What everyone should know about misoprostol-only abortions

The abortion industry has made clear its plans to pivot to dispensing misoprostol alone for chemical abortions if challenges to the FDA-approved abortion pill regimen of mifepristone (200mg)/Mifeprex and misoprostol are successful.

In part one of this three part series, Live Action News will give a short primer on misoprostol as it relates to abortion. (Read parts two and three.)

Key Takeaways:

• Though the abortion industry plans to pivot to dispensing misoprostol-only abortions if mifepristone is restricted by the FDA, there are multiple concerns about using the drug alone aside from the intentional killing of preborn children.

• The drug's manufacturer never tested it for use in abortions; in fact, its use as the second drug in the abortion pill regimen is actually off-label. It was originally approved to reduce the risk of stomach ulcers caused by NSAIDs.

• Administered alone for the off-label use of abortion, the drug is estimated to fail at completing the abortion around 15% of the time.

• Unlike mifepristone, misoprostol has been shown to have a teratogenic effect on the developing child, potentially leading to birth defects.

• It is estimated that one in six babies may survive a misoprostol abortion, and they have a higher likelihood of birth defects.

• Misoprostol also carries a risk of uterine rupture during pregnancy.

The Details:

What Is misoprostol?

Misoprostol, a drug originally manufactured by Searle under the brand name Cytotec, is FDA-approved to reduce the risk of stomach ulcers caused by NSAIDs like ibuprofen (Advil, Motrin), as noted by GoodRx.

However, it is also used off-label in the FDA-approved abortion pill regimen alongside mifepristone (200mg). (The two-drug regimen is required because mifepristone alone is significantly less effective.) Misoprostol is contraindicated for pregnancy. It is considered a prostaglandin analog, which is known to induce labor. It causes the cervix to soften and dilate, and to stimulate powerful contractions of the uterine muscle (myometrium). This uterine activity expels the embryo or fetus and pregnancy tissue.

Author Carrie Baker wrote that "The use of prostaglandins for inducing abortion was discovered in the 1960s by Dr. Marc Bydgeman at the Karolinska Institutet in [Sweden]."

Misoprostol was first registered in Brazil in 1986 and was sold in pharmacies and drug stores without a prescription. It was later approved in the United States by the FDA in December of 1988. In 1985, Monsanto purchased G.D. Searle & Company as “a way for Monsanto to bring to market the drugs it is developing in its biotechnology laboratories,” according to a report by the New York Times. As Live Action detailed in its abortion pill report:

Just prior to the FDA’s approval of RU-486, Searle issued a “Dear Health Care Practitioner” letter emphasizing that Cytotec was contraindicated for use in pregnant women and not approved for induction of labor or abortion.

Within a few months, the American College of Obstetricians and Gynecologists (ACOG) a pro-abortion organization, responded with a citizens petition requesting that the FDA Commissioner “take administrative action to require the withdrawal” of Searle’s letter and to “rescind any contraindications for use of misoprostol in pregnancy” on the drug’s label to “conform with the agency’s approval of the mifepristone-misoprostol combination on September 28, 2000….”

Which is exactly what the FDA did.

In 2000, misoprostol was approved by the FDA to be used in the abortion pill regimen, but it is not the abortion pill (mifeprex/mifepristone 200mg)...

Consequently, misoprostol is not subject to the REMS safety system; some irresponsible actors in the abortion industry may recommend it as a one-drug regimen for abortion, even though the FDA has never approved this single-drug usage.

In 1988, New York Times (NYT) spoke to Searle spokeswoman Kay Bruno:

To test the drug's hazards in pregnancy, Ms. Bruno said Searle gave Cytotec to a small group of women in their first trimester of pregnancy who planned on having abortions. The tests, conducted in West Germany in the early 1980's, showed that the drug caused ''uterine expulsion and bleeding,'' Ms. Bruno said.

But she said the study was too small to indicate the likelihood that the drug would cause an abortion. In addition, she said, the drug was not tested at different doses, so there is no information on the dose required for an abortion.

In 2000, Searle spokesperson Claudia Kovitz told NYT that Searle "did not test misoprostol for abortions and will not be promoting its use in abortions. Kovitz pointed out, in fact, the drug carries a black boxed warning saying it is not to be used in pregnancy" (emphases added).

GenBioPro (GBP), approved in 2019 by the Trump administration as the first generic abortion pill maker, also manufacturers a generic misoprostol, 200 mcg. The drug has a strict storage temperature requirement, raising concern over stability of the drug when shipped in extreme temperatures by mail.

National Abortion Federation on misoprostol-only

"Where legally available and accessible, mifepristone and misoprostol should be used," recommends the National Abortion Federation (NAF) in its 2026 Clinical Guide under "Medication Abortion Before 14 Weeks LMP."

For the two-drug regimen, NAF recommends:

• An additional dose of misoprostol 800mcg... for patients over 63 days LMP.

• More than two doses of misoprostol may be provided for patients as gestational duration increases or if a patient is remote from care.

NAF only recommends misoprostol-only "[w]here mifepristone is either not legally available or inaccessible," but advises that "The efficacy of these regimens for pregnancy of unknown location and pregnancies from 12-14 weeks LMP is not well studied. People who use these regimens need to understand their efficacy, side effects, and the potential exposure to known teratogens if the pregnancy continues."

NAF adds:

"Patients must be offered a follow-up assessment to confirm absence of ongoing pregnancy. Confirmation can be established by ultrasonography, hCG testing, physical exam, or self-assessment."

"Mifepristone increases the efficacy and decreases the total time and doses needed for misoprostol to cause pregnancy expulsion," NAF claims of later chemical abortions.

Efficacy of misoprostol

Planned Parenthood's website claims a misoprostol-only abortion is "safe [and] effective," yet cites zero studies to show this.

The abortion corporation then claimed the one-drug regimen works 85-95% of the time, indicating it would fail from 5-15% of the time.

Using the 732,000 estimated abortion pill abortions nationally, this could translate to between 36.6K to 109.8K women annually having an incomplete abortion.

Planned Parenthood claims misoprostol "can be used up to 12 weeks from the first day of your last period," suggesting use later in pregnancy may be problematic.

Under the telehealth mail-order system, rarely are women examined to

• verify pregnancy.

• validate gestational age.

• rule out potentially deadly ectopic pregnancies, which cannot be treated using mifepristone or misoprostol.

Dr. Ingrid Skop, a pro-life OBGYN with ties to the Charlotte Lozier Institute (CLI), has expressed concerns.

"Systematic reviews document between 15-22% of early misoprostol-only abortions fail to expel all the pregnancy tissue, necessitating surgical completion, often in emergencies," Skop told Live Action News.

Dr. Skop published research on misoprostol at CLI, citing studies addressing misoprostol failures:

• A 2010 study documented that misoprostol alone led to a 23.8% failure rate requiring surgery...The embryo or fetus continued to survive in 16.6% of the pregnancies. In contrast, there were 3.5% failures and 1.5% continuing pregnancies in the mifepristone and misoprostol comparison group.

• Likewise, a 2013 study demonstrated 38.8% failures when misoprostol was used vaginally and 29.8% when used sublingually (under the tongue).

• Similarly, a 2000 randomized trial documented that 35% of women using unmoistened vaginal misoprostol had failures requiring surgery.

• A 2019 systematic review...found 22% required surgical completion and 6.8% had ongoing living pregnancies...

• A 2023 updated systematic review by the same authors...documented only slightly improved data, with treatment failures in 15% and ongoing pregnancies in 6% of the over 9,000 women for whom this outcome was reported.

Other concerns:

Birth defects

"There is no evidence that mifepristone exposure has a teratogenic effect on an ongoing pregnancy," wrote NAF. But this isn't the case for misoprostol.

"Misoprostol exposure early in pregnancy doubles the risk of causing major fetal malformations in a continuing pregnancy, from approximately 2% in cases with no exposure to 4% in cases of misoprostol exposure," NAF stated.

"For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication," Daily Med states, adding under the headline SPECIAL NOTE FOR WOMEN: "Misoprostol Tablets may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women."

Writing at CLI, Dr. Skop adds:

Misoprostol is known to produce birth defects... Continuing living pregnancies occur 6-16% of the time when these drugs are taken, so if the drug exposure occurs during the critical period in the first trimester when the baby’s organs are forming, and if a woman subsequently gives birth, there is potential the child will suffer from devastating congenital anomalies.

Live birth potential

Dr. Skop claimed that "Nearly one in six babies continued to live, but misoprostol exposure places these surviving children at risk for potentially severe birth defects."

She added:

Misoprostol is commonly used to induce labor, so if it is used later in pregnancy in attempts to cause an abortion, living babies may deliver prematurely, potentially dying if medical care is not sought at that time. In women with one or more prior c-sections, the strong contractions induced by misoprostol can even cause uterine rupture, a potentially fatal complication for a mother.

Complications and death

Daily Med wrote under "patient information":

Misoprostol tablets may cause the uterus to tear (uterine rupture) during pregnancy. The risk of uterine rupture increases as your pregnancy advances and if you have had surgery on the uterus, such as a Cesarean delivery. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

This is reiterated on the drug's label.

Live Action News previously documented the death of  a 16-year-old girl in Papua New Guinea (PNG) who died after purchasing misoprostol on the street, later taking it to abort her pregnancy. 

The Bottom Line:

"These frequent and devastating complications demonstrate this regimen is 'unsafe and ineffective,' especially when used without medical oversight, as abortion advocates are increasingly recommending," Dr. Skop told Live Action News.

For these reasons and more, any promotion of, or failure to warn against, misoprostol only abortions should be recognized as callous attempts to prioritize ending unborn life over the health and safety of women.

These actions are unacceptable when performed by those who profess to care for women.

Go Deeper:

• The State of Chemical Abortion a Mechanism of Death

• BAD ACTORS: Abortion industry set to promote failure-prone abortion drug if abortion pill goes away

• Induced Abortion with Misoprostol Alone, Dr. Ingrid Skop