FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

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By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food and Drug Administration announced Monday.

U.S. health officials said they will remove the boxed warning from more than 20 pills, patches and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats.

The change has been supported by some doctors — including FDA Commissioner Marty Makary, who has called the current label outdated and unnecessary.

The labeling change reflects a “more nuanced, evidence-based communication of hormone therapy risks,” Makary and other FDA officials wrote in a commentary published Monday in the Journal of the American Medical Association.

FDA officials justified the new label by pointing to studies suggesting hormone-therapy has few risks when started before age 60 or within 10 years of menopause symptoms.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” Health Secretary Robert F. Kennedy Jr. said introducing the change.

The long-standing FDA warning advised doctors that hormone therapy can increase the risk of blood clots, heart problems and other health issues, citing data published more than 20 years ago.

Many doctors — and pharmaceutical companies — have called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit.

But other experts have vigorously opposed making changes to the label without a careful, transparent process. They say the FDA should have convened its independent advisers to publicly consider any revisions.

Current medical guidelines generally recommend the drugs for a limited duration in younger women going through early or mid-stage menopause who don’t have complicating risks, such as breast cancer or heart problems. FDA’s updated prescribing information mostly matches that approach.

But Makary and some other doctors have suggested that hormone therapy’s benefits can go far beyond managing uncomfortable mid-life symptoms. Before becoming FDA commissioner, Makary dedicated the first chapter of his most recent book to extolling the overall benefits of hormone therapy and criticizing doctors unwilling to prescribe it.

In Monday’s commentary he reiterated that viewpoint, citing figures suggesting hormone-therapy may help reduce heart disease, bone fractures and Alzheimer’s.

“With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy,” Makary wrote.

The veracity of those benefits and whether they outweigh the drugs’ risks remains the subject of intense debate. Experts — including those whose research led to the original warning — have disputed overall health claims for the drugs.

In the 1990s, millions of U.S. women took estrogen alone or in combination with progestin on the assumption that — in addition to treating menopause — it would reduce rates of heart disease, dementia and other issues.

But a landmark study of more than 26,000 women upended that idea, linking two different types of hormone pills to higher rates of stroke, blood clots, breast cancer and other serious risks. After the initial findings were published in 2002, prescriptions plummeted among women of all age groups, including those in earlier stages of menopause.

Since then, all estrogen drugs have carried the FDA’s boxed warning — the most serious type. National health data shows prescribing of the drugs has not increased over the last 20 years.

But continuing analysis has shown a more nuanced picture of the risks.

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A new analysis of the 2002 data published in September found that women in their 50s taking estrogen-based drugs faced no increased risk of heart problems, whereas women in their 70s did. The data was unclear for women in their 60s, and the authors advised caution.

Additionally, many newer forms of the drugs have been introduced since the early 2000s, including vaginal creams, rings and tablets which deliver lower hormone doses than pills, patches and other drugs that circulate throughout the bloodstream. Those products will receive their own label, reflecting their unique risks and benefits, the agency said.

The original language contained in the boxed warning will still be available to prescribers, but it will appear lower down in the prescribing information. Additionally the label will retain a boxed warning that women who have not had a hysterectomy should receive a combination of estrogen-progestin due to risks of cancer in the lining of the uterus.

Hanging over Monday’s announcement is the way the agency laid the groundwork for the decision.

Rather than convening one of the agency’s standing advisory committees on women’s health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs.

Many of the panelists invited to the July meeting consult for drugmakers or prescribe the medications in their private practices. Some also had ties to a pharmaceutical-sponsored campaign called Unboxing Menopause, which lobbied the FDA to remove the warning.

Nearly 80 researchers later sent a letter to the FDA calling for an official advisory committee meeting.

Diana Zuckerman of the nonprofit National Center for Health Research, which analyzes medical research, accused Makary of undermining the FDA’s credibility by announcing the change “rather than having scientists scrutinize the research at an FDA scientific meeting.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

The highest and lowest PFF grades from the Vikings’ loss to the Ravens

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Everybody loves player grades courtesy of Pro Football Focus, right?

Though it’s become commonplace for some people in NFL circles to criticize Pro Football Focus for its process, the player grades offer some easily digestible insight into who played well and who played poorly in a game.

Here’s a look at the player grades from the Vikings’ 27-19 loss to the Baltimore Ravens:

Top 3 on offense (minimum 20 snaps)

Jalen Nailor … 87.5

Brian O’Neill … 66.2

Christian Darrisaw … 65.5

Analysis: This makes sense for Nailor considering he had a breakout game with five catches for 124 yards and a touchdown. Though it might seem surprising that O’Neill scored as well as he did considering he had three false start penalties, he held up well in pass protection, and was a big part of establishing the run. The same goes for Darrisaw on the other side of the offensive line.

Bottom 3 on offense (minimum 20 snaps)

T.J. Hockenson … 46.5

Blake Brandel … 53.3

J.J. McCarthy … 53.4

Analysis: The lack of production from Hockenson is starting to become a concerning trend. He only logged two catches in the game. Some of the falls on Hockenson for not making himself more available. Some of that falls on the shoulders on the McCarthy for not finding him underneath. The latter is a part of a bigger issue as McCarthy’s inaccuracy has significantly hindered the offense as a whole.

Top 3 on defense (minimum 20 snaps)

Jalen Redmond … 74.5

Dallas Turner … 71.0

Javon Hargrave … 69.8

Analysis: It was another impressive performance from Redmond as he continues to establish himself as a force in the trenches. He finished with eight combine tackles in the game. That effort from Redmond was instrumental in slowing down running back Derrick Henry. As for Turner, he made the most of his 27 snaps, and likely would have scored even higher had his sack not be nullified due to a roughing the passer penalty.

Bottom 3 on defense (minimum 20 snaps)

Jonathan Greenard … 36.2

Josh Metellus … 37.2

Harrison Smith … 38.1

Analysis: The impact of Greenard was felt in his absence as the defense slowly waned in its ability to stop the run. That said, Greenard got docked points even before he left the game with a shoulder injury, namely because of his tackling at the point of attack. Meanwhile, Metellus was deemed to have struggled in coverage, while Smith was deemed to have struggled in tackling, as well.

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Supreme Court will decide whether states can count late-arriving mail ballots, a Trump target

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By MARK SHERMAN

WASHINGTON (AP) — The Supreme Court on Monday agreed to decide whether states can continue to count late-arriving mail ballots, which have been a target of President Donald Trump.

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The justices took up an appeal from Mississippi after a panel of three judges nominated by the Republican president on the 5th U.S. Circuit Court of Appeals ruled last year that the state law allowing ballots that arrive shortly after Election Day to be counted violated federal law.

Mississippi is among 18 states and the District of Columbia that accept mailed ballots received after Election Day as long as the ballots are postmarked on or before that date, according to the National Conference of State Legislatures.

The list includes swing states such as Nevada and states such as Colorado, Oregon and Utah that rely heavily on mail voting.

An additional 14 states allow the counting of late-arriving ballots from some eligible voters, including overseas U.S. service members and their families, according to a filing from Democratic-led states that urged the justices to reverse the appellate ruling.

The case will be argued in the late winter or early spring. A final ruling almost certainly will come by late June, early enough to govern the counting of ballots in the 2026 midterm congressional elections.

Mississippi Attorney General Lynn Fitch, a Republican, told the Supreme Court that the appellate ruling “will have destabilizing nationwide ramifications” if left in place.

“The stakes are high: ballots cast by — but received after — election day can swing close races and change the course of the country,” Fitch wrote.

Trump has claimed that late-arriving ballots and drawn-out electoral counts undermine confidence in elections. In March, the Republican president signed an executive order on elections that aims to require votes to be “cast and received” by Election Day. The order has been challenged in court.

The Republican National Committee and the Libertarian Party of Mississippi led the challenge to the Mississippi law. A federal judge dismissed a similar challenge to Nevada’s law, but the decision has been appealed.

The Supreme Court is separately considering reviving a lawsuit filed by Rep. Mike Bost, R-Ill., and backed by the Trump administration that challenges Illinois’ ballot receipt law. The issue is whether the congressman has the legal right to sue.

Some Republican-led states, including Kansas and North Dakota, have taken steps to stop counting late-arriving ballots. In Ohio, Republican lawmakers are advancing legislation that would require ballots to be received by Election Day, closing the window for mailed ballots. The measure has passed the state Senate.

In the Mississippi case, Judge Andrew Oldham wrote for the appellate panel that Congress established a “singular” Election Day for members of Congress and presidential electors, “by which ballots must be both cast by voters and received by state officials.” Judges James Ho and Stuart Kyle Duncan joined Oldham’s opinion invalidating the Mississippi law.

The ruling reversed a decision by U.S. District Judge Louis Guirola Jr., who had held that there was no conflict between the state and federal laws. “All that occurs after election day is the delivery and counting of ballots cast on or before election day,” wrote Guirola, who was nominated by President George W. Bush, a Republican.

Nvidia and other tech stocks help Wall Street recover much of last week’s losses

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By STAN CHOE, AP Business Writer

NEW YORK (AP) — Big Tech and other superstars of the U.S. stock market are rallying on Monday, as Wall Street recovers much of its loss from last week.

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The S&P 500 climbed 1.2% to claw back more than two-thirds of its first weekly loss in the last four. The Dow Jones Industrial Average was up 183 points, or 0.4%, as of 10:15 a.m. Eastern time, and the Nasdaq composite was 1.9% higher.

Nvidia was by far the strongest force pushing the market upward and rose 4%. It and other winners in the frenzy around artificial-intelligence technology had been at the center of last week’s drop. Critics say their stock prices shot too high and too fast in the mania around AI, drawing comparisons to the 2000 dot-com bubble that ultimately burst.

Taiwan Semiconductor Manufacturing Co., which makes chips for Nvidia and other companies, saw its stock that trades in United States rise 3.1% after saying its revenue climbed nearly 17% in October from a year earlier. While such growth is strong compared with other companies, it’s a slowdown from TSMC’s earlier performance.

Another AI darling, Palantir Technologies, jumped 8% for the biggest gain in the S&P 500.

The gains for tech helped offset losses across much of the rest of the market, as the majority of stocks within the S&P 500 index sank.

Health insurers fell as uncertainty remains about whether Washington will extend expiring health care tax credits, a sticking point in the disagreement on Capitol Hill that’s created the longest-ever shutdown for the U.S. government.

That’s even though the Senate took the first steps on Sunday to end the shutdown.

President Donald Trump suggested in a social media post over the weekend — with few details — that the subsidies being sent to the “money sucking” insurance companies should instead be sent directly to people so they can buy their own health insurance.

Humana fell 2.6%, and Cigna slipped 0.7%.

The effects of the government’s shutdown have become more apparent following the cancellations of thousands of flights over the weekend. Towers are facing shortages as some air traffic controllers — unpaid for weeks — have stopped showing up for work.

Besides the pain at airports, the U.S. government’s shutdown has also delayed many important reports on the economy. A resumption could upset financial markets if the released logjam shows data that dashes traders’ expectations for coming cuts to interest rates.

The wide expectation is that the Federal Reserve will continue to cut its main interest rate in hopes of shoring up what has been a slowing job market. Wall Street loves lower interest rates because they can give the economy a boost while also pushing prices for investments upwards.

But the Fed has said it may have to halt its cuts if inflation worsens because lower interest rates can give inflation more fuel.

Without updates from the U.S. government on jobs and the economy, traders have been trawling profit reports from companies for clues about how things are going.

Tyson Foods, which sells chicken and other meat, climbed 2.1% after reporting a stronger profit for the latest quarter than analysts expected. It benefited from increases in prices of 11% to 17% for its beef and pork.

Roughly four out of every five companies in the S&P 500 have also been reporting stronger profits for the summer than analysts expected. Companies usually top analysts’ profit expectations each quarter, but the pressure was high this time around because they needed to justify the big moves upward their stock prices have made since April.

Delivering bigger profits is one of the easier ways they can quiet criticism that their stock prices have become too expensive.

Companies have also been giving generally strong forecasts for upcoming results, according to Bank of America strategist Savita Subramanian. That has analysts’ overall expectations for earnings in 2026 nearly all the way back to where they were before Trump shocked the economy and financial markets with his “Liberation Day” announcement of worldwide tariffs.

In stock markets abroad, indexes rallied across much of Europe and Asia.

South Korea’s Kospi jumped 3% for one of the bigger gains. Chip company SK Hynix, which is cooperating with Nvidia on artificial intelligence, leaped 4.5%. Its bigger rival, Samsung Electronics, climbed 2.8%.

In the bond market, the yield on the 10-year Treasury edged down to 4.10% from 4.11% late Friday.

AP Business Writers Matt Ott and Elaine Kurtenbach contributed.