Despite growing use, abortion pill not ‘safer than Tylenol’

More than 20 years ago, Toni McFadden took the abortion pill to end her pregnancy. She was a high school senior, the “good girl” in her family, and she did not want anyone to find out.

She was about seven weeks pregnant when she took the regimen’s first drug — mifepristone — at an abortion clinic. She was sent home to take the second drug — misoprostol — at home. The doctor told her to expect bleeding like a heavy period. When she took the misoprostol, nothing happened. She called the clinic, and was briskly instructed to take a back-up dose she had been given. She did, and there was just a little spotting — but, since she was told the baby was only the “size of a pea,” she thought maybe that was it.

A month-and-a-half later, she was sitting in class when she started to feel “excruciating” pain and began passing blood clots the size of her fist. She realized what was happening, but was unprepared for the pain intensity or blood loss. She called her mother, told her she was experiencing bad menstrual cramping, and went home to sit on the toilet and lay on her bed. She does not remember how long she bled, or if she saw her baby as she passed it in the toilet. “There’s a lot of trauma with that,” she explained. She does remember laying curled up, in the fetal position.

McFadden, now 43, has become a Christian and pro-life activist. A Pennsylvania native, she continues to share her story amid a national conversation about the availability of “chemical” or “medication” abortion, as well as the protocol some doctors use to interrupt the first pill’s effect, which can save the unborn baby.

“I think people think, ‘Oh it’s just a pill, it’s really easy,'” McFadden told OSV News May 9. “No, there’s something different with this procedure, because with the other procedures, in the second and third trimester, the doctors are doing that to you. With the pill, I took it. Like, I put these pills in my mouth. So, when I had to come to the reality that I took the life of my own child, that hits a little bit different than me being sedated, laying on a table and the doctor took my child.”

In the two decades since McFadden’s abortion, the abortion pill regimen has remained largely the same — a dose of the drug mifepristone followed by misoprostol 24 to 48 hours later — but protocols around it have loosened dramatically, from initially taking place at a clinic under a doctor’s care, to being available by mail after a virtual doctor visit or filling out a form.

Chemical abortion — the term favored by pro-life advocates because they say “medication abortion” connotes health — now accounts for 54 percent of U.S. abortions in 2022, up from 39 percent in 2017, according to the Guttmacher Institute, a research organization with historical ties to Planned Parenthood, the nation’s largest abortion provider. The U.S. Food and Drug Administration estimates 5.6 million women in the United States used mifepristone for abortion between September 2000 and June 2022.

Despite its growing use, the abortion pill’s safety has been repeatedly called into question by pro-life doctors and advocates since the FDA’s approval in 2000 of mifepristone. On May 17, a U.S. appeals court considered a lawsuit filed in Texas against the FDA, alleging that the agency unnecessarily accelerated mifepristone’s initial approval in 2000 without following usual protocols, and that the FDA also incrementally removed safeguards for the regimen’s use without sufficient evidence to support the deregulation.

While abortion advocates have praised the lowering of restrictions around the drug in the name of access, pro-life advocates say that has come at the expense of women taking the drug. “The health and safety of women has just been thrown out the door to allow for online, no test distribution,” said Kristi Hamrick, chief media and policy strategist for Students for Life of America, which runs the website thisischemicalabortion.com and has fought against expanding the abortion pill’s distribution on college campuses.

Mifepristone — also known as RU-486 or under the brand Mifeprex — works by blocking the hormone progesterone, which the preborn child needs to live. Misoprostol, also known under the brand name Cytotec, induces contractions to expel the aborted baby.

For the first two decades following mifepristone’s FDA approval, prescriptions for the abortion pill required the first drug to be administered at a medical clinic. Medical professionals needed to confirm the pregnancy and determine that the pregnancy was not ectopic — where the fertilized egg grows outside of the uterus, and, if undetected, is deadly to the mother — or that the baby’s gestational age had not exceeded the drug’s approved timeframe.

When the FDA first approved Mifeprex, it was authorized for the first seven weeks of pregnancy. In 2016, the FDA expanded its use to the first 10 weeks of pregnancy. Studies show that the risk for complications increases the further along the pregnancy is.

In 2021, the FDA announced it was permanently allowing the abortion pill to be obtained by mail, rather than through an in-person visit to a clinic — a requirement it first lifted temporarily during the COVID-19 pandemic. In January, the FDA changed regulations to allow drugstores to fill prescriptions for mifepristone. The changes have made it possible for women to obtain a prescription for the abortion pill without having been physically evaluated to determine how old the baby is, screened for risk factors, or evaluated for signs of trafficking, abuse or coercion.

Last year’s U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization returned abortion policy to state lawmakers, creating a patchwork of abortion laws across the country. Between April and December 2022, abortion pills obtained through telehealth visits with virtual-only clinics increased by 136% — from 3,610 to 8,540, increasing each month — according to an April 2023 report from the Society of Family Planning, an organization which studies abortion trends.

Abortion activists view telehealth as a means to get the abortion pill to women in states where abortion is restricted or outlawed, or where contested laws made its future legality uncertain.

In her role as Project Rachel coordinator in the Diocese of Toledo, Ohio, Kerstin Pakka regularly speaks with women seeking healing from abortion. In the past year, she said she has been contacted by an increasing number of women who have had chemical abortions, and they often are looking for help weeks after the abortion, much sooner than the years that pass for many women who have had surgical abortions before they seek out Project Rachel.

Chemical abortion is a “completely different trauma, it’s a completely different experience” from surgical abortion, Pakka said.

“With a chemical abortion at home, you are there usually by yourself and you’re experiencing everything. You’re the one taking the pills, you are the one experiencing the symptoms, and you’re the one who was seeing what happened,” she said. “It’s a very immediate sense of ‘this isn’t just a clump of cells. This isn’t just tissue. This is my child.'”

The abortion pill is prescribed for as late as 12 weeks gestation. By nine weeks, the embryo has visible characteristics — limbs, hands, a face with discernible eyes, nose and ears. Most women who have chemical abortions presumably flush their baby’s body down the toilet, which has been the case for the women Pakka has counseled.

“It definitely adds to the trauma then, that that’s the way they have to dispose of their baby,” she said. For some women she knows, being at home, or in the bathroom or shower, triggers post-abortion trauma.

In November, the pro-life organization Alliance for Hippocratic Medicine filed a lawsuit in Texas alleging that the FDA caved to political pressure and violated its own safety standards by fast-tracking its 2000 approval of mifepristone, and it has not sufficiently studied complications associated with mifepristone to support its initial approval or subsequent reduction of safety protocols. The complaint also alleged that the FDA was in violation of the Comstock Act, which prohibits the mailing of abortion drugs.

In April 7, a U.S. district judge in Amarillo ruled in favor of the plaintiffs and issued a stay on mifepristone, effectively suspending the FDA’s approval of the drug. Shortly after, a U.S. district judge in Washington state filed a conflicting ruling aiming to block the FDA from “altering the status quo” for mifepristone. A week later, a three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans ruled to temporarily block the drug’s total suspension, but restored the restrictions present with the drug’s initial approval in 2000. On April 21, the U.S. Supreme Court granted a request from the Justice Department and Danco Laboratories, whose sole product is Mifeprex, to block the stay, allowing mifepristone’s current use as the case moves through the 5th Circuit. The court heard arguments in the case May 17.

Charlotte Lozier Institute, the research arm of the pro-life organization SBA Pro-Life America, filed an amicus brief in the Texas lawsuit. Dr. Ingrid Skop, its vice president and director of medical affairs, calls foul on some abortion-supporter’s claims that the abortion pill is safer than Tylenol.

“It’s a dishonest comparison,” she said. “They look at the number of Americans who die of Tylenol overdoses, which is about 600 a year, and they compare it to the vastly undercounted deaths that are attributed to abortion,” about two a year, she said. “That comparison fools women into thinking, ‘Oh, I take Tylenol for a headache and it’s never hurt me. So this chemical abortion must be a similar process,’ but it’s not.”

One survey found 40% of women described the pain as “severe,” said Skop, a board-certified obstetrician-gynecologist who has retired from private practice but still covers labor and delivery and emergency care at a Texas hospital several times a month.

Even with a doctor’s oversight, it is not safer than surgical abortion, Skop said. From the available data, “It looks like it’s probably about one in 20 women that will have an emergency room visit, and about one in 20 women that will require surgery,” she said.

Experts have interpreted available data differently, with some determining that chemical abortion is relatively safe, and others determining it is not. Skop said that because the FDA does not mandate health care providers to report non-death complications, the data is incomplete, and the studies the FDA cites were done by organizations that describe themselves as committed to readily available abortion.

Skop helped to author a study published in 2021 of post-abortion emergency room use in 17 states from 1999 to 2015. It concluded that “chemical abortion is consistently and progressively associated with more postabortion ER visit morbidity than surgical abortion,” and that “There is also a distinct trend of a growing number of women miscoded as receiving treatment for spontaneous abortion in the ER following a chemical abortion.”

Women who take the abortion pill are unlikely to know when typical bleeding or pain becomes a health emergency, or if they are actually experiencing life-threatening complications from ectopic pregnancy, Skop said. That knowingly puts a burden on emergency room care, she said.

The FDA states that as of June 2022, there had been 28 reports of death associated with, but not necessarily caused by, mifepristone, since its September 2000 approval. Other associated complications include hospitalization, blood loss requiring transfusion and infections. The drug carries a “black box warning” — the FDA’s strongest warning for drugs with major risks — and a Risk Evaluation and Mitigation Strategy, or REMS, which the FDA describes as “a drug safety program … for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”

However, Plan C, a website Planned Parenthood supplies as a resource to help women obtain the abortion pill by mail, calls them “very safe” and focuses on potential legal risks over health risks when advising women how to obtain the abortion pill. The Plan C website includes scenarios where women have “gotten in legal trouble” for going to urgent care, where “my doctor reported me to the police,” or cases where trusted family or friends “reported” them. It also says people can buy pills now to use later, “just in case,” a practice pro-life advocates say is rife with potential abuse by traffickers and abusers. The drugs reportedly cost from $40 to $600 or more.

As some states have expanded the availability of the abortion pill, they have also sought to eliminate the availability of abortion pill reversal, where mifepristone’s effects are reversed prior to the dose of misoprostol through a strong dose of progesterone. The practice is controversial, but doctors who use it say it has helped women save their babies. A Colorado ban on the treatment is moving through the courts.

Skop said she is grateful for the media attention drawn to the Alliance for Hippocratic Medicine’s lawsuit, because it raises awareness about chemical abortion and provides an opportunity to draw attention to its widespread use and risks, and dispels misunderstandings, such as that it’s the same as Plan B — also known as the morning-after pill or “emergency contraception” — an abortion-inducing drug taken within days of having sex, not weeks into a pregnancy.

And while she hopes that the lawsuit will lead to FDA oversight, force the agency to further study mifepristone, reinstate the drug’s initial 2000 regulations and institute a federal mandate for abortion reporting, she said she’s not advocating for mifepristone to be taken off the market entirely. If that happens, she is concerned that chemical abortion providers will turn to misoprostol-only methods, which induce labor without first killing the baby.

“No. 1 is to really get people thinking about what is abortion,” Skop said. “Does it help women, and if a woman is going to have an abortion, should we give her one that’s more dangerous, as opposed to a surgical abortion?”

She is also not surprised that more women don’t speak out about a negative chemical abortion experience. She has asked women who experience complications if they want to file a complaint, only to be told they feel they deserve what happened. “They just want to put it away in the back of their mind, and they want to move on,” she said. “But it is a horrible experience, and we really need to try to keep women from having to go down that road.”

As chemical abortion continues to climb as a proportion of overall U.S. abortions, the differences between the experience of chemical and surgical abortion impacts how post-abortive healing ministries such as Project Rachel minister to them, said Pakka, the Project Rachel coordinator in Toledo.

Women who have taken the abortion pill “feel that they are solely responsible for what happened,” she said. “My job is to show them that they are loveable, that they are loved, that they are worthy of forgiveness of mercy, and that they’re not alone.”

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