The Food and Drug Administration says it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments prescribed to ease the symptoms of menopause and perimenopause.
The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes. That, FDA Commissioner Marty Makary told CBS News' Norah O'Donnell, scared women from using drugs that could in fact improve their health.
"We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits," Makary said.
The FDA convened an expert panel in July to discuss removing them from at least low-dose vaginal estrogen. The agency then opened a docket to solicit comments from the public and received nearly 3,000 by the Sept. 24 deadline.
In its formal comment, the American College of Obstetrics and Gynecology, or ACOG, wrote that it has "long encouraged" the agency to reevaluate warning labels on low-dose estrogen products administered vaginally, but it considers those separate from systemic estrogen products that deliver the hormone throughout the body, such as pills and patches.
Doctors had gone back and forth about the risks versus benefits of hormone replacement therapy for years. In 2002, researchers rang the alarm about them because a long-term study called the Women's Health Initiative found that hormone therapy was associated with increased risk of cancer and stroke. Since then, additional research has shown those risks were overstated, and the therapy can instead reduce heart disease when prescribed earlier.
Although doctors have pushed to have the black box warnings removed, they say the special panel the FDA convened in July deviated from the usual process for making such changes and lacked the rigor of the usual approach.
"While we appreciate the FDA Expert Panel's interest in reevaluating the label warnings on hormone therapy, a brief panel such as the two-hour July 17th Expert Panel should not be considered an adequate substitute for an advisory committee meeting," ACOG wrote in its formal comment to the agency.
FDA advisory committees are made up of independent experts who evaluate scientific presentations, discuss and debate the evidence on a given topic and then vote on recommendations for the FDA. The agency doesn't always follow its committees' recommendations, but it usually does.
"Forgoing the advisory committee process runs counter to the Agency's stated goal to increase transparency." ACOG writes. "Therefore, ACOG urges the FDA to delve deeper into the benefits of low-dose vaginal estrogen for [genitourinary syndrome of menopause] GSM and systemic estrogen therapy for vasomotor symptoms by convening separate advisory committee meetings, including opportunities for public engagement, before making decisions on possible labeling changes for these distinct menopausal hormone therapy options."
In an email to NPR, the agency shared several studies in support of its decision. The studies showed that these hormone therapies reduced the risk of Alzheimer's disease, heart attack and hip fracture. The findings aren't new, however, and were published between 1980 and 1996. The agency also cited an analysis of 30 studies from 1966 through 2003 that showed starting hormone replacement therapy earlier could save lives. It was published in 2004.
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