Latest news with #Mifeprex
Yahoo
05-05-2025
- Health
- Yahoo
'Flawed' paper overstates health risks of abortion pills: experts
"The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experience a Serious Adverse Event," says the title of a paper published April 28, 2025 by the Ethics & Public Policy Center (EPPC), a think tank that says its priorities include "pushing back against the extreme progressive agenda while building a consensus for conservatives." The findings quickly spread across platforms and were held up by conservative media, including Fox News. Politicians further amplified the claim. Republican Senator Steve Daines of Montana said in a statement: "This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women's health." Since the US Supreme Court overturned the federal protection of the right to an abortion in 2022, Texas, Louisiana and other conservative states have adopted tough anti-abortion laws. The court ruled in 2024 that defendants in a case that could have restricted access to mifepristone lacked standing, but the medication remains at the center of efforts to limit abortion (archived here and here). The EPPC report came days after US Food and Drug Administration (FDA) Commissioner Marty Makary told PBS that while he was not planning to take action on mifepristone, he was looking at new data and would act if it "suggests something or tells us that there's a real signal" (archived here). But medical abortion has a proven safety record, the ACOG and independent reproductive health experts told AFP. "Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective," said Stella Dantas, president of ACOG (archived here). In an April 30 email, she said the EPPC paper is "seriously flawed" and "manipulates data to drive a myth that medication abortion isn't safe." Mifepristone, which prevents pregnancy progression, and misoprostol, which empties the uterus, are approved to terminate a pregnancy up to 70 days of gestation in the United States. In 2023, they accounted for 63 percent of US abortions. The FDA says on its website that Mifeprex, the brand name for mifepristone, was first approved in 2000 after a review of the scientific evidence "determined that it was safe and effective for its indicated use" (archived here). The FDA monitors postmarketing data for Mifeprex and its approved generic equivalent, and as of February 2025, it has not identified new safety concerns. Jack Resneck, former president of the American Medical Association, wrote in a 2024 message supporting access to the medication that mifepristone is "an exceedingly safe and effective prescription drug" (archived here). Mifeprex maker Danco says on its website that patients will experience cramping and bleeding as part of ending a pregnancy, and as with any prescription drug, there can be rare serious side effects (archived here). The FDA investigated reports of 36 patient deaths that followed taking mifepristone between September 2000 and December 2024. However, its review of these deaths found: "The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient" (archived here and here). Jennifer Lincoln, a board-certified obstetrics and gynecology physician in Oregon, said postmarketing studies show "thousands of people have used mifepristone in conjunction with misoprostol to have abortions that are without complication 99.7 percent of the time" (archived here and here). "It is safer to take than Tylenol and far safer than a full-term pregnancy and birth," Lincoln said, referencing the over-the-counter pain medication, which can lead to liver damage if the recommended dosage is ignored (archived here). The EPPC paper is neither peer-reviewed nor published in a medical journal. It was written by the organization's president of public policy and director of data analysis. The paper's authors say they purchased insurance claim data from 2017 to 2023. From that information, they claim to have identified 865,726 mifepristone abortions by looking for specific procedure, diagnosis and billing codes or prescriptions. Lincoln pointed to flaws with this strategy, including that it counted "people who got mifepristone and may have taken that alone, without misoprostol -- which is not the evidence-based regimen." ACOG's Dantas said the methodology could be overestimating the number of people seeking abortion care by including patients who were prescribed mifepristone to deal with complications associated with miscarriages. Asked about the sample, Hunter Estes, the EPPC's director of communications, dismissed concerns that treatments for a miscarriage would have shown up in the database. "We would not count that as an abortion, even if she was given mifepristone on that visit," he said in a May 2 email. After selecting the patients to track, the paper then looked for medical codes for what it categorized as "serious adverse events that occurred within 45 days following the abortion." Lincoln took issue with the authors including ectopic pregnancy -- a condition where the fertilized egg implants and grows outside of the uterus -- among the negative outcomes. "Pills can't move your pregnancy out of your uterus and into your fallopian tubes," she said. Lauren Ralph, associate professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, agreed (archived here). "Ectopic pregnancy is not caused by a medication abortion, but rather is something that occurs in pregnancy. Abortion medications do not create harm if taken by someone with an ectopic pregnancy," she said in a May 2 email. The paper also recorded 40,960 visits to a hospital emergency department as serious adverse events following medical abortion. EPPC's Estes said the report included only visits deemed "likely to be related to the abortion, based on the diagnosis and procedure codes in the insurance records." But Ralph told AFP a visit to the emergency room alone is not evidence of a serious adverse event. "Prior research indicates that many people go to the emergency department for follow-up care post-abortion, but this care is often to ensure abortion completion or get reassurance about symptoms rather than for treatment of an adverse event," she said, referencing a 2018 study (archived here). She said research has consistently found that the rate of serious adverse events is 0.3 to 0.5 percent -- far lower than the figures pushed by EPPC. When medical abortion was first approved by the FDA in 2000, patients were required to visit a clinic in person to receive the pills (archived here). In December 2021, the policy was updated to allow certain providers to prescribe the medication via telehealth appointments (archived here). Further policy changes allowed pharmacies to be certified to dispense mifepristone directly to patients, and in March 2024, major US chains CVS and Walgreens announced plans to fill prescriptions in Massachusetts and other states where the medication is legal. The EPPC called on the FDA to "reinstate its earlier, stronger patient safety protocols." But a peer-reviewed study published in Nature Medicine in February 2024 found: "Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care" (archived here). Read more of AFP's reporting on misinformation about abortion here.
AFP
05-05-2025
- Health
- AFP
'Flawed' paper overstates health risks of abortion pills: experts
"The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experience a Serious Adverse Event," says the title of a paper published April 28, 2025 by the Ethics & Public Policy Center (EPPC), a think tank that says its priorities include "pushing back against the extreme progressive agenda while building a consensus for conservatives." Image Screenshot of the Ethics & Public Policy Center website taken April 30, 2025 The findings quickly spread across platforms and were held up by conservative media, including Fox News. Politicians further amplified the claim. Republican Senator Steve Daines of Montana said in a statement: "This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women's health." Since the US Supreme Court overturned the federal protection of the right to an abortion in 2022, Texas, Louisiana and other conservative states have adopted tough anti-abortion laws. The court ruled in 2024 that defendants in a case that could have restricted access to mifepristone lacked standing, but the medication remains at the center of efforts to limit abortion (archived here and here). The EPPC report came days after US Food and Drug Administration (FDA) Commissioner Marty Makary told PBS that while he was not planning to take action on mifepristone, he was looking at new data and would act if it "suggests something or tells us that there's a real signal" (archived here). But medical abortion has a proven safety record, the ACOG and independent reproductive health experts told AFP. "Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective," said Stella Dantas, president of ACOG (archived here). In an April 30 email, she said the EPPC paper is "seriously flawed" and "manipulates data to drive a myth that medication abortion isn't safe." Medication abortion Mifepristone, which prevents pregnancy progression, and misoprostol, which empties the uterus, are approved to terminate a pregnancy up to 70 days of gestation in the United States. In 2023, they accounted for 63 percent of US abortions. The FDA says on its website that Mifeprex, the brand name for mifepristone, was first approved in 2000 after a review of the scientific evidence "determined that it was safe and effective for its indicated use" (archived here). The FDA monitors postmarketing data for Mifeprex and its approved generic equivalent, and as of February 2025, it has not identified new safety concerns. Jack Resneck, former president of the American Medical Association, wrote in a 2024 message supporting access to the medication that mifepristone is "an exceedingly safe and effective prescription drug" (archived here). Mifeprex maker Danco says on its website that patients will experience cramping and bleeding as part of ending a pregnancy, and as with any prescription drug, there can be rare serious side effects (archived here). The FDA investigated reports of 36 patient deaths that followed taking mifepristone between September 2000 and December 2024. However, its review of these deaths found: "The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient" (archived here and here). Jennifer Lincoln, a board-certified obstetrics and gynecology physician in Oregon, said postmarketing studies show "thousands of people have used mifepristone in conjunction with misoprostol to have abortions that are without complication 99.7 percent of the time" (archived here and here). "It is safer to take than Tylenol and far safer than a full-term pregnancy and birth," Lincoln said, referencing the over-the-counter pain medication, which can lead to liver damage if the recommended dosage is ignored (archived here). Methodology flaws The EPPC paper is neither peer-reviewed nor published in a medical journal. It was written by the organization's president of public policy and director of data analysis. The paper's authors say they purchased insurance claim data from 2017 to 2023. From that information, they claim to have identified 865,726 mifepristone abortions by looking for specific procedure, diagnosis and billing codes or prescriptions. Lincoln pointed to flaws with this strategy, including that it counted "people who got mifepristone and may have taken that alone, without misoprostol -- which is not the evidence-based regimen." ACOG's Dantas said the methodology could be overestimating the number of people seeking abortion care by including patients who were prescribed mifepristone to deal with complications associated with miscarriages. Asked about the sample, Hunter Estes, the EPPC's director of communications, dismissed concerns that treatments for a miscarriage would have shown up in the database. "We would not count that as an abortion, even if she was given mifepristone on that visit," he said in a May 2 email. After selecting the patients to track, the paper then looked for medical codes for what it categorized as "serious adverse events that occurred within 45 days following the abortion." Lincoln took issue with the authors including ectopic pregnancy -- a condition where the fertilized egg implants and grows outside of the uterus -- among the negative outcomes. "Pills can't move your pregnancy out of your uterus and into your fallopian tubes," she said. Lauren Ralph, associate professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, agreed (archived here). "Ectopic pregnancy is not caused by a medication abortion, but rather is something that occurs in pregnancy. Abortion medications do not create harm if taken by someone with an ectopic pregnancy," she said in a May 2 email. The paper also recorded 40,960 visits to a hospital emergency department as serious adverse events following medical abortion. EPPC's Estes said the report included only visits deemed "likely to be related to the abortion, based on the diagnosis and procedure codes in the insurance records." But Ralph told AFP a visit to the emergency room alone is not evidence of a serious adverse event. "Prior research indicates that many people go to the emergency department for follow-up care post-abortion, but this care is often to ensure abortion completion or get reassurance about symptoms rather than for treatment of an adverse event," she said, referencing a 2018 study (archived here). She said research has consistently found that the rate of serious adverse events is 0.3 to 0.5 percent -- far lower than the figures pushed by EPPC. When medical abortion was first approved by the FDA in 2000, patients were required to visit a clinic in person to receive the pills (archived here). In December 2021, the policy was updated to allow certain providers to prescribe the medication via telehealth appointments (archived here). Further policy changes allowed pharmacies to be certified to dispense mifepristone directly to patients, and in March 2024, major US chains CVS and Walgreens announced plans to fill prescriptions in Massachusetts and other states where the medication is legal. The EPPC called on the FDA to "reinstate its earlier, stronger patient safety protocols." But a peer-reviewed study published in Nature Medicine in February 2024 found: "Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care" (archived here). Read more of AFP's reporting on misinformation about abortion here.
Newsweek
02-05-2025
- Health
- Newsweek
New Research Shows Abortion Pills' Real Risk
Taking abortion pills is "safer than taking Tylenol." So claimed ANSIRH, an abortion advocacy and research organization based at University of California San Francisco, in an X post on April 14. "Anti-abortion misinformation has exploded since the end of [Roe v. Wade]," the group wrote. "Anti-abortion activists want you to believe that abortion pills are dangerous, but in reality, they're safer than taking Tylenol." But a report on new data released this week by my colleagues Ryan Anderson and Jamie Bryan Hall at the Ethics and Public Policy Center proves otherwise. Their analysis of insurance data from an all-payer insurance claims database indicates that more than 10 percent of women who chose medication abortion experienced an adverse effect—including sepsis, infection, and severe hemorrhaging—requiring a visit to an emergency room. The new data track closely with similar figures in England and Wales that showed much the same results. "Medication abortion" refers to the abortion drug combination of mifepristone and misoprostol. Mifepristone is a synthetic steroid that prevents the nutrients necessary for fetal growth from reaching the unborn child, resulting in death. The second drug in the regimen, misoprostol, induces intense uterine cramping to expel the fetal remains. Mifepristone was developed by the French pharmaceutical company Roussel Uclaf in the 1980s. Also known as RU-486, mifepristone is marketed in the U.S. under the brand name Mifeprex. When it approved mifepristone, the FDA used an accelerated approval process known as "Subpart H," a category designated specifically for medications that "treat serious or life-threatening illnesses." Conditions that had previously qualified for the "H" designation included HIV/AIDS, cancer, and multiple myeloma—yet inexplicably pregnancy (which indicates that a woman's reproductive system is healthy and functioning) somehow also qualified. A woman dressed as a mifepristone pill dances with supporters of Planned Parenthood and pro-choice activists during a rally outside the US Supreme Court on April 2, 2025, in Washington, DC. A woman dressed as a mifepristone pill dances with supporters of Planned Parenthood and pro-choice activists during a rally outside the US Supreme Court on April 2, 2025, in Washington, DC. Drew ANGERER / AFP/Getty Images At the same time, the FDA's 2000 approval of mifepristone implicitly acknowledged the drug's risks by placing safety requirements on its use. These restrictions included mandating that only physicians could prescribe the mifepristone, imposing a seven-week gestational limit, and mandating that the pregnant woman participate in three separate in-person physician office visits—the first, so the doctor could personally administer the drug; the second, three days later, to personally administer misoprostol to induce the uterine cramping; and the third, at approximately two weeks post-abortion, to confirm that no fetal body parts or pregnancy tissue remained in the uterus and that bleeding had subsided. Finally, the FDA required providers of the abortion pill to report all adverse health events, like infection or excessive bleeding—not just deaths. In 2016, under the Obama administration, the FDA announced it had approved "major changes" to the dispensing of mifepristone that removed the initial protocols. The FDA eliminated the requirement for both follow-up appointments. It also changed the dosage directives and lifted the prohibition on non-doctors prescribing and administering mifepristone. The FDA also increased the gestational age limit of the unborn child being aborted from seven to ten weeks, and completely eliminated the previously required "non-fatal adverse event reporting," meaning that only deaths from mifepristone would be reported, not injuries to the woman—even serious ones. During the COVID pandemic, the FDA did not enforce the sole remaining in-person appointment required to dispense mifepristone; following the election of President Biden, the agency permanently dropped the in-person appointment requirement altogether, permitting women to receive the abortion drug through the mail. The new EPPC analysis shows a frightening pattern of harm caused to women by mifepristone. Women who undergo a medication abortion are more likely to present in an emergency room after taking the pills than a woman who has had a surgical abortion. Adverse outcomes range from sepsis caused by the retention of fetal tissue to fallopian tube rupture in women who have an ectopic pregnancy (a pregnancy that implants outside the uterus). It is because of those very risks that the FDA required medical oversight of mifepristone in the first place—to minimize the threat of serious side effects for pregnant women. By restoring the seven-week gestational age limit for chemical abortions and reinstating the mandatory doctor visits—along with the requirement to report complications and not just deaths—the FDA will better fulfill its mandate to protect Americans from harm. Mifepristone should be treated as the potentially dangerous drug that it is—not a political football. Mary FioRito is an attorney and the Cardinal Francis George Fellow at the Ethics and Public Policy Center. She resides in Chicago with her husband and three daughters. The views expressed in this article are the writer's own.
New York Post
28-04-2025
- Health
- New York Post
One in 10 chemical abortions end in serious health complications: report
Nearly 11% of women who have taken a chemical abortion pill in recent years have experienced a serious adverse health event — such as infection, hemorrhage or sepsis — according to a report from a conservative group that reviewed insurance claims data. The Foundation for the Restoration of America had a team of board-certified OB/GYN clinicians comb through more than 865,000 insurance claims related to chemical abortions between 2017 and 2023 — and found that at least 10.9% resulted in a serious adverse health event. In the final year of the review, that proportion jumped to 11.2% of chemical abortions having a serious adverse event — affecting tens of thousands of women. Advertisement The review also found that the rate of serious health complications is 'about 22 times' higher than stated on the label for the popular abortion pill mifepristone, which was originally approved by the Food and Drug Administration (FDA) in 2000. Mifepristone was initially approved by the Food and Drug Administration in 2000. Carl – Clinical trials previously cited by the FDA for the brand Mifeprex in 2023 said fewer than 0.5% of women suffered those complications. Advertisement 'Our data shows that chemical abortion poses greater risks to women in real-world clinical use than revealed in the clinical trials of mifepristone and that the rate of serious adverse events from the chemical abortion regimen continues to grow in recent years,' the report concluded. The Foundation for the Restoration of America identified at least 692,873 patients who obtained 865,727 chemical abortions from 2017 to 2023 for their review. The FDA initially OK'd mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama. Former President Joe Biden also opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year. Advertisement The Supreme Court unanimously rejected a challenge to mifepristone's widespread availability last year. AFP via Getty Images Dr. Christina Francis, a board-certified obstetrician and CEO of the American Association of Pro-Life OB/GYNs, told The Post Mifeprex's label downplays the potentially serious health complications — including sepsis, blood transfusion, hospitalization, infection, hemorrhage, uterine rupture, ruptured ectopic pregnancy and death. 'This should serve as an urgent safety signal for the FDA and is more consistent with what I see in clinical practice,' Francis said 'As a board-certified OB/GYN who has practiced for approximately two decades, I have cared for many women who have been lied to about the safety of abortion drugs and suffered significant complications from them,' she went on. Advertisement 'Women deserve fully informed consent about the dangers of these drugs and this data shows that more than 1 in 10 women who take them will suffer a severe complication,' she added. 'This is a public health crisis that should be further investigated immediately by the FDA — especially in light of its systematic removal of medical oversight from these drugs.' The Foundation for the Restoration of America was set up by Doug Truax, a former Senate Republican candidate from Illinois who is the founder and CEO of the health insurance group Everlong Group Medical Captive Services.
Yahoo
27-02-2025
- Health
- Yahoo
How RFK Jr. could restrict abortion medication access
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested that he is open to restricting access to abortion medication, the primary method used for abortions across the U.S. Kennedy pledged to study the abortion drug mifepristone on President Trump's request during his confirmation hearings, citing 'safety issues.' He did not offer further explanation of what those issues were. 'President Trump has asked me to study the safety of mifepristone,' Kennedy said during the hearings last month. 'He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.' If the administration does seek to restrict access to the drug, health policy experts do not think Kennedy will attempt to remove it from the market, but say he could instead try to direct agencies within HHS to limit who can take mifepristone and how it can be administered. 'If you are trying to make a product harder to access … you are going to institute restrictions that reduce the ease in which people can access the product,' said Caleb Alexander, a physician and professor at the Johns Hopkins Bloomberg School of Public Health with research focus on drug utilization and safety. HHS oversees 13 agencies including the Food and Drug Administration (FDA), which is responsible for protecting public health in part by making sure that the country's drug supplies are safe and effective for consumption. One way the FDA tries to ensure that medications are safe is by implementing Risk Evaluation and Mitigation Strategies (REMS). These are a series of rules the agency imposes on some drugs to prevent, monitor and manage the frequency or severity of adverse health events, according to the FDA's website. They can include some interventions to ensure the safe use of medication, like an in-person dispensing requirement. Mifepristone was previously under such a requirement until the Biden administration dropped it. Altering the REMS associated with the drug would be the most direct way to change who can take it and how, health experts said. Though changes to REMS are often requested by the drug manufacturer, the FDA can also determine if a change is needed, according to agency guidelines. It still typically needs to work with the drug producer in those cases, however. 'The FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication's benefits outweigh its risks,' the agency's website reads. To change REMS for a drug, the FDA would need to provide evidence that itposes a danger to people and that the current REMS do not protect consumers well enough from those risks, health experts said. The FDA first approved the abortion medication Mifeprex in 2000 and more than 100 studies conducted in at least 26 countries have found that most patients who have taken the drug have not experienced a serious complication like hospitalization or surgery. Typically, the process for changing REMS doesn't happen 'overnight,' according to Laurie Sobel, associate director of women's health policy at health research nonprofit KFF. But she suggestedthe process could be different under Trump, saying the administration could potentiallyissue an emergency declaration based on a study arguing that mifepristone is dangerous and revert back to earlier REMS for the drug. Such a move could eventually make it harder to access to drug by reinstituting rules thatallowed only certain clinicians the right to prescribe it, she said. Since 2000, the abortion medication has had a series of REMS that have been modified. The Biden-era FDA's announcement in 2021 that it woulddrop its requirement that the drug be dispensed in person to patients marked one of the more recent modifications. That requirement was officially dropped in 2023, with the agency releasing new REMS for the drug. In addition to seeking to roll back that change, the Trump FDA could also possibly suggest placing new requirements in the REMS that patients seeking mifepristone must undergo specific tests before they can be given the drug or be observed for a certain amount of time in clinic after it, according to Alexander. If the agency were to suggest changes to REMS for mifepristone, the drug's manufacturers Danko Laboratories and GenBioPro, which creates a generic version of the drug, would likely challenge the changes in court, health experts said. 'But it's unclear how successful that challenge might be,' said Sobel. The FDA did not answer questions from The Hill about REMS for mifepristone. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
