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Q&A: The FDA says the abortion pill mifepristone is safe. Here's the evidence

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Q&A: The FDA says the abortion pill mifepristone is safe. Here's the evidence

Abortion is back on the docket at the U.S. Supreme Court, with the justices hearing arguments Tuesday about whether a pill used to terminate early pregnancies was properly evaluated by the Food and Drug Administration.

The medication, mifepristone, has been used in the United States more than 5 million times since it was approved for use in 2000, according to Danco Laboratories, the company that sells it under the brand name Mifeprex. Fewer than 0.5% of women who take it experience “serious adverse reactions,” and deaths are exceedingly rare, the FDA says in its prescribing information for doctors.

Mifepristone debuted in France, its home country, and China in 1988. It is now approved in 96 countries, from Albania to Zimbabwe, according to Gynuity Health Projects, a nonprofit that advocates for women’s reproductive rights.

Here’s a closer look at the safety of mifepristone.

What is mifepristone?

Mifepristone is the generic name of a pill that makes up half of the two-drug regimen used in medication abortions in the United States. When used in conjunction with a drug called misoprostol, it can terminate a pregnancy that is in the first 10 weeks of gestation.

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The synthetic steroid was originally known as RU-486 (the “RU” stands for Roussel-Uclaf, the French company that developed the pill). It is also sold under the brand name Mifeprex.

How does mifepristone work?

It prevents a natural steroid hormone called progesterone from doing its job, which is to get the inner lining of the uterus ready for an embryo to implant about a week or so after an egg is fertilized.

Mifepristone gets in the way of this process by blocking the receptors that progesterone would normally bind with.

How do we know it is safe?

As with other medications, the Food and Drug Administration has monitored mifepristone’s safety profile in the decades since it went on the market. If problems cropped up that weren’t evident during clinical trials, the agency could have revoked its approval.

Instead, it has expanded access to mifepristone. For example, it was initially approved for use during the first seven weeks of pregnancy; in 2016, that window was extended to 10 weeks. Likewise, after the COVID-19 pandemic accelerated acceptance of telemedicine, the FDA in 2021 stopped requiring patients to see a healthcare provider in person in order to get a mifepristone prescription.

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Those two decisions are at issue in the cases going before the court Tuesday.

“Hundreds of medical studies and vast amounts of data have confirmed its safety and efficacy as part of this two-drug regimen,” the American College of Obstetricians & Gynecologists, the American Medical Assn., and other medical societies wrote in a friend-of-the court brief filed on behalf of the FDA and Danco. The brief noted that “major adverse events occur in less than 0.32% of patients” and that “the risk of death is almost non-existent.”

Another sign of the drug’s safety is the fact that medication abortions have overtaken surgical abortions in the United States. Last year, 63% of abortions nationwide were carried out with mifepristone, according to the Guttmacher Institute, a nonprofit research group that supports reproductive rights.

Are there side effects to taking mifepristone?

There can be. According to the FDA, the most common ones include headaches, weakness, dizziness, nausea, vomiting, diarrhea, fever and chills.

The serious side effects to watch out for after using both drugs in the regimen are heavy bleeding (which the FDA describes as “enough to soak through two thick full-size sanitary pads per hour for two consecutive hours”), abdominal pain, a fever above 100.4 degrees Fahrenheit that lasts for at least four hours, and “feeling sick” more than a day after taking misoprostol.

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Symptoms like these could be signs of a life-threatening infection, an ectopic pregnancy or another serious problem. Anyone experiencing them should contact a healthcare provider right away.

Can mifepristone be fatal?

The FDA says it is aware of 32 women who died after taking mifepristone between September 2000 (when it was first approved in the United States) and the end of 2022.

However, it’s not clear that mifepristone was responsible for any of these deaths. Two of them were definitely caused by ruptured ectopic pregnancies, several died of drug intoxication or overdoses, and at least two women who took the pill were victims of homicides, the FDA said. As for the remaining cases, patients were taking other medications or undergoing treatments at the same time, making it difficult to pin the blame on mifepristone, according to the agency.

In their legal brief, the medical groups said that in the worst-case scenario, the drug could have caused no more than 13 of the 32 deaths. That makes the drug less dangerous than using “Viagra or getting one’s wisdom teeth removed.”

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What’s in a Name? For These Snails, Legal Protection

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What’s in a Name? For These Snails, Legal Protection

The sun had barely risen over the Pacific Ocean when a small motorboat carrying a team of Indigenous artisans and Mexican biologists dropped anchor in a rocky cove near Bahías de Huatulco.

Mauro Habacuc Avendaño Luis, one of the craftsmen, was the first to wade to shore. With an agility belying his age, he struck out over the boulders exposed by low tide. Crouching on a slippery ledge pounded by surf, he reached inside a crevice between two rocks. There, lodged among the urchins, was a snail with a knobby gray shell the size of a walnut. The sight might not dazzle tourists who travel here to see humpback whales, but for Mr. Avendaño, 85, these drab little mollusks represent a way of life.

Marine snails in the genus Plicopurpura are sacred to the Mixtec people of Pinotepa de Don Luis, a small town in southwestern Oaxaca. Men like Mr. Avendaño have been sustainably “milking” them for radiant purple dye for at least 1,500 years. The color suffuses Mixtec textiles and spiritual beliefs. Called tixinda, it symbolizes fertility and death, as well as mythic ties between lunar cycles, women and the sea.

The future of these traditions — and the fate of the snails — are uncertain. The mollusks are subject to intense poaching pressure despite federal protections intended to protect them. Fishermen break them (and the other mollusks they eat) open and sell the meat to local restaurants. Tourists who comb the beaches pluck snails off the rocks and toss them aside.

A severe earthquake in 2020 thrust formerly submerged parts of their habitat above sea level, fatally tossing other mollusks in the snail’s food web to the air, and making once inaccessible places more available to poachers.

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Decades ago, dense clusters of snails the size of doorknobs were easy to find, according to Mr. Avendaño. “Full of snails,” he said, sweeping a calloused, violet-stained hand across the coves. Now, most of the snails he finds are small, just over an inch, and yield only a few milliliters of dye.

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Video: This Parrot Has No Beak, But Is at the Top of the Pecking Order

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Video: This Parrot Has No Beak, But Is at the Top of the Pecking Order

new video loaded: This Parrot Has No Beak, But Is at the Top of the Pecking Order

Bruce, a disabled kea parrot, is missing his top beak. The bird uses tools to keep himself healthy and developed a jousting technique that has made him the alpha male of his group.

By Meg Felling and Carl Zimmer

April 20, 2026

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Contributor: Focus on the real causes of the shortage in hormone treatments

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Contributor: Focus on the real causes of the shortage in hormone treatments

For months now, menopausal women across the U.S. have been unable to fill prescriptions for the estradiol patch, a long-established and safe hormone treatment. The news media has whipped up a frenzy over this scarcity, warning of a long-lasting nationwide shortage. The problem is real — but the explanations in the media coverage miss the mark. Real solutions depend on an accurate understanding of the causes.

Reporters, pharmaceutical companies and even some doctors have blamed women for causing the shortage, saying they were inspired by a “menopause moment” that has driven unprecedented demand. Such framing does a dangerous disservice to essential health advocacy.

In this narrative, there has been unprecedented demand, and it is explained in part by the Food and Drug Administration’s recent removal of the “black-box warning” from estradiol patches’ packaging. That inaccurate (and, quite frankly, terrifying) label had been required since a 2002 announcement overstated the link between certain menopause hormone treatments and breast cancer. Right-sizing and rewording the warning was long overdue. But the trouble with this narrative is that even after the black-box warning was removed, there has not been unprecedented demand.

Around 40% of menopausal women were prescribed hormone treatments in some form before the 2002 announcement. Use plummeted in its aftermath, dipping to less than 5% in 2020 and just 1.8% in 2024. According to the most recent data, the number has now settled back at the 5% mark. Unprecedented? Hardly. Modest at best.

Nor is estradiol a new or complex drug; the patch formulation has existed for decades, and generic versions are widely manufactured. There is no exotic ingredient, no rare supply chain dependency, no fluke that explains why women are suddenly being told their pharmacy is out of stock month after month.

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The story is far more an indictment of the broken insurance industry: market concentration, perverse incentives and the consequences of allowing insurance companies to own the pharmacy benefit managers that effectively control drug access for the majority of users. Three companies — CVS Caremark, Express Scripts and OptumRx — manage 79% of all prescription drug claims in the United States. Those companies are wholly owned subsidiaries of three insurance behemoths: CVS Health, Cigna and UnitedHealth Group, respectively. This means that the same corporation that sells you your insurance plan also decides which drugs get covered, at what price, and whether your pharmacy can stock them. This is called vertical integration. In another era, we might have called it a cartel. The resulting problems are not unique to hormone treatments; they have affected widely used medications including blood thinners, inhalers and antibiotics. When a low-cost generic such as estradiol — a medication with no blockbuster profit margins and no patent protection — runs into friction in this system, the friction is not random. It is structural. Every decision in that chain is filtered through the same corporate profit motive. And when the drug in question is an off-patent estradiol patch that has negligible profit margins because of generic competition but requires logistical investment to keep consistently in stock? The math on “how much does this company care about ensuring access” is not complicated.

Unfortunately, there is little financial incentive to ensure smooth, consistent access. There is, however, significant financial incentive to steer patients toward branded alternatives, or simply to let supply tighten — because the companies aren’t losing much profit if sales of that product dwindle. This is not a conspiracy theory: The Federal Trade Commission noted this dynamic in a report that documented how pharmacy benefit managers’ practices inflate costs, reduce competition and harm patient access, particularly for independent pharmacies and for generic drugs.

Any claim that the estradiol patch shortage is meaningfully caused by more women now demanding hormone treatments is a distraction. It is also misogyny, pure and simple, to imply that the solution to the shortage is for women’s health advocates to dial it down and for women to temper their expectations. The scarcity of estradiol patches is the outcome of a broken system refusing to provide adequate supply.

Meanwhile, there are a few strategies to cope.

  • Ask your prescriber about alternatives. Estradiol is available in multiple formulations, including gel, spray, cream, oral tablet, vaginal ring and weekly transdermal patch, which is a different product from the twice-weekly patch and may be more consistently available depending on manufacturer and region.
  • Consider an online pharmacy. Many are doing a good job locating and filling these prescriptions from outside the pharmacy benefit manager system.
  • Call ahead. Patch shortages are inconsistent across regions and distributors. A call to pharmacies in your area, or a broader geographic radius if you’re able, can locate stock that your regular pharmacy doesn’t have.
  • Consider a compounding pharmacy. These sources can sometimes meet needs when commercially manufactured products are inaccessible. The hormones used are the same FDA-regulated bulk ingredients.

Beyond those Band-Aid solutions, more Americans need to fight for systemic change. The FTC report exists because Congress asked for it and committed to legislation that will address at least some of the problems. The FDA took action to change the labeling on estrogen in the face of citizen and medical experts’ pressure; it should do more now to demand transparency from patch manufacturers.

Most importantly, it is on all of us to call out the cracks in the current system. Instead of repeating “there’s a patch shortage” or a “surge in demand,” say that a shockingly small minority of menopausal women still even get hormonal treatments prescribed at all, and three drug companies control the vast majority of claims in this country. Those are the real problems that need real solutions.

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Jennifer Weiss-Wolf, the executive director of the Birnbaum Women’s Leadership Center at New York University School of Law, is the author of the forthcoming book When in Menopause: A User’s Manual & Citizen’s Guide. Suzanne Gilberg, an obstetrician and gynecologist in Los Angeles, is the author of “Menopause Bootcamp.”

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