Table of ContentsView AllTable of ContentsIs Using Misoprostol Alone Safe and Effective for a Medication Abortion?How Will Banning Mifepristone Affect Abortion Access?What Happens If the Abortion Pill Is Really Banned?

Table of ContentsView All

View All

Table of Contents

Is Using Misoprostol Alone Safe and Effective for a Medication Abortion?

How Will Banning Mifepristone Affect Abortion Access?

What Happens If the Abortion Pill Is Really Banned?

Key TakeawaysA federal court in Texas issued a preliminary ruling calling for the FDA to suspend or restrict its approval of a key abortion drug, mifepristone.Mifepristone is one of two drugs that comprise the most common method of medication abortion.Misoprostol, the second drug, is considered safe and effective when used alone in off-label abortion care.

Key Takeaways

A federal court in Texas issued a preliminary ruling calling for the FDA to suspend or restrict its approval of a key abortion drug, mifepristone.Mifepristone is one of two drugs that comprise the most common method of medication abortion.Misoprostol, the second drug, is considered safe and effective when used alone in off-label abortion care.

A federal judge in Texas issued a preliminary ruling to end access to the abortion drug mifepristone, including in states where abortion is legal.

U.S. District Judge Matthew Kacsmaryk is allowing for seven days to pass beforehis rulingtakes effect. This means the Supreme Court or an appeals court has the opportunity to appeal the decision.

A coalition of anti-abortion groups initiated the case last month, asking Judge Kacsmarykto force the Food and Drug Administration (FDA) to withdraw its approval of mifepristone.

“This will mean that the most common way of providing abortions in this country, with over two decades of rigorous scientific testing providing evidence of its safety, will no longer be accessible to people throughout this country, including in states that have overwhelmingly supported abortion access such as New York, California, Massachusetts, and Illinois,” saidLeah Coplon, CNM, MPH,a nurse-midwife and Director of Clinical Operations at Abortion on Demand.

But even without mifepristone, a few doses of misoprostol alone is safe and nearly as effective as the two-drug regimen. The FDA hasn’t approved a misoprostol-only abortion regimen,but major medical organizations say providers can prescribe it off-label for inducing abortion up to 10 weeks of pregnancy. The risk of adverse events is less than 2%.

A February study, the first to look at the use of misoprostol for abortions in the U.S., found the misoprostol-only method to be 88% effective without intervention.Studies from other countries have reported efficacy rates as high as 99%and the World Health Organizationcites itas a good alternative when mifepristone is unavailable.

In the standard medication abortion, mifepristone prepares the cervix for misoprostol. Without that first step, the process can take as long as five days to complete, said Caitlin Blau, DO, a family physician and abortion care expert at Blue Mountain Clinic in Missoula, Montana.

“It may include a little bit more physical discomfort, and requires monitoring and follow-up to make sure that the process is complete, which is true of the standard regimen as well,” Blau told Verywell. “Why would we want a patient to have cramping and bleeding for several days and be uncomfortable when there’s a better alternative?”

The efficacy of misoprostol varies depending on the dosage and the way its administered. The American College of Obstetricians and Gynecologists recommends giving at least three doses three hours apart until the pregnancy has passed.

Sometimes, though, it takes more than three doses for the regimen to be effective, Blau said. In that case, it’s important that patients can access additional pills. She said it’s fairly easy to fill misoprostol prescriptions in most U.S. pharmacies.

Planned Parenthood already offers its patients the option to take misoprostol alone, according toBhavik Kumar, MD, MPH, a family physician and Medical Director for Primary and Trans Care at Planned Parenthood Gulf Coast.

Despite the effectiveness of a misoprostol-only regimen, reproductive rights advocates say a ruling that disrupts access to mifepristone narrows options for patients at a time when abortion is restricted or totally banned in many states.

“Without the use of mifepristone, it takes away a great option for patients to be able to choose,” Kumar told Verywell. “[My patients] would get to decide what their priorities are what’s best for them and what makes sense for them. And so not having this option is a real loss for many patients.”

Lawyers from the Justice Department, representing the FDA and a company that makes mifepristone, cited decades of scientific research on the safety and efficacy of the drug, theNew York Timesreported. The lawyers also noted mifepristone has been regulated more closely than most other drugs under the FDA’sRisk Evaluation and Mitigation Strategy (REMS)safety plan.

According to theAmerican Medical Association, mifepristone is one of the best-studied medications in the U.S. There have been more than 630 clinical trials, including 420 randomized controlled studies, involving mifepristone.

Serious adverse events—blood transfusion, hospital admission, or infection—occurin about 0.5% of medication abortions.

“This means medication abortion with mifepristone and misoprostol has a better safety profile than other commonly used medications like Tylenol or Viagra,” said Lauren Ralph, PhD, MPH, associate professor in the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

Judge Kacsmaryk’s decision marks the first time a court has ordered the government to withdraw or suspend approval of a longstanding medication against objections from the FDA and the drug’s manufacturer. The move could also have far-reaching implications for the approval and regulatory process for drugs.

With increased restrictions on medication abortion, Kumar said he expects more patients to travel out of state to seek surgical procedures in states where abortion is still legal. That could swamp clinics, forcing people to wait longer to get care.

Restricted access and further anti-abortion litigation could dissuade people from pursuing abortion care when they need it, he said.

“The reality is banning abortion never stops the need for abortion,” Kumar said at a press briefing. “As a physician, it is my ethical duty to ensure that care is safe, patient-centered, and accessible. Attacks like this on a critical and safe medication make my job and that of other compassionate healthcare providers much more difficult.”

If the Texas court decision remains in place and mifepristone loses FDA approval, people may be able to continue accessing the two-drug combination from organizations likeAid Access, which ships the drugs from a pharmacy in India.

For now, patients can still access the standard medication abortion regimen through their health providers andmail-order telehealthcompanies in states where abortion is legal.

“The most important thing to know is that we as your local abortion providers and abortion clinics are here for you,” Blau said. “We’re fighting for you and we’re ready to care for you.”

What This Means For You

3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Johnson DM, Michels-Gualtieri M, Gomperts R, Aiken ARA.Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States.Perspect Sex Reprod Health. Published online February 6, 2023. doi:10.1363/psrh.12219Moseson H, Jayaweera R, Egwuatu I, et al.Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.Lancet Glob Health. 2022;10(1):e105-e113. doi:10.1016/S2214-109X(21)00461-7The American College of Obstetricians and Gynecologists.Medication Abortion Up to 70 Days of Gestation.

3 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Johnson DM, Michels-Gualtieri M, Gomperts R, Aiken ARA.Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States.Perspect Sex Reprod Health. Published online February 6, 2023. doi:10.1363/psrh.12219Moseson H, Jayaweera R, Egwuatu I, et al.Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.Lancet Glob Health. 2022;10(1):e105-e113. doi:10.1016/S2214-109X(21)00461-7The American College of Obstetricians and Gynecologists.Medication Abortion Up to 70 Days of Gestation.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Johnson DM, Michels-Gualtieri M, Gomperts R, Aiken ARA.Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States.Perspect Sex Reprod Health. Published online February 6, 2023. doi:10.1363/psrh.12219Moseson H, Jayaweera R, Egwuatu I, et al.Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.Lancet Glob Health. 2022;10(1):e105-e113. doi:10.1016/S2214-109X(21)00461-7The American College of Obstetricians and Gynecologists.Medication Abortion Up to 70 Days of Gestation.

Johnson DM, Michels-Gualtieri M, Gomperts R, Aiken ARA.Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States.Perspect Sex Reprod Health. Published online February 6, 2023. doi:10.1363/psrh.12219

Moseson H, Jayaweera R, Egwuatu I, et al.Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.Lancet Glob Health. 2022;10(1):e105-e113. doi:10.1016/S2214-109X(21)00461-7

The American College of Obstetricians and Gynecologists.Medication Abortion Up to 70 Days of Gestation.

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