Latest news with #mifepristone
Reuters
14 hours ago
- 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 A widely-cited 2021 study that purported to show an increase in emergency room visits after using mifepristone has been retracted, opens new tab.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.
Medscape
26-06-2025
- Health
- Medscape
Mifepristone Improves A1C in T2D With Hypercortisolism
CHICAGO — Mifepristone treatment improved glycemic control and led to weight loss and a reduction of waist circumference in patients with poorly controlled type 2 diabetes (T2D) and hypercortisolism, according to new data from the CATALYST trial. Results from the prevalence phase of the study, presented last year, indicated that 24% (253) of the 1055 patients enrolled had hypercortisolism, as determined by dexamethasone suppression test. The figure was surprising, as the expected prevalence was 8%. The current data were presented at the American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in Diabetes Care . 'These findings demonstrate a potentially promising treatment solution' for these patients, who are often frustrated with their diabetes care, said study author John Buse, MD, PhD, Verne S. Caviness Distinguished Professor of Medicine at the University of North Carolina School of Medicine, Chapel Hill, North Carolina, in a press release. The CATALYST Trial: Latest Results In the second phase of CATALYST, individuals who had abnormal cortisol suppression were offered the opportunity to take part in a randomized trial of mifepristone, a medication that reduces the effects of cortisol. It is currently FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or T2D. The trial took place at 36 sites in the US. A total of 136 patients with T2D (A1c of 7.5%-11.5%, who were on multiple medications) and hypercortisolism were randomized 2:1 to mifepristone (300-900 mg once daily; 91 patients) or placebo (45 patients) for 24 weeks, with stratification by presence/absence of an adrenal imaging abnormality. Almost 40% of the patients were women, and the mean age was 63 years. The mean A1c was 8.55%, and mean BMI was 33.3. Twenty-eight percent of participants had adrenal imaging abnormalities. The medication reduced A1c by 1.5% (95% CI, -1.79 to -1.14). For those taking placebo, A1c declined 0.2% from 8.41% to 8.36% (95% CI, -0.56 to 0.27). Within the first 12 weeks, 30% of those taking mifepristone reduced or discontinued fast-acting insulin compared to 11% of those taking placebo. And half reduced or discontinued long-acting insulin compared to 13% of those taking placebo. 'As their A1c came down, they didn't need the insulin,' Buse told reporters at a press conference at the meeting. Patients taking mifepristone also lost 4.4 kg of body weight and had a 5.2 cm (2.05 in) reduction in waist circumference from baseline. However, almost 50% of those taking mifepristone discontinued due to adverse events compared to just 18% of those taking placebo. A total of 62% of patients on mifepristone reported having treatment-related adverse events, said Buse, adding that people on mifepristone primarily experience glucocorticoid withdrawal syndrome or hypokalemia. Mifepristone 'is a challenging drug to use,' he said, and 'it's important to set expectations appropriately with patients about steroid withdrawal symptoms and how to manage them.' CATALYST already demonstrated that hypercortisolism was likely a culprit in almost a quarter of patients with poorly controlled diabetes, and screening with a dexamethasone suppression test is relatively easy, said Buse. The treatment phase of CATALYST showed 'that identifying and addressing hypercortisolism is a novel path to improving diabetes care in millions of people worldwide,' he added. The CATALYST investigators 'believe that there's sufficient evidence now to suggest guideline changes at the American Diabetes Association and other international health organizations.' This study was funded by Corcept Therapeutics. Buse disclosed serving on an advisory panel/as a consultant for Altimmune, Antag Therapeutics, Amgen, APstem Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Dexcom, Eli Lilly, embecta, GentiBio, Glyscend, Insulet, Medtronic MiniMed, Mellitus Health, Metsera, Novo Nordisk, Pendulum Therapeutics, Praetego, Stability Health, Tandem Diabetes Care, Terns Pharmaceuticals, Vertex Pharmaceuticals, and Zealand Pharma; and having stocks/shares in Glyscend, Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, and Stability Health.
New York Times
09-06-2025
- Health
- New York Times
A Day With One Abortion Pill Prescriber
The young woman's voice trembled over the phone. Sitting in her car in Alabama, where abortion is almost totally banned, the 26-year-old mother of two was grappling with an unintended pregnancy. 'I'm like 'How in the world?'' she said, stifling a sob. 'I already have two children, and I cannot. I can't. I just can't go through with it.' She wanted an abortion, she said, but was afraid of getting caught and didn't know what to expect from the process. 'Growing up, I never really thought about actually doing something like this,' she said. On the other end of the line, at home on a quiet residential street in Delaware, Debra Lynch, a nurse practitioner who runs a service prescribing abortion pills, spoke calmly. 'It's completely valid to be scared,' she said from her desk in a home office filled with plants and shelves of medication. 'And that's why we want you to call us, even if you're calling just to say: 'I'm scared. I need to hear somebody tell me that what's going on right now is normal, and it's OK.'' During the 25-minute conversation, Ms. Lynch asked the woman about her health history and pregnancy and assessed that she was medically eligible for abortion medications that can be taken in the first 12 weeks of pregnancy: mifepristone, which blocks a hormone necessary for pregnancy development, and misoprostol, taken 24 to 48 hours later, which causes contractions so pregnancy tissue can be expelled. Want all of The Times? Subscribe.
