Many Americans wonder whether the pill used in most U.S. abortions will be restricted under the new Republican administration in Washington.
President Donald Trump’s pick to lead the Food and Drug Administration, Dr. Marty Makary, was confirmed by the Senate this past week. In recent testimony before the Senate health committee, Makary wouldn’t commit to specific action on the pill, called mifepristone, despite prodding from both Republicans and Democrats.
Mifepristone tablets are seen in a Planned Parenthood clinic July 18, 2024, in Ames, Iowa.
Medical professionals call it “among the safest medications” ever approved by the FDA. But a Christian conservative group that sued the FDA over the drug says it has caused “tens of thousands” of “emergency complications."
Here’s what to know about the safety of mifepristone, which is typically used with misoprostol in medication abortions that make up close to two-thirds of abortions in the U.S.
What are the safety limits on use of the abortion pill?
The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Currently, there are no in-person requirements and the pill can be sent through the mail.
That's not how the FDA first treated mifepristone, which on rare occasions can cause dangerous, excessive bleeding that requires emergency care. Strict safety limits were placed on who could prescribe and distribute it — only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug. The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn’t end the pregnancy.
Over time, the FDA reaffirmed mifepristone’s safety and repeatedly eased restrictions.
How often are there serious problems?
Abortion opponents say the FDA’s 2021 decision allowing online prescribing and mail-order use of mifepristone resulted in many more “emergency complications.”
But that argument lumps together women experiencing a range of issues — from mifepristone not working to people who may simply have questions or concerns but don’t require medical care.
OB-GYNs say a tiny fraction of patients suffer “major” or “serious” adverse events after taking mifepristone.
A legal brief filed with the Supreme Court last year by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events — significant infection, excessive blood loss, or hospitalization — occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.”
The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study.
The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.” It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.
Why do patients go to the emergency room?
Mifepristone’s labeling lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain or a sustained fever. But ER visits don’t always reflect big problems.
Some people may go there after a medication abortion because they want to be checked out or have questions but don’t have a doctor, said Upadhyay, a public health scientist at the University of California, San Francisco. Others, she said, “don’t want to go to their primary care provider about their abortion” because of stigma.
A study she co-authored in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care.
How effective is the pill?
Mifepristone results in a completed abortion 97.4% of the time, according to U.S. studies cited in the FDA label.
But in 2.6% of cases, a surgical intervention is needed. And 0.7% of the time, the pregnancy continues.
That’s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy “is extremely, extremely low,” probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.
“Any time a procedural abortion is done, the clinicians ensure that it was a complete abortion” by examining the tissue that is removed or performing an ultrasound during or after the procedure, she said.
Gupta, who has done abortion procedures for more than 20 years, said there are “very few complications from abortion — any kind of abortion, medication or procedural abortion.”
One study suggested that’s just as true for medication abortions that happen in a clinic, a doctor’s office or at home with the help of telehealth.
How does mifepristone’s safety and effectiveness compare to other drugs?
The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.
No drug is 100% effective, and many common medications don’t work for a significant portion of patients.
Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often resolve about 70% of infections.
Since 2000, roughly 6 million patients have taken mifepristone, according to the FDA. A 2021 review of agency records looking for deaths that were likely related to the drug identified 13, or 0.00027% of patients.
These states already restrict abortion. Their legislatures could push it even further.
These states already restrict abortion. Their legislatures could push it even further.
Updated
Conservative state lawmakers are prepared to press for more abortion restrictions this year, regardless of any action President Donald Trump pursues in office. Many of the bills filed in state legislatures across the country focus on abortion pills, abortion access for minors, and, in at least one state, how to undo protections for the procedure, The 19th reports.
Legislators in Indiana, Missouri, Oklahoma, South Carolina, Texas, and Tennessee have filed bills that would further curb access. In states with near-total bans, lawmakers are looking to eliminate the workarounds residents have used to continue accessing abortions. In others, lawmakers will weigh whether to move from six-week abortion bans to almost completely outlawing the procedure. And in Missouri, where voters just amended the constitution to enshrine abortion rights, some legislators are pushing to reverse or weaken the new democratically established protection.
Because state legislatures often influence each other, more bills are almost certain to follow.
It's still unclear what appetite Trump has for federal abortion regulations. Anti-abortion organizations are still lobbying for the second Trump administration to restrict abortion rights, and several of the president's Cabinet members have made their opposition to abortion clear. Yet Trump himself has been inconsistent about how he would approach the issue. In his first term, he was a steadfast ally for abortion opponents. But on the 2024 campaign trail, he claimed he would veto any proposed national ban, even while taking credit for the fall of Roe v. Wade.
State lawmakers aren't waiting for the new president to clarify his approach, and many have taken Trump's election as validation to pursue new restrictions.
"It emboldened anti-abortion legislators," said Jennifer Driver, senior director of reproductive rights at the State Innovation Exchange, which advocates for progressive policy in statehouses. "It pushed the limit."
In Texas, the largest state to ban abortion, the 2024 election eliminated the fear that pushing for new restrictions would result in political blowback, said John Seago, the head of Texas Right to Life, an influential anti-abortion organization. "It took the political excuses off the table," he said.
Medication Abortion
Bills filed so far suggest a focus on further limiting access to medication abortion, the two-drug regimen that can safely be taken from home with virtual medical oversight if needed. Pregnant people in states with bans have relied on medication—in some cases prescribed and mailed by a health care provider in a state with abortion protections—to terminate their pregnancies.
The practice of having pills mailed to states with bans is medically safe but legally fraught. Health care providers typically are only protected when in their home states, and while abortion bans don't criminalize patients, those who receive medication can risk prosecution under other state laws. Still, it's created an effective enough workaround that abortion opponents are hunting for a way to end this virtual health care model.
"It's about the trafficking of abortion pills, whether that's through the mail, whether that's physicians bringing them over the border and distributing them—those are really what we're focusing on," Seago said. "The fact that these trends have been going on for the past couple of years without accountability is something we seek to change this year."
Bills targeting abortion pills have been introduced in Texas and Tennessee, where abortion is illegal in almost all cases. They have also been introduced in Indiana, where abortion is illegal after six weeks.
Texas lawmakers have already introduced bills that would ban selling abortion pills online; those who sell or distribute the medications through the Internet could be found guilty of a felony. Legislators in Indiana and Tennessee have also targeted distribution of these drugs; an Indiana bill would outlaw possessing abortion medication or sending it to someone else, and a Tennessee bill would ban mailing abortion pills. Another Indiana bill would also reclassify abortion pills as "controlled substances"—a classification that goes against medical evidence but takes a similar approach to a law enacted last year in Louisiana. A separate Texas bill would also classify those medications as controlled substances, which is typically designated for drugs with significant potential for abuse, such as narcotics, and can involve greater penalties for possession.
In Wyoming, where abortion is legal until fetal viability, a Republican-backed bill would require patients to receive an ultrasound before receiving abortion medication—a measure that is out of step with most major medical organizations' advice, but that would effectively outlaw providing medication through telehealth.
Such restrictions could have sweeping consequences for anyone who becomes pregnant. Mifepristone and misoprostol are also used to treat miscarriages, which typically require the same standard of care as an abortion.
It's not clear which specific bills will make it to their respective governors' desks—in Texas, Seago, said, his organization expects more medication-specific legislation to be filed in the state Senate, including the bills they will most actively champion—but they signal a clear interest in medication and its particular role in helping people circumvent abortion bans.
That will also likely mean efforts to target the medical providers who have helped patients receive medication abortions. Many have relied on shield laws, or statutes saying their home state will not comply with another state's effort to prosecute them for providing abortion-related health care. The laws are still relatively new and have not yet been tested in court.
"We are going to see more attacks on shield laws," said Elisabeth Smith, the director of state policy and advocacy at the Center for Reproductive Rights, a legal advocacy group that has challenged state abortion laws in court. "We're going to see more attacks on providers."
That focus has already begun to take form outside of state capitols. Ken Paxton, Texas' attorney general, filed a lawsuit in December targeting a New York-based physician who allegedly prescribed and mailed abortion pills to a woman in Texas.
The case is a first test of whether existing state abortion bans can be leveraged to penalize people who live outside of their state lines, or if these bans will be thwarted by shield laws like New York's. More such lawsuits are likely, Seago said, a view other abortion law scholars and observers echoed. A successful case could halt or substantially undercut the practice of telehealth provision to people in states with abortion bans.
"This is a test case. They'll see how this goes, and I'm sure there will continue to be more challenges like this," said Greer Donley, a law professor at the University of Pittsburgh who studies medication abortion law.
New Barriers for Minors
While medication and its virtual prescription remain abortion opponents' top priority, legislators are also looking to other avenues that could further weaken access to or awareness of abortion, particularly for young people.
A bill in Mississippi, where abortion is illegal in almost all cases, would prohibit acquiring abortion medication for a minor or transporting the minor out of the state for an abortion without the consent from the patient's parents or guardians. A bill in New Hampshire, where abortion is legal until 24 weeks of pregnancy, also targets young people by proposing to outlaw transportation of a minor for an abortion without their parents' or guardians' consent.
One in South Carolina would outlaw almost all abortions—rather than the six-week ban that currently exists—by removing exceptions for cases of rape and incest, and making it harder for minors specifically to get abortions. The bill would eliminate judicial bypass, which judges can grant to minors whose parents or guardians do not give consent to have an abortion.
Undoing Abortion Protections
Missouri's abortion rights measure passed in November, with 51.6% voting in favor. If lawmakers can successfully weaken it—slow-walking implementation, redefining it to offer less protection, or passing a new constitutional amendment that reverses it—those efforts could offer a model for other anti-abortion states.
Lawmakers are seeking to reverse a decision by voters to enshrine abortion rights until fetal viability in the state constitution—introducing proposals to re-amend the state's constitution in opposition to abortion rights, one to ban abortion at six weeks and another to criminalize the possession of abortion medication.
Speaker of the House Jonathan Patterson has floated the idea of redefining "fetal viability" to potentially earlier in pregnancy. Medically, a fetus is considered viable when it can live independently outside the uterus, typically around 23 to 25 weeks. But anti-abortion opponents have been trying to argue that the number falls earlier—some suggesting around 15 weeks—even though that has no medical basis. Patterson has not said when the legislature would seek to define viability.
The legality of some of those efforts is questionable, as is whether Missouri's state court system will allow these efforts to take effect.
Since Roe's overturn, reproductive rights supporters have relied on direct democracy, asking voters to amend their state constitutions to protect abortion, to undo prohibitions on the procedure. Those efforts have succeeded in states including Arizona, Michigan, Montana, Nevada, and Ohio, as well as in more reliably liberal states such as California, Colorado, Maryland, New York, and Vermont. In Florida, an abortion rights measure received 57% of voter support—a share that would have been enough in other states, but shy of the 60% required to amend the state constitution. It was the first abortion rights measure to fail since the fall of Roe.
But many states do not allow for a citizen-initiated ballot measure process. Only four states that allow ballot measures—Arkansas, Idaho, North Dakota, and Oklahoma—have not yet had an abortion rights proposal before voters.
This story was produced by The 19th and reviewed and distributed by Stacker.
