WATCH: RFK Jr. says: The Food and Drug Administration will remove long-standing warnings from hormone-based menopause medications

WASHINGTON — Hormone-based medications used to treat hot flashes and other menopausal 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.

Watch Kennedy and FDA officials speak in the player above.

U.S. health officials said they will remove the boxed warning on more than 20 pills, patches and creams that contain hormones such as estrogen and progestin, which are approved to relieve bothersome symptoms such as night sweats.

The change was supported by some doctors, including FDA Commissioner Marty McCurry, who called the current label outdated and unnecessary.

The classification change reflects “more accurate, evidence-based communication about the risks of hormone therapy,” McCary 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 that hormone therapy has few risks when started before age 60 or within 10 years of the onset of menopausal symptoms.

Health Secretary Robert F. Kennedy Jr. on introducing this change: “We challenge outdated thinking and recommit to evidence-based medicine that empowers rather than restricts.”

The US Food and Drug Administration (FDA) has long advised doctors that hormone therapy can increase the risk of blood clots, heart problems and other health problems, citing data published more than 20 years ago.

Many doctors — and drug companies — have called for the label to be removed or revised, which they say discourages prescriptions and scares away women who could benefit from it.

But other experts strongly opposed making changes to the label without a rigorous and transparent process. They say the FDA should have invited its independent advisers to publicly consider any reviews.

Current medical guidelines generally recommend limited use of the drugs for younger women who are going through early or middle menopause and do not have complicating risks, such as breast cancer or heart problems. Updated prescribing information issued by the Food and Drug Administration (FDA) is mostly consistent with this approach.

But McCary and some other doctors point out that the benefits of hormone therapy can go beyond just managing uncomfortable midlife symptoms. Before becoming FDA commissioner, McCary devoted the first chapter of his latest book to extolling the sweeping benefits of hormone therapy and criticizing doctors unwilling to prescribe it.

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

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

The validity of these benefits and whether they outweigh the risks of medications remains a matter of intense debate. Experts — including those whose research led to the original warning — have questioned the public health claims of these drugs.

In the 1990s, millions of American women took estrogen alone or in combination with a 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 conducted on more than 26,000 women turned this idea upside down, as it linked two different types of hormonal pills to higher rates of stroke, blood clots, breast cancer, and other serious risks. After initial results were published in 2002, prescriptions declined dramatically among women of all age groups, including those in the early stages of menopause.

Since then, all estrogen medications have carried an FDA warning, which is the most serious type. National health data show that drug prescribing has not increased over the past 20 years.

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

A new analysis of data from 2002, published in September, found that women in their 50s who took estrogen-containing medications did not face an increased risk of heart problems, while women in their 70s did. The data were not as clear for women in their 60s, and the authors advised caution.

In addition, many newer forms of medication have been introduced since the early 2000s, including vaginal creams, rings, and tablets that provide lower hormonal doses than pills, patches, and other medications that circulate in the bloodstream. These products will receive their own branding, reflecting their unique risks and benefits, the agency said.

The original language in the boxed warning will still be available to prescribers, but will appear at the bottom of the prescription information. In addition, the label will retain a square warning that women who have not had a hysterectomy should receive a combination of estrogen and progestin due to the risk of endometrial cancer.

Holding Monday’s announcement is how the agency laid the groundwork for the decision.

Instead of convening one of the agency’s standing advisory committees on women’s health or drug safety, McCary earlier this year convened dozens of doctors and researchers who overwhelmingly supported the health benefits of hormone replacement drugs.

Many of the committee members invited to the July meeting consult with drug makers or prescribe drugs in their own practices. Some also had ties to a drug-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 a formal advisory committee meeting.

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

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