at home 
  • Relaxing the post-abortion exam requirements to allow telehealth assessments within 7-14 days after the abortion 
  • Giving prescribing authority to certified healthcare professionals other than physicians  

During the COVID-19 pandemic, officials suspended the REMS in-person rule. This allowed women to obtain the drugs through telehealth appointments. 

In 2021, the FDA adjusted the REMS requirements to make this change permanent. Since then, a woman has only needed a telehealth exam to get a prescription and pick it up from a certified pharmacy. She can take both pills at home and without medical supervision. 

In 2023, the FDA changed the REMS rules for retail pharmacies. CVS, Walgreens, and other retail pharmacies can now become certified under the REMS program. To become certified, pharmacies must now also have the ability to mail the drugs to patients with prescriptions. 

These regulations are subject to state laws. 

Danco Laboratories v. Alliance for Hippocratic Medicine: Current Legal Challenges to Mifepristone’s Regulations 

In November 2022, a legal group called Alliance Defending Freedom filed a lawsuit against the FDA. They work on behalf of several medical associations and physicians. This suit alleged that the FDA illegally approved mifepristone. It also failed to properly assess its safety. 

On April 7, 2023, Matthew Kacsmaryk, a federal judge in Texas, sided with the ADF. He suspended mifepristone’s approval, a move that would have banned the use and availability of the drug. The judge also agreed that an existing law made “mail-order abortion,” or sending the abortion pill through the mail, illegal. 

In his decision, Kacsmaryk included a seven-day stay on his order. The stay gave the Department of Justice time to file an appeal on behalf of the FDA. The DOJ and Danco Laboratories (which manufactures Mifeprex, the brand version of mifepristone) filed the appeal. They also made emergency requests to the US Supreme Court to put a hold on the order

The Supreme Court called an emergency session and decided to stay Kacsmaryk’s order. Mifepristone would remain legal and available throughout the United States. 

The appeal then took the case to the 5th US Circuit Court of Appeals. This court determined that too much time had passed since the FDA approved mifepristone in 2000 to challenge that decision.  

It also ruled that the FDA ignored proper processes when making changes to the drug’s regulations in 2016 and beyond. The unlawful changes include:  

• Allowing mifepristone to be prescribed by a health professional other than a doctor 
• Sending it through the mail 
• Using it after 49 days of pregnancy 

The appeals court determined that the abortion pill use should follow pre-2016 rules. Its judgment, however, is on hold until the Supreme Court rules on the case or ends its stay. 

The DOJ and Danco Laboratories filed a petition to the Supreme Court after this decision. They asked the court to hear the case and rule on the 5th Circuit Court of Appeals’ judgment. ADF filed a cross-petition. It requested that the court deny the petition and let the ruling stand. 

On December 13, 2023, the Supreme Court announced that it will hear the case. It heard oral arguments for the case on March 26, 2024. 

On June 13, 2024, the Court released its opinion. It unanimously ruled that the plaintiffs lacked standing to sue the FDA. These doctors don’t use or prescribe the abortion pill themselves, the Court said. Instead, they were challenging mifepristone’s regulations on behalf of others.

That means they don’t have the legal right to sue the FDA.

In the opinion, Justice Brett Kavanaugh acknowledged that the plaintiffs have “sincere legal, moral, ideological, and policy objections” to mifepristone’s use. But they don’t have the legal standing to address these concerns through a lawsuit. Instead, he said, they should try to address these concerns by seeking “greater regulatory or legislative restrictions.”

The Supreme Court did not rule on the safety of the abortion pill or the FDA’s regulations in this decision. It only addressed procedural issues with the lawsuit. This opens the door for future cases that challenge both.

For now, mifepristone’s use will continue to follow the most current regulations.

This information is accurate as of June 2024.  

Do Any States Have Laws Regulating the Abortion Pill? 

Since the 2022 Dobbs v. Jackson Women’s Health Organization decision, 14 states have passed a near-total ban on abortion. Women cannot legally have a chemical abortion in these states. 

Additionally, 15 states (Alaska, Arizona, Florida, Georgia, Iowa, Kansas, Michigan, Nebraska, Nevada, North Carolina, Ohio, Pennsylvania, South Carolina, Utah, and Wisconsin) have active legal restrictions on abortion pill use: 

• All these states require physicians to prescribe the drugs 
• Five states (Arizona, Nebraska, North Carolina, South Carolina, and Wisconsin) require in-person appointments to get a prescription as well 
• In Wisconsin, women must take mifepristone in the presence of a doctor during their in-person appointment 
• Arizona also bans mailing the abortion pill 

Six states have abortion pill laws that are currently blocked by court orders: 

• Iowa’s law requiring an in-person appointment with a physician is permanently blocked, though a physician must still provide the prescription 
• Requirements for an in-person appointment to get a prescription and for mothers to take the first dose in the presence of a physician in Kansas are temporarily blocked 
• A Minnesota law that only allows physicians to prescribe the pills is temporarily blocked 
• Montana legislation requiring gestational limits and in-person appointments with a doctor, plus a ban on mailing the drugs, is temporarily blocked 
• In Ohio, requirements for in-person visits with a physician and for taking mifepristone in the presence of a physician are temporarily blocked 
• Wyoming passed a law that would have banned chemical abortions after June 2023, but it is temporarily blocked pending a court case against it 

This information is subject to change and is accurate as of April 2024. 

Can Women Get Mifepristone Online or through the Mail?

A federal law known as the Comstock Act prohibits the mailing of drugs that would be used for illegal abortions. Some argue that includes mailing the abortion pill to states where abortion is illegal. 

But the Department of Justice disagrees. In January 2024, it argued that mifepristone and misoprostol are used for medical reasons other than abortion. Since the drugs could be used legally in states with abortion bans, the Comstock Act doesn’t apply.  

Though it’s illegal in states with abortion bans, some outside sources still mail the abortion pill to residents. The Danco Laboratories v. Alliance for Hippocratic Medicine decision may clarify the legality of mailing the abortion pill to states with bans. 

Certified physicians and pharmacies can mail the abortion pill to patients in most states that allow abortion. The patients must have a prescription for the drugs. It is illegal to get the abortion pill through the mail without one. 

Regardless of the serious safety concerns, a network of abortion activists illegally sells variations of mifepristone and misoprostol online. They mail the abortion pills to customers throughout the US, including those in states that have banned abortion. These activists obtain the drugs from various sources, many based in foreign countries. These illegal abortion pills may not meet safety standards. Taking these pills can increase the mother’s risk of harm.  

Most alarming, anyone can buy the drugs from these websites. They don’t verify the ages of customers or require proof of pregnancy. Only a few require prescriptions. Some sites ask customers to pay through hard-to-track options such as cryptocurrency or Zelle payments. They encourage customers to use VPNs and fake email addresses as well. 

This allows anyone—including young girls, sex traffickers, and abusive partners—to buy the abortion pill easily.  

Many of these websites deny liability for any complications that the women experience. They also instruct customers to hide their abortion pill use and claim they are having a miscarriage if they seek medical help. 

The FDA strongly cautions against ordering mifepristone and misoprostol from online or foreign sources. In fact, it has sent warning letters to websites such as AidAccess and Rablon, telling them to stop selling the abortion pill online. According to the FDA, these websites offer misbranded and unapproved medication.