Latest news with #mifepristone
Washington Post
27-07-2025
- Health
- Washington Post
As state battles intensify, what's next for abortion pill access in U.S.?
The battle for abortion access in America, now concentrated in pharmacies and mailboxes, is headed toward a new reckoning in the nation's federal courthouses. Since the fall of Roe v. Wade three years ago, the number of abortions counted annually in the United States has risen, thanks largely to the growing availability of mifepristone and misoprostol. Medication abortions account for almost two-thirds of terminations involving a clinician, recent studies show — a 10-percentage-point leap from 2020.
Fox News
25-07-2025
- Health
- Fox News
FDA chief has no 'plans' for abortion pill policy changes but continues safety review
Food and Drug Administration Commissioner Marty Makary said in a recent interview he has "no preconceived plans" to modify policies surrounding abortion pill mifepristone, which is designed to end a pregnancy in the first 10 weeks. "We have an ongoing review of safety data on mifepristone, which is a requirement from the prior administrations," Makary said in an interview with POLITICO. "You always have to be open-minded. You have to listen to different opinions and make decisions based on what you think is the right thing to do." His comments mirror those he made during the Semafor World Economy Summit in April. During the summit, Makary said he has "no plans to take action" that would restrict the abortion drug's availability, but cautioned the agency wouldn't hesitate to act if the data suggested there was a safety issue. "There is an ongoing set of data that is coming into the FDA on mifepristone," he said. "So if the data suggests something or tells us that there's a real signal, we can't promise we're not going to act on that data." Sen. Josh Hawley, R-Mo., wrote an April 28 letter to Makary regarding safety concerns about mifepristone. "I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone. The health and safety of American women depend on it," Hawley wrote. Makary said during the interview with POLITICO that he has no plans to make "any changes" with policy regarding mifepristone, adding he would "continue to listen to folks that say they have concerns." Fox News Digital reached out to the FDA and Sen. Hawley for comment.
Reuters
23-07-2025
- Health
- Reuters
Missouri accuses Planned Parenthood of downplaying abortion drug risks
July 23 (Reuters) - Missouri's Republican attorney general filed a lawsuit on Wednesday accusing reproductive healthcare provider Planned Parenthood of misleading women about the potential risks of using the abortion drug mifepristone. The lawsuit, opens new tab by the office of Attorney General Andrew Bailey claims Planned Parenthood tells patients that the drug is 'safer than many other medicines like penicillin, Tylenol, and Viagra," while not disclosing that up to 4.6% of women visit emergency rooms after taking it. The lawsuit in Missouri state court accuses Planned Parenthood of violating a state law banning deceptive business practices. The state is seeking millions of dollars in penalties, including up to $1,000 for each woman in Missouri who has been provided abortion pills by Planned Parenthood over the last five years. "We are going to hold these charlatans and death dealers accountable," Bailey said in a social media post. Planned Parenthood did not immediately respond to a request for comment. Mifepristone is taken in tandem with another drug, misoprostol, during the first 10 weeks of pregnancy, and won approval from the U.S. Food and Drug Administration in 2000. Medication abortions account for more than half of U.S. abortions, though 28 states including Missouri restrict access, according to the nonprofit Guttmacher Institute, which focuses on reproductive health. The FDA has repeatedly called mifepristone safe and effective as demonstrated over decades of use by millions of Americans, with rare adverse effects. According to the FDA, between 2.9% and 4.6%, opens new tab of women who take the drug then visit an emergency room, and up to 0.6% of women who use mifepristone are hospitalized. A widely-cited 2021 study that purported to show an increase in emergency room visits after using mifepristone has been retracted, opens new tab. In Wednesday's lawsuit, Bailey's office said that newer studies conducted since the administration of former President Joe Biden eased some restrictions on accessing mifepristone identified serious adverse effects in more than 10% of women who took a single dose of the drug.
Washington Post
15-07-2025
- Health
- Washington Post
West Virginia's near-total abortion pill ban upheld by federal court
A divided federal appeals court on Tuesday allowed West Virginia to restrict access to mifepristone, the pill used to end pregnancies that has emerged as a focal point of legal battles over abortion. The decision marks the first time a federal appeals court has allowed a state to strictly limit the drug, teeing up a key test of states' powers to ban medication approved by the Food and Drug Administration.
Fox News
08-07-2025
- Health
- Fox News
Medical groups urge Kennedy, FDA to reexamine broad approval of abortion drugs
FIRST ON FOX: As Planned Parenthood sues the Trump administration for provisions of the Big, Beautiful Bill defunding abortion providers, pro-life medical groups are urging Health and Human Services Secretary Robert F. Kennedy Jr. to reexamine the FDA's broad approval of abortion drugs. In a letter obtained by Fox News Digital, six anti-abortion medical organizations, representing approximately 30,000 medical professionals, urge Kennedy and FDA Commissioner Martin Makary to reinstate safety guards on the abortion pill mifepristone that have been removed since it was first approved in 2000. According to the Guttmacher Institute, medication abortion accounts for 63 percent of all U.S. abortions. The most common form of medication abortion method involves ingesting mifepristone, a pill that cuts off progesterone flow to the womb, essentially starving the fetus of nutrients. A second pill, called misoprostol, is then ingested to expel the dead fetus. Under the Biden administration, the FDA significantly expanded its approval of mifepristone, allowing the drugs to be obtained via telemedicine, without in-person doctor appointments and to be mailed. In the letter, the groups, which include the American Association of Pro-Life OBGYNs, the Alliance for Hippocratic Medicine and the American College of Family Medicine, warn that the latest data on mifepristone "strongly suggests" that hundreds of thousands of women have been harmed by using the drug. Planned Parenthood states on its website that chemical abortion is "safer than many other medicines like penicillin, Tylenol, and Viagra." The letter, however, calls mifepristone "a high-risk abortion-inducing drug that is known to cause serious adverse effects and medical emergencies, including hemorrhage, sepsis, and incomplete abortions requiring surgical intervention." The letter cites two reports released this May, one by the Foundation for the Restoration of America and the other by the Ethics and Public Policy Center, that they say showed as many as one out of every nine women using mifepristone suffered serious adverse events. The studies claimed that, based on an analysis of health insurance records covering 330 million U.S. patients of 860,000 women receiving mifepristone prescriptions, 10.93 percent of those women experienced sepsis, infection, hemorrhaging, surgical intervention or another serious adverse event within 45 days following using the drug. Based on this, the letter says that real-world data on mifepristone use "shows real patients experience very real medical emergencies at an alarming rate – a rate that is consistent with what our members are seeing in their clinical practice." "The data strongly suggest that mifepristone poses a far greater risk of causing harm than previously stated. In fact, the risk of serious complications may be 22 times higher than previously disclosed," the letter states. In light of this, AAPLOG and the other groups signing onto the letter are urging the FDA to conduct its own evaluation of real-world data to determine the overall safety of mifepristone in both the adult and adolescent populations. The groups also urge Kennedy and Makary to reinstate reporting of all adverse events related to mifepristone use and reinstate the pre-2016 Risk Evaluation and Mitigation Strategies on the drug's use, including limiting the use of the drug to 7 weeks of gestation and requiring in-person dispensing as well as follow-up appointments. The letter stressed that requiring ultrasounds is also essential to confirm the gestational age of the fetus, which the groups said is "crucial to accurately dating a pregnancy and determining the risk of complications." "A basic tenet of medical ethics is informed consent — which requires a review of accurate risks and benefits of any proposed intervention that is specific to the patient sitting in front of us which is based on actual data, not ideologically-driven rhetoric," the letter states. "Women deserve to know the true risk of serious adverse events and medical emergencies after using mifepristone – no matter how politically charged the discussion surrounding this drug." "Americans must be able to trust that no matter what, the FDA will rely on the most robust safety standards before and after approving any drug and that they can have truly informed consent by knowing what the risks to taking FDA-approved drugs are," the letter says. The FDA's broad approval of mifepristone has been the subject of intense legal debate in recent years, including in the Supreme Court. In 2024, the Supreme Court dismissed a case brought by the Alliance for Hippocratic Medicine challenging the FDA's abortion pill approval on the grounds that the group lacked standing. At the time, Dr. Jack Resneck Jr., then president of the American Medical Association, claimed that restricting mifepristone "would have devastating health consequences for people living in states where abortion is still legal." Resneck Jr. claimed that "hundreds upon hundreds of peer-reviewed clinical studies and decades of evidence-based research disprove the assertions of the plaintiffs in this case and demonstrate the safety of mifepristone," which he said, "has a safety profile comparable to ibuprofen." After the Ethics and Public Policy report was released, Dr. Céline Gounder, a CBS News medical contributor and editor-at-large for public health at KFF Health News, disputed the findings, accusing the study of lacking transparency and not disclosing its data source, according to CBS. Gounder also said the study lacked a comparison group to examine how experiences compare to pregnant women not taking mifepristone. A spokesperson for Danco, mifepristone's manufacturer, also told the outlet that the company "stands confidently behind the product's established safety and efficacy record." In a statement emailed to Fox News Digital, Dr. Christina Francis, an OB-GYN and CEO of AAPLOG, said that the FDA's deregulation of mifepristone "subjects pregnant women to an unacceptably low standard of care, leaving them vulnerable to life-threatening complications, and empowers abusers and traffickers who wish to force unwanted abortions on their victims." "Our doctors have seen the devastating impact this recklessness has had on patients, which makes clear the dire need for the FDA to reprioritize women and girls by reexamining the drug's safety and reinstating basic safeguards that should never have been lifted," she said. The other groups that signed onto the letter are the Christian Medical and Dental Association, the American College of Pediatricians and the Coptic Medical Association of North America.
