Nov 20, 2025
3 min read
Hormone therapy drugs have had warning labels for years. Food and Drug Administration Commissioner Marty Macari spoke about why the agency removed them.
See: FDA Commissioner Raises Warning on Menopause Hormone Treatment
The Food and Drug Administration says it has a black box safety warning on all hormone treatments, drugs, pills, and other treatments that reduce withdrawal symptoms and signs.
Popular warnings said these treatments could increase the risks of cancer, dementia, heart attack and stroke.
"The FDA this day we promise to avoid the victim of the woman" when the fdrogen products are taken to unlock the darkest goods.
Makary told All Things Remembered it was time for change because women "were denied hormone replacement therapy or were never offered it, despite the enormous short- and long-term benefits."(See interview above.)
Instead of a black box warning on the label, the agencies would like to see a possible description appear on the packaging insert: "The idea is to get the best information in front of women."
President of the American College of Obstetrics and Gynecology or ACOG Dr. Steven Fleishman said the label change would make estrogen products more accessible to perimenopausal women and improve their lives.
"The updated labels will better allow patients and clinicians to participate in a shared decision-making process without unnecessary barriers when it comes to managing menopausal symptoms."
Although the official guidelines for estrogen therapy did not require its members to discuss the unique risks with patients.
The US Food and Drug Administration (FDA) convened a panel of experts in July to discuss removing them from at least low-dose vaginal estrogen.The agency then opened the document for comments from the public and received nearly 3,000 comments by the Sept. 24 deadline.
In its formal comment, ACOG wrote that it has long encouraged the agency to reconsider the warning labels on sexually administered low-dose estrogen products, but considers them separate from systemic estrogen products that deliver hormones into the body, such as pills and patches.
ACOG's Fleischman said in a statement Monday that "like all medications, estrogen products are not without risk, and their use should be based on personal discussion between patients and their caregivers."
For years, doctors pushed back against the risks of hormone therapy's benefits.In 2002, researchers renewed alarm about them because a long-term study called the Women's Health Initiative found that hormone therapy was associated with an increased risk of cancer and stroke.Since then, more research has shown that those risks are reversed and that treatment can reduce heart disease if prescribed earlier.
"Five fifty million women since the study 23 years ago were absent or volunteered if they knew from the life changing treatment of Hermoy.
Makary said doctors are often taught in medical school that menopause is mild and lasts a few years, but that's wrong."The symptoms appear in more than 80% of women. They last eight years on average. And for many women, they are severe, even debilitating: mood swings, night sweats, weight gain, hot flashes, divorce."
Although doctors pushed hard to lift the black box warning, they said the FDA task force convened in July deviated from the usual process for making these changes and lacked the rigor of the usual approach.
"We appreciate the interest of the FDA's expert panel in restarting hormone therapy warnings, such as a two -hour July 17 panel meeting, which should not be enough instead of a specialist panel meeting," ACOG wrote in an official statement to the agency.
The FDA's advisory committees consist of independent experts who review scientific presentations, discuss and debate the evidence on a given topic, and then vote on recommendations to the FDA.The agency does not always follow the recommendations of its committees, but it usually does.
"The focus on counseling is counterproductive to the agency's goal of increasing awareness."Acog writes."Therefore, acog recommends further exploration of the benefits of plant-based genetics for inclusion in public policy."
Macri said during the discussion session that the agency has chosen to hold advisory councils, "because [advisory councils] are bureaucratic, long, about always expensive."He said his FDA is also doing more fitness panels, which are less difficult and can be spontaneous but can be more robust.
In an email sent to the address, the agency shared several studies to support its decision.Studies have shown that these hormone treatments reduce the risk of Alzheimer's disease, heart attack, and hip fracture.However, the results are not new, having been published between 1980 and 1996. The agency also cites a 2004 analysis of 30 studies conducted between 1966 and 2003 that showed early initiation of hormone replacement therapy can save lives.
During the press conference, Macri presented a study he said was published three years ago in the medical journal Cancer that showed a reduction in heart disease among women using hormone replacement therapy.
