The federal Emergency Medical Treatment and Labor Act, known as EMTALA, requires hospitals to provide medically necessary care to stabilize patients in emergency situations.One of the newest battlefields in the abortion debate is a decades-old federal law called the Emergency Medical Treatment and Labor Act, known by doctors and health policymakers as EMTALA.The issue involves whether the law requires hospital emergency rooms to provide abortions in urgent circumstances, including when a woman’s health is threatened by continuing her pregnancy. But, as with many abortion-related arguments, this one could have broader implications. Some legal experts say it could potentially determine how restrictive state abortion laws are allowed to be and whether states can prevent emergency rooms from providing other types of medical care, such as gender-affirming treatments.The Biden administration is in the middle of legal battles over the law with the states of Texas and Idaho. The Supreme Court has agreed to hear the Idaho case.What does the law do?Enacted by Congress in 1986, EMTALA (pronounced em-TAHL-uh) requires hospitals across the country to guarantee all patients a standard of emergency care, regardless of whether they have insurance or can pay. The law, which was passed to address concerns that hospitals were failing to screen, treat or correctly transfer patients, applies to any hospital that receives Medicare funding and has an emergency department — most hospitals in the United States.Specifically, the law says that if a patient goes to an emergency room with an “emergency medical condition,” hospitals must either provide treatment to stabilize the patient or transfer the patient to a medical facility that can. Hospitals that violate the law can face consequences including fines and exclusion from further Medicare funding.What does that have to do with abortion?The law does not mention abortion or name specific treatments for any emergency medical condition. It requires only that hospitals use accepted medical approaches for each patient. But soon after the Supreme Court overturned the national right to abortion in June 2022, the Biden administration issued a memorandum saying that EMTALA applies in cases where abortion is necessary to stabilize a patient.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? 

The newsWomen who experience depression during pregnancy or in the year after giving birth have a greater risk of suicide and attempted suicide — risks that persist for years, two new studies report.Travis Dove for The New York TimesWhat the research showsA research team analyzed records of nearly a million women in Sweden’s national medical registries from 2001 through 2017, comparing 86,551 women who had perinatal depression with 865,510 women who did not. The groups were matched by age and year they gave birth.In two studies, the team found that depression that begins in pregnancy or soon after can have troubling implications for as long as 18 years.One study, published on Tuesday in JAMA Network Open, found that women with perinatal depression had three times the risk of suicidal behavior, defined as attempted or completed suicide, than women who did not experience perinatal depression. Risks were greatest in the year following their diagnosis, but, while they lessened over time, years later the risks were still twice as high compared with women without the disorder.The other study, published on Wednesday in BMJ, found that women with perinatal depression were more than six times at risk of dying by suicide as those without that diagnosis. The number of suicides was small, but it accounted for a large share of the deaths of women diagnosed with perinatal depression: 149 of the 522 deaths in that group, or 28.5 percent. For women without perinatal depression, there were 117 suicides out of 1,568 deaths or 7.5 percent.Suicide was a major reason women with perinatal depression were twice as likely to die from any cause over the 18-year period of the study compared with women without the disorder.The researchers also compared more than 20,000 women with perinatal depression to their biological sisters who gave birth during the same time frame and did not have the disorder. The risk of suicidal behavior for the sisters with perinatal depression was nearly three times that of their sisters without the diagnosis — almost as high as the difference between women with the illness and those without it to whom they were not related. That suggests depression plays a greater role in these outcomes than genetics or childhood environment, the researchers wrote.Behind the numbersThe average age at which women experienced perinatal depression was 31. They were more likely than those without the illness to live alone, to have lower income and less formal education, to have smoked recently and to have not given birth before, among other characteristics, the researchers reported.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? 

The NewsTens of thousands of women who are not pregnant are ordering abortion pills just in case they might need them someday, especially in states where access is threatened, according to a study published on Tuesday.After the Supreme Court overturned Roe v. Wade, more women began ordering abortion pills just in case they became pregnant, especially in states where abortion access was under threat.Evelyn Hockstein/ReutersWhy It MattersThe practice, known as advance provision, is relatively new and has increased significantly since the Supreme Court’s decision in 2022 to overturn the national right to abortion.In the study, published in the journal JAMA Internal Medicine, researchers evaluated data from Aid Access, a telehealth organization that has long provided abortion pills to women in the first 13 weeks of pregnancy and began offering the medication to women in the United States who weren’t pregnant in September 2021.Before May 2022, when a draft of the Supreme Court decision was leaked, Aid Access had received about 6,000 advance provision requests, averaging 25 per day. Since then, it has received over 42,000 requests, averaging 118 per day, said Dr. Abigail Aiken, an associate professor at the University of Texas at Austin and a co-author of the study.The biggest spikes in demand followed events that raised doubts about the future availability of abortion. Requests peaked in the weeks between the leak and the Supreme Court’s decision in June 2022, and in April 2023 after a flurry of court rulings in a lawsuit by abortion opponents seeking to curtail mifepristone, a key abortion pill, a case now before the Supreme Court.Rates of requests were highest in states where abortion bans were expected — even higher than in states that already had bans. Asked why they requested the pills, most women said to “ensure personal health and choice” and “prepare for possible abortion restrictions,” according to the study.“People were obviously paying attention and seeing the threat of abortion access either going away or being reduced where they were and thinking, ‘I need to get prepared for that,’” Dr. Aiken said.Behind the NumbersData from September 2021 through April 2023 showed 48,404 advance provision requests and 147,112 requests from women seeking to terminate existing pregnancies. (Women in both categories completed telehealth consultations and Aid Access evaluated their medical information before prescribing pills.)Advance provision requesters were more likely than those already pregnant to be 30 or older, white and childless, and to live in urban neighborhoods with lower poverty rates than the national average. That might be partly because Aid Access offers free or reduced-price services to pregnant patients who need financial assistance, while advance provision requesters were expected to pay the full $110 cost, Dr. Aiken said.And because few organizations offer advance provision, women from marginalized or lower-income communities might be less aware “that it’s even a thing you can do,” she said.Medication abortion typically involves two pills: mifepristone, which has a shelf life of three to five years, followed a day or two later by misoprostol, which has a shelf life of 18 to 24 months.Dr. Aiken said a subset of advance provision requesters — 937 women, two-thirds of them in states with abortion bans or restrictions — answered follow-up questions. Most still had the pills, but 58 had taken them and 55 had given them to someone else.About 60 percent took the pills before seven weeks of pregnancy, early in the recommended time frame. A vast majority reported having enough information, including about expected bleeding and cramping. All 58 said the pills worked. Five visited health care providers afterward, but none went to the hospital or had serious complications.Larger ImplicationsLegal scholars say advance provision may be legal in some states with abortion bans. “Many state abortion laws require a provider to know a person is pregnant,” three law professors — David S. Cohen, Greer Donley and Rachel Rebouché — wrote in an article to be published in the Stanford Law Review. However, they added, in some states, abortion providers might be legally vulnerable since they know that “the pills are prescribed to terminate a future pregnancy.”Abortion opponents object to advance provision and claim abortion medication is dangerous. Abortion rights supporters say prescribing it in case of future need, like antibiotics for traveler’s diarrhea, increases access and underscores that the pills are safe, as many studies show.

The NewsA team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.A colored transmission electron micrograph showing an intestinal endocrine cell, with granules containing serotonin in green.Steve Gschmeissner/Science SourceWhy It Matters: New ways to diagnose and treat long Covid.This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.“All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, a lead author of the study and an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.“Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he said.“This is an excellent study that identifies lower levels of circulating serotonin as a mechanism for long Covid,” said Akiko Iwasaki, an immunologist at Yale University. Her team and colleagues at the Icahn School of Medicine at Mount Sinai recently published a study that identified other biological changes linked to some cases of long Covid, including levels of the hormone cortisol. These studies could point to specific subtypes of long Covid or different biological indicators at different points in the condition.The Back Story: A series of disruptions set off by bits of virus in the gut.Researchers analyzed the blood of 58 patients who had been experiencing long Covid for between three months and 22 months since their infection. Those results were compared to blood analysis of 30 people with no post-Covid symptoms and 60 patients who were in the early, acute stage of coronavirus infection.Maayan Levy, a lead author and assistant professor of microbiology at the Perelman School of Medicine, said levels of serotonin and other metabolites were altered right after a coronavirus infection, something that also happens immediately after other viral infections.But in people with long Covid, serotonin was the only significant molecule that did not recover to pre-infection levels, she said.The team analyzed stool samples from some of the long Covid patients and found that they contained remaining viral particles. Putting the findings in patients together with research on mice and miniature models of the human gut, where most serotonin is produced, the team identified a pathway that could underlie some cases of long Covid.Here’s the idea: Viral remnants prompt the immune system to produce infection-fighting proteins called interferons. Interferons cause inflammation that reduces the body’s ability to absorb tryptophan, an amino acid that helps produce serotonin in the gut. Blood clots that can form after a coronavirus infection may impair the body’s ability to circulate serotonin.Depleted serotonin disrupts the vagus nerve system, which transmits signals between the body and the brain, the researchers said. Serotonin plays a role in short-term memory, and the researchers proposed that depleted serotonin could lead to memory problems and other cognitive issues that many people with long Covid experience.“They showed that one-two-three punch to the serotonin pathway then leads to vagal nerve dysfunction and memory impairment,” Dr. Iwasaki said.There are caveats. The study was not large, so the findings need to be confirmed with other research. Participants in some other long Covid studies, in which some patients had milder symptoms, did not always show depleted serotonin, a result that Dr. Levy said might indicate that depletion happened only in people whose long Covid involves multiple serious symptoms.What’s Next: A clinical trial of Prozac.Scientists want to find biomarkers for long Covid — biological changes that can be measured to help diagnose the condition. Dr. Thaiss said the new study suggested three: the presence of viral remnants in stool, low serotonin and high levels of interferons.Most experts believe that there will not be a single biomarker for the condition, but that several indicators will emerge and might vary, based on the type of symptoms and other factors.There is tremendous need for effective ways to treat long Covid, and clinical trials of several treatments are underway. Dr. Levy and Dr. Thaiss said they would be starting a clinical trial to test fluoxetine, a selective serotonin reuptake inhibitor often marketed as Prozac, and possibly also tryptophan.“If we supplement serotonin or prevent the degradation of serotonin, maybe we can restore some of the vagal signals and improve memory and cognition and so on,” Dr. Levy said.

New cases say fear and confusion about abortion bans in three states are causing doctors and hospitals to deny medically necessary abortions.Early in her pregnancy, Jaci Statton was in her kitchen when she felt like she was going to pass out and saw that her jeans had become soaked with blood. Doctors told her the pregnancy was not viable and that it could threaten her life if an abortion was not performed soon, she said.But Ms. Statton lives in Oklahoma, a state that bans most abortions. Three hospitals declined to provide the procedure, she said. At the third, “they said, ‘We can’t touch you unless you’re like crashing in front of us,’” Ms. Statton, 26, said in an interview. The hospital’s only suggestion, she said, was “we should wait in the parking lot until I was about to die.”On Tuesday, Ms. Statton filed a legal complaint with the U.S. Department of Health and Human Services asserting that the third institution, Oklahoma Children’s Hospital, had violated a federal law that requires hospitals with emergency departments to provide abortions in urgent situations, regardless of state abortion restrictions.Her case is part of several legal challenges filed Tuesday involving patients and doctors in three states — Idaho, Tennessee and Oklahoma — who claim that those states’ abortion bans are preventing women with serious pregnancy complications from getting abortions, even in cases where the medical need is clear.The cases, filed by the Center for Reproductive Rights, a legal advocacy organization, represent a broadening of legal strategies that abortions rights groups have initiated in recent months, after last year’s Supreme Court decision overturning the national right to abortion.Jaci Statton and her husband, Dennis, before her pregnancy.Rachel Meagan PhotographyWith 14 states to date enacting laws that outlaw most abortions, some abortion rights advocacy groups are focusing on cases involving patients with desired pregnancies that developed serious complications or abnormalities. The cases don’t seek to strike down the bans but instead to gain legal clarity ensuring that patients in these situations should be exempt from state abortion bans.The groups argue that the vague wording in the laws and the widespread confusion and fear among doctors that they could be prosecuted or penalized, has resulted in the denial of care, with sometimes dire consequences to patients’ health or ability to become pregnant in the future.One legal strategy, initiated earlier this year with a lawsuit filed against the State of Texas on behalf of patients and doctors, seeks clarification about state abortion restrictions to allow doctors to terminate pregnancies for patients with medical emergencies or severe fetal anomalies. The lawsuits filed Tuesday against Tennessee and Idaho echo that approach.Another strategy — invoked in Ms. Statton’s case — asks the federal government to investigate hospitals that have denied abortions to patients with medical emergencies in states with abortion bans. This spring, in a first-of-its-kind action, the federal government told a hospital in Missouri and another in Kansas that they had violated the federal law, the Emergency Medical Treatment and Labor Act, or EMTALA, when they denied an abortion to a woman whose water broke 17 weeks into her pregnancy. That law requires hospitals that receive Medicare funding and have emergency rooms to provide treatment including abortions if necessary to stabilize patients. Ms. Statton’s complaint asks the federal agency responsible for enforcing EMTALA, the Centers for Medicare & Medicaid Services, to investigate Oklahoma Children’s Hospital and issue a finding that it violated that law. The potential consequences include fines and exclusion from Medicare funding.OU Health, which includes Children’s Hospital, said in a statement: “Our health care complies with state and federal laws and regulatory compliance standards.”The Centers for Medicare & Medicaid Services did not provide a comment.In a news conference on Tuesday, leaders of the Center for Reproductive Rights said that the limited exceptions in state abortion bans were written with terminology doctors do not use and that they made it unclear when doctors might be at risk of punishment.“What these laws are forcing physicians to do is to weigh the very real threats of criminal prosecution against the health and well-being of their patients,” said Nancy Northup, the group’s president.Officials from two anti-abortion groups said that state abortion bans already allowed exceptions in life-threatening emergencies and that abortion rights advocates were trying to sow confusion. Dr. Ingrid Skop, vice president and director of medical affairs at the Charlotte Lozier Institute, said that although she never performed elective abortions, “there have been times I have needed to separate a mother from her unborn child in order to preserve her life in an emergency.”In the Texas case, after a hearing in July in which several women gave tear-filled testimony, a judge issued a temporary exemption to the state’s abortion ban that would allow patients with serious pregnancy complications to obtain abortions, but the exemption was blocked when the state immediately appealed. The case is scheduled for trial next year.The lawsuits filed Tuesday against Tennessee and Idaho — which include eight patients, four doctors and an Idaho medical organization — not only ask for clarification about which situations qualify as medical emergencies eligible for abortions but also ask the states’ courts to expand the exemptions so that pregnancies with lethal fetal anomalies can be legally aborted.The plaintiffs in the Tennessee case include Nicole Blackmon, who said she was 15 weeks pregnant when she learned that the fetus had a fatal medical condition. Tennessee’s abortion ban does not include exceptions for severe fetal anomalies, so she could not receive an abortion in the state. Ms. Blackmon could not afford to travel to another state, and at seven months into her pregnancy, after her health was worsening, gave birth to a stillborn baby, she said at Tuesday’s news conference.“That law forced me to carry a baby for months that was never going to live and easily could have killed me,” said Ms. Blackmon, who said that shortly before she became pregnant last year, her 14-year-old son Daniel was killed in a drive-by shooting. “I was left with waiting to lose another child in the same year,” she said.Tennessee’s attorney general’s office said it had not yet received the center’s lawsuit and will review it when it does.In Oklahoma, Ms. Statton, a mother of three, first went to a local Catholic hospital, which told her she was having a miscarriage. The next day she visited her obstetrician-gynecologist, who determined that she had a partial molar pregnancy, a condition in which an egg has been fertilized by two sperm, creating an embryo with too many chromosomes, which cannot survive. The condition can cause the development of precancerous sacs or cysts in the uterus, which can rupture and cause severe bleeding or can develop into cancer.Ms. Statton said the doctor told her “it will get worse” unless she had an abortion to remove the tissue, but because the hospital was Catholic, the doctor could not perform the procedure.She transferred Ms. Statton to University of Oklahoma Medical Center, about an hour away in Oklahoma City.There, Ms. Statton, who was about nine weeks pregnant, said doctors told her she should have the abortion immediately, but an ultrasound technician told them that they could not provide it because fetal cardiac activity could still be detected. “They were arguing with the ultrasound tech,” Ms. Statton said, and the doctors ultimately “came back in the room and said ‘We can’t.’”They transferred her to Oklahoma Children’s Hospital, part of the same health system, saying that it had specialty care that might allow it to treat her. When staff at that hospital said they could not provide an abortion until her condition became worse, her husband began to cry, saying, “‘I’m going to lose you, I’m going to lose our baby,’” Ms. Statton said.They drove 180 miles to an abortion clinic in Kansas, afraid that on the way her condition would deteriorate, Ms. Statton said. The clinic performed the abortion. Soon after , Ms. Statton decided to have a tubal ligation to prevent future pregnancies and she recently began taking antidepressants for the first time, she said.Ms. Statton said that when her state banned abortion she didn’t think about it much because “I would keep my baby so I wouldn’t need that.”Now, she said, “I just want other women to know that if they go through something like this, they’re not alone and it’s not their fault.”

The new ruling will have no effect on access until the Supreme Court ultimately decides the case.A federal appeals court panel said Wednesday that it would impose restrictions on the abortion pill mifepristone that would prevent the drug from being prescribed by telemedicine or dispensed through the mail.But the decision — the latest development in a closely watched lawsuit filed by abortion opponents seeking to block access to abortion pills — will not take effect until the Supreme Court ultimately decides the case.In a ruling this spring, the high court said mifepristone should remain available under the current rules until the appeals process concludes.In its ruling, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit upheld part of a decision issued in April by a federal judge in Texas. That decision, by Judge Matthew J. Kacsmaryk, had nullified the Food and Drug Administration’s approval of the pill 23 years ago.But the appeals court decision on Wednesday kept the F.D.A.’s approval in place. It also kept in place a later approval of the generic version of the drug, which is now used in the most medication abortions.The main impact of the appeals court decision, if it is upheld by the Supreme Court, would be to reverse changes made by the F.D.A. in recent years that allowed patients to obtain the pill without visiting a doctor or other health provider in person. It would mean that patients would have to make three medical visits and could not receive the pills in the mail.The ability for patients to use telemedicine and obtain the prescribed pills through the mail has significantly expanded the use of medication abortion, which is now used in more than half of pregnancy terminations in the United States.

Because the pill works faster than other antidepressants and is taken for only two weeks, it may encourage more treatment of the debilitating condition.The Food and Drug Administration on Friday approved the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States every year.Clinical trial data show the pill works quickly, beginning to ease depression in as little as three days, significantly faster than general antidepressants, which can take two weeks or longer to have an effect. That — along with the fact that it is taken for just two weeks, not for months — may encourage more patients to accept treatment, maternal mental health experts said.The most significant aspect of the approval may not be the features of the drug, but that it is explicitly designated for postpartum depression. Several doctors and other experts said that while there were other antidepressants that are effective in treating the condition, the availability of one specifically shown to address it could help reduce the stigma of postpartum depression by underscoring that it has biological underpinnings and is not something women should blame themselves for.The hope is that it will encourage more women to seek help and prompt more obstetricians and family doctors to screen for symptoms and suggest counseling or treatment.“This is a patient population that just so often falls through the cracks,” said Dr. Ruta Nunacs, a psychiatrist with the Center for Women’s Mental Health at Massachusetts General Hospital. “When women are told, ‘You have postpartum depression,’ it’s embarrassing, it is demeaning, it makes them feel like a bad mom.”She added, “There’s also a lot of stigma about taking antidepressant medication, so that might make this treatment more appealing because it’s really a treatment specific for postpartum depression.”An estimated 10 to 15 percent of women who give birth in the United States experience depression during pregnancy or in the year afterward. The condition can be accompanied by intense anxiety, shame, guilt, impaired sleep, panic attacks and suicidal thoughts or attempts. And it can make it difficult for mothers to provide their babies with the care, bonding and nurturing that is crucial for healthy development.“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany R. Farchione, the director of the F.D.A. division responsible for the approval, said in a statement.The pill, zuranolone, which will be marketed under the brand name Zurzuvae, was developed by Sage Therapeutics, a Massachusetts company that produces it in partnership with Biogen. It is expected to be available after the Drug Enforcement Administration completes a 90-day review required for drugs affecting the central nervous system, Sage said. The companies have not announced a price for the pill.The only other drug approved for postpartum depression is brexanolone, also developed by Sage and marketed as Zulresso. But brexanolone, approved in 2019, requires a 60-hour intravenous infusion in a hospital, carries risks of loss of consciousness and costs $34,000. Sage says only about 1,000 patients have received it so far.Taking a pill for two weeks is much easier, not requiring a mother to leave her baby for several days. However, the F.D.A. did require the label to include warnings about possible suicidal thoughts and behavior, sleepiness and confusion. The label will also include a so-called “black box warning” that patients should not drive or operate heavy machinery for at least 12 hours after taking the pill. The pill should be taken in the evening “with a fatty meal,” the agency’s announcement said. Doctors said Zurzuvae would not be appropriate for everyone experiencing postpartum depression. For those with mild to moderate depression, talk therapy can work well. Dr. Kimberly Yonkers, chairwoman of the psychiatry department at University of Massachusetts Chan Medical School, said she would probably not recommend Zurzuvae for patients with longstanding recurrent depression or for “somebody who has a severe episode with a suicidal attempt or hospitalization because you don’t give them a treatment for two weeks and then stop it.”Appropriate patients, she said, might include “people who have not had a complete response to another antidepressant.”Dr. Alison Reminick, director of the women’s reproductive mental health program at the University of California, San Diego, said about 10 percent of her patients would be likely candidates. Those would include women experiencing depression for the first time. Such patients are at higher risk of developing bipolar disorder, she said. Although drugs such as Lexapro, Zoloft and other selective serotonin reuptake inhibitors (S.S.R.I.s) work, they can cause mania in those patients, she said.She would also offer Zurzuvae to women whose depression was accompanied by anxiety or insomnia because studies suggest it may ease those symptoms.“I’m a huge fan of S.S.R.I.s,” Dr. Reminick said, but noted that many patients resisted trying medication. “I think this will be much easier to get them to just try this for two weeks.”Data submitted to the F.D.A. came from two company-funded clinical trials involving about 350 patients. A majority of those receiving Zurzuvae (72 percent in one trial, 57 percent in another) clinically responded to the treatment after the two-week course, meaning that their scores on a standard depression scale improved by 50 percent or more.Depression also improved in women receiving the placebo, a common phenomenon in studies of depression treatments, possibly because interacting with medical teams in a trial is itself helpful. But in the group receiving Zurzuvae, the improvement was consistently greater, by several points, beginning three days after starting the medication. Fifteen days after taking the first pill, Zurzuvae patients were significantly more likely to have a low enough depression score to be considered in remission.The effect continued after the patients stopped taking the medicine, throughout the 45 days that they were monitored in the trials. But several maternal mental health experts said longer-term data was needed to determine if patients relapse.The main side effects of Zurzuvae were sleepiness and dizziness. Importantly, the trials found no evidence of increased suicidality or withdrawal symptoms after patients stopped taking the drug.Amy Bingham, 33, of Gibsonville, N.C., received Zurzuvae in a clinical trial in 2018, about six months after giving birth to her son Benjamin.“I did start to feel calmer — I wasn’t having as many days where I was feeling as tearful,” said Ms. Bingham. Eventually, “I felt that I could enjoy my time with my son.”Kate Medley for The New York TimesMs. Bingham, who works from home for a call center, had experienced depression as a teenager, but her postpartum depression symptoms were different, including panic attacks, tears and shortness of breath.“I was very anxious that I would do something wrong, that Ben would get hurt because of a mistake I would make,” she said, “that I wasn’t able to respond to his needs effectively and that because I wasn’t able to, he would be an unhappy baby.”Sometimes, she said, “I would think I was a terrible mother because I couldn’t soothe my own child.”Her depression scores recorded in the trial improved by the third day on the medicine and reached remission levels by Day 15, according to data shared with The New York Times.Under standard procedure in such trials, Ms. Bingham did not know if the pill she took for two weeks was Zurzuvae or placebo. She said: “I didn’t feel a lot of improvement at first. It did take about a month for me to start feeling some of the benefits.”But gradually, she said, “I did start to feel calmer.”“I wasn’t having as many days where I was feeling as tearful,” she continued. Eventually, “I felt that I could enjoy my time with my son.”Zurzuvae contains a synthetic version of a neurosteroid or brain hormone called allopregnanolone, which is produced by progesterone and helps regulate a mood-related neurotransmitter, said Dr. Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill and a lead investigator for the trials of Zurzuvae for postpartum depression.During pregnancy, “levels of estrogen and progesterone rise many-fold and then they fall precipitously at the time of childbirth,” she said. She added that, for genetic or other reasons, women who develop postpartum depression seem especially sensitive to that surge and drop-off, which also lowers allopregnanolone levels.Typically, “increases in allopregnanolone help deal with acute stress,” said Amy VandenBerg, a psychiatric pharmacist at the University of Michigan. Zurzuvae might address postpartum depression by essentially replenishing depleted allopregnanolone and targeting the same neurotransmitters to stabilize mood, she said.Although many cases of maternal depression begin in pregnancy, the pill is not being recommended until after childbirth because it operates on a hormonal pathway and wasn’t tested in pregnant women, Dr. Meltzer-Brody said. The warning label says the drug could cause harm to a fetus.The pill was not tested in women who were breastfeeding their babies. Several doctors said they would inform patients who were considering taking it that there was little data about the drug’s effect on lactating. Some women might be able to pump milk for the two weeks they plan to take Zurzuvae and resume nursing afterward. Some S.S.R.I.s and other antidepressants have been found to be safe for breastfeeding.About 15 to 20 percent of women in the trials continued taking other antidepressants they had been on for a while. Experts said it was possible that for some patients Zurzuvae would be an adjunct medication or would be used as a bridge to longer-term antidepressants.“It’s not the only treatment that’s helpful for postpartum depression, but the innovation and the excitement about this is that it’s specific, designed to target postpartum depression based on potential biological causes,” said Wendy Davis, executive director of Postpartum Support International, a nonprofit that raises awareness and provides resources for those experiencing maternal mental health issues. “It gives the understanding that there is a biological reason for what you’re feeling right now,” she said, adding “It is not your fault.”The fact that there’s a medication prescribed for a mother’s depression might prompt family members to “give recognition to it and increase how much help they give mom,” Dr. Reminick said.“If it gets more people into treatment, that’s wonderful,” Dr. Nunacs said. “If it doesn’t work, they’re connected with providers and we can try other things. So it opens a door for treatment that has been hard to open in the past.”

The price of the pill, which has not been announced, will determine how affordable it will be when it becomes available in early 2024.The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.Since the Supreme Court overturned the national right to an abortion last year, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.In a survey last year by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience. Nearly 40 percent said they would be likely to use it. Those most likely to opt for the product included women already taking birth control pills, women without health insurance and Hispanic women, the survey found.And strikingly, at a time of fierce divisions over abortion, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to come primarily from some Catholic organizations and Students for Life Action.In May, a panel of 17 independent scientific advisers to the F.D.A. — including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription vastly outweighed the risks. The panel cited the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93 percent effective at preventing pregnancy with typical use. Several panelists said there was a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.“The evidence demonstrates that the benefits clearly exceed the risks,” said one advisory committee member, Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health. She added: “I think Opill has the potential to have a huge positive public health impact.”For proponents of over-the-counter pills, the main issue is affordability.The Affordable Care Act requires heath insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating coverage of over-the-counter birth control, but most states do not. The KFF survey found that 10 percent of women would not be able or willing to pay any out-of-pocket cost for contraception. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.Under a recent executive order by President Biden, the federal government could soon take steps toward requiring insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced legislation to require such coverage.“We need to make it affordable and available,” Senator Patty Murray, a Democrat from Washington State and a co-sponsor of the bill, said in an interview in May. “Let’s provide women what they need and make sure it’s affordable so there’s equity, and women who are low-income, women who for whatever reason are struggling don’t have to be forced to not have any birth control simply because they can’t afford it today,” she added.Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.The F.D.A. analysts who evaluated the data Perrigo submitted in its application for a nonprescription Opill had raised concerns about whether women with medical conditions that should preclude them from taking birth control pills — primarily breast cancer and undiagnosed vaginal bleeding — would follow the warnings and avoid the product. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.Several advisory committee members said patients with breast cancer, the main medical condition that precludes taking hormonal contraception, typically have doctors who would advise them to avoid birth control pills. They also said that Opill might actually be safest for adolescents because they are very unlikely to have breast cancer. And because young people often start off with contraception they can buy over-the-counter, it is especially important for them to have easy access to a method more effective than condoms and other birth control products available in retail stores, the panelists said. Perrigo reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps, such as abstaining from sex or using a condom, Dr. Stephanie Sober, the company’s U.S. medical liaison, said at the advisory committee hearing. She said that among 955 participants, only six became pregnant while using Opill.Most people who said they had missed doses attributed that to running out of pills before they could get to one of the study’s resupply sites, results that, Dr. Sober said, “illustrate precisely the barriers to adherence that could be lessened” by making the pill available over the counter.

The F.D.A. gave full approval to the drug, but added a black-box warning about safety risks. Medicare said it would cover most of the high cost.The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks.The F.D.A.’s decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit. But the agency also added a so-called black-box warning — the most urgent level — on the drug’s label, stating that in rare cases the drug can cause “serious and life-threatening events” and that there have been cases of brain bleeding, “some of which have been fatal.”Leqembi cannot repair cognitive damage, reverse the course of the disease or stop it from getting worse. But data from a large clinical trial suggests that the drug — administered every two weeks as an intravenous infusion — may slow decline by about five months over about 18 months for people with mild symptoms.Still, some Alzheimer’s experts have said it is unclear from the medical evidence whether Leqembi’s ability to delay erosion of memory and cognition would be enough to be noticeable or meaningful for patients and their families. And while most cases of brain swelling and bleeding have been mild or moderate and have resolved, there have been some serious cases.“The risks are very vivid,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, who said he will prescribe Leqembi after carefully evaluating patients and explaining the potential pros and cons. “Within the first few months, you may have small bleeds or swelling in your brain, which may or may not be symptomatic and if not detected in time can cause disability.”“In contrast,” Dr. Karlawish continued, “the benefits of slowing are subtle. You’re not going to experience the perception of changes in your cognition or function in the same amount of time.”Though Medicare will cover 80 percent of Leqembi’s $26,500 cost, patients could still shoulder thousands of dollars in co-payments.Eisai, a Japanese pharmaceutical company, led the development and testing of Leqembi (pronounced le-KEM-bee). Eisai is partnering and splitting profits with the American company Biogen, the maker of the controversial Alzheimer’s drug Aduhelm, for its commercialization and marketing.The F.D.A.’s approval of Aduhelm was severely criticized because the evidence of potential benefit was inconclusive, with one trial showing modest slowing of decline but another showing no slowing. Before that approval, a committee of independent advisers and an F.D.A. council of senior officials said there was not enough evidence that it worked. Many medical centers declined to prescribe Aduhelm, and Medicare has covered it only for clinical trial participants, sharply restricting its availability.Evidence supporting Leqembi is much clearer, Alzheimer’s experts said.Leqembi will be available for people with mild dementia or a pre-Alzheimer’s condition called mild cognitive impairment. The F.D.A. label instructs doctors not to treat patients without testing to confirm they have an accumulation of the protein amyloid, a hallmark of Alzheimer’s that Leqembi attacks.About 1.5 million people in the United States are estimated to be in the beginning phases of Alzheimer’s. Many more — about five million — have progressed too far to be eligible for Leqembi. Alex Scott, Eisai’s executive vice president of integrity, said the company recommends patients stop using Leqembi once they develop moderate Alzheimer’s disease.Alzheimer’s experts said they would inform some patients that they had greater risk for brain swelling and bleeding — including those taking blood thinners, those with more than four microscopic bleeds in the brain and those with an Alzheimer’s-linked gene mutation called APOE4.The risk to people with two copies of the APOE4 mutation — about 15 percent of people with Alzheimer’s — is so high that the F.D.A.’s black-box warning recommends that all patients be genetically tested to assess their safety risk and spells out that those with two APOE4 copies are more vulnerable to developing “symptomatic, serious and severe” brain bleeding or swelling.The black-box warning will apply to all drugs that, like Leqembi, are monoclonal antibodies that attack amyloid. Leqembi is the first to get full approval, but others are in various stages of development.The warning does not mention patients who are taking blood thinners, but Leqembi’s label says that “additional caution should be exercised” when considering whether to give blood thinners to Leqembi patients. The F.D.A. greenlighted Aduhelm under a program called “accelerated approval,” which can be given to drugs with uncertain benefit under specific criteria, including that the company conduct another clinical trial. Leqembi received accelerated approval in January, but that status meant Medicare would only cover the drug in limited circumstances.The F.D.A. decision granting full approval to Leqembi means that Medicare will cover it for eligible patients.Still, some patients will be unable to afford the 20 percent Medicare does not cover, possibly about $6,600 a year. Including costs of medical visits and required regular brain scans, some of which will receive Medicare reimbursement, the treatment could run to about $90,000 a year, some experts estimate.A recent study estimated that covering the drug and necessary services for about 85,000 patients would cost Medicare $2 billion a year and would climb to $5.1 billion if the number of patients reached about 216,000. That could lead to an increase in premiums for all Medicare beneficiaries, not just those receiving Leqembi, the study said.In interviews, Ivan Cheung, the chairman and chief executive of Eisai’s United States operations, estimated that in the first three years, about 100,000 patients would be receiving the drug.The Medicare agency is adding a requirement that doctors prescribing Leqembi submit medical information about each patient before and while they are being treated with the drug. The information will be kept in patient registries and evaluated to learn more about Leqembi’s benefits or harms, the agency said.“With F.D.A.’s decision, C.M.S. will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” the administrator of the Centers for Medicare and Medicaid Services, Chiquita Brooks-LaSure, said in a statement.Some advocacy groups, like the Alzheimer’s Association, have criticized the registry requirement, calling it an unnecessary barrier to access. But medical experts say registry programs are common and easy to comply with. Their concern is that the registry won’t be comparing Leqembi patients with others, so it won’t be able to say if Leqembi slows cognitive decline.The F.D.A.’s approval on Thursday was based on a large trial indicating that patients receiving Leqembi declined 27 percent more slowly over 18 months than patients receiving a placebo. The difference between those receiving drug and placebo was small — less than half a point, on an 18-point cognitive scale that assesses functions like memory and problem-solving. Some Alzheimer’s experts say that for slowing of decline to be clinically meaningful, or noticeable to patients and families, the difference between the groups must be at least one point.Leqembi patients also declined more slowly on three secondary measures of cognition and daily function, and data on biological markers was generally stronger for Leqembi than for the placebo. All these measures moving in the same direction strengthens the idea that the drug can benefit patients, experts say.Still, a report on the data, published in The New England Journal of Medicine and co-written by scientists from Eisai, concluded that “longer trials are warranted to determine the efficacy and safety.”Concerns about safety have been stoked by reports of deaths of three clinical trial participants who experienced brain swelling and brain bleeding, two of whom were being treated with blood thinners. Eisai has said it is unclear if Leqembi contributed to their deaths because the patients had complex medical issues.“You’ve got small benefits and a certain risk for serious adverse events, and that has to be balanced,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who said he will prescribe Leqembi to carefully evaluated patients.“If its efficacy were greater, we would not be talking about adverse events as much because we would see a clear benefit,” he said, adding, “I think many people will see this and say it’s not worth the effort, it’s not worth twice-a-month infusions.”Dr. Karlawish said the decisions facing patients and families will be complicated. Because eligible patients have only mild symptoms of cognitive decline, some might opt to take any medication that might prolong that relatively functional stage, while others might only consider the risks of the drug worthwhile if they were much more impaired.Dr. Karlawish said one recent patient declined to get evaluated for potential treatment, indicating that “‘I want more benefits, I don’t see the value.’” But, he said, “I have other patients, though, who would say, You mean you can give me a drug that could slow the disease?”In the trial, nearly 13 percent of patients receiving Leqembi experienced brain swelling, which was mostly mild or moderate, while less than 2 percent of patients receiving the placebo experienced such swelling. Most brain swelling did not cause any symptoms, generally emerged soon after use began and resolved within a few months. About 17 percent of Leqembi patients experienced brain bleeding, compared with 9 percent of patients receiving a placebo. The most common symptom from brain bleeds was dizziness.Overall, the results suggest the risk of brain bleeding and swelling was significantly lower than for patients in trials of Aduhelm.Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who studies medication regulation and use, said doctors will feel pressure to prescribe Leqembi from patients, families and advocacy organizations. Medical institutions will also have an “enormous financial incentive” because of the Medicare reimbursement that “they could then spend on social workers and all the other things that Medicare will not reimburse,” he said, adding “any economically self-respecting memory center is going to see this as an economic windfall.”

Medicare will cover much of the cost for patients in the early stages of the disease, but Leqembi has safety risks and can only modestly slow cognitive decline.On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the cost of the $26,500-per-year medication. The decisions by the two federal agencies will vastly increase access to the drug but also present a dilemma for patients and their families.There are many factors, both financial and medical, to weigh. Here are answers to some crucial questions:How well does the drug work?Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. It also does not stop the disease from getting worse. What Leqembi can do is modestly slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow decline by about five months over a period of 18 months for those patients.How the drug might affect a patient’s daily life is likely to vary widely. For some people, Leqembi might mean several additional months of being able to follow a recipe, balance a checkbook or accomplish other activities without help. For others, the impact might be much more subtle and barely noticeable.Are there risks from taking it?Yes. The drug can cause swelling or bleeding in the brain that is often mild or moderate and resolves on its own but can be serious and in very rare cases can be fatal. The F.D.A. was so concerned about these side effects that it is requiring a “black-box warning” — the most urgent level — on the drug’s label, saying that the medication can cause “serious and life-threatening events.”Patients who are at higher risk include those on blood thinners, those who have had more than four microscopic bleeds in the brain and those with an Alzheimer’s-linked gene mutation called APOE4 — especially if they have two copies of the mutation. They, along with their doctors, should consider whether the increased safety risk outweighs their desire for a medication that might modestly slow cognitive decline.A large clinical trial of the drug found that nearly 13 percent of patients receiving Leqembi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients receiving the placebo experienced such swelling. Most brain swelling did not cause any symptoms and generally resolved within a few months.About 17 percent of the patients receiving Leqembi experienced brain bleeding, compared with 9 percent of patients receiving the placebo. The most common symptom from brain bleeds was dizziness, the study said.Who is eligible to take Leqembi?Leqembi — which is administered by intravenous infusions in a doctor’s office or clinic every two weeks — will be available for people diagnosed as having early-stage Alzheimer’s and for those with a pre-Alzheimer’s condition called mild cognitive impairment. About 1.5 million people in the United States fit that description. An additional 5 million who have Alzheimer’s will not qualify for Leqembi because their disease has progressed too far.The F.D.A.-required label on the drug instructs doctors not to treat patients without testing to confirm that they have one of the hallmarks of Alzheimer’s: a buildup in the brain of the protein amyloid, which Leqembi attacks. Amyloid levels can be assessed with PET scans, spinal taps or newly available blood tests.How much will we have to pay?Most patients will be old enough for Medicare, which has said it will pay for 80 percent of the $26,500 annual cost of the drug. Patients would be left with about $6,600 in co-payments, which may put the drug out of financial reach for many. Some or all of that co-payment might be covered by the supplemental private insurance policies that many Medicare patients have.There are potentially tens of thousands of dollars of additional costs, however — including medical visits for the infusions and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Leqembi could run to about $90,000 a year. With 80 percent coverage, treatment could potentially leave patients saddled with $18,000 per year in out-of-pocket costs.How should people and their families decide?Talk to your doctor. If your doctor is not well-versed in Alzheimer’s treatments, consider talking with a specialist. The most important thing is to discuss the decision with medical experts who will carefully explain the risks for your specific situation.To learn those risks, ask for genetic testing to determine if you have the APOE4 gene mutation. People with two copies of that mutation — about 15 percent of Alzheimer’s patients — are at especially high risk of brain swelling and bleeding.There are other factors to consider too. Would going to a clinic for a drug infusion every two weeks pose a burden?And, importantly, how do you and your family perceive your current cognitive condition and how it affects your life? Because Leqembi is for people with mild symptoms, some people might be less inclined to take safety risks, but others might consider it especially important to try a drug that might keep them at this mild stage a bit longer.