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WASHINGTON — The Food and Drug Administration is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits. Commissioner Marty Makary wrote in a Wall Street Journal op-ed on Monday that the FDA is removing black box warning labels from all-combined estrogen-progestogen, estrogen-only, other estrogen-containing, and progestogen-only products used for hormone therapy. Advertisement “These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment,” he wrote. The impetus for the black box warning was a 2002 landmark study called the Women’s Health Initiative that suggested that hormone therapy came with an increased risk of heart disease and breast cancer. The study specifically focused on combination therapy among older, postmenopausal women, but the results were interpreted broadly, ultimately driving down rates of uptake for the therapies. Since then, a growing body of research has shown that hormone therapy can actually be beneficial to menopausal women’s heart health, reducing insulin resistance and improving other cardiovascular biomarkers. These therapies can be used to alleviate menopausal symptoms including hot flashes, sleeping troubles, vaginal dryness, and painful sex. Advertisement “In my professional opinion, the demonization of hormone replacement therapy for perimenopausal women and the underappreciation of its health benefits ranks among the greatest mistakes of modern medicine,” Makary wrote. For years, many clinicians have advocated for the FDA to remove the black box warning from hormone replacement products, focused largely on vaginal products like topical cream or a ring, where hormones are not fully absorbed into a person’s bloodstream. In July, FDA officials convened an expert panel to discuss the risks and benefits of hormone therapies for menopausal women as well as opened public comments. There, physicians emphasized the relative safety of the drugs, also focused mainly on local estrogen. Vaginal products are “categorically safe for all women, period,” said internist Heather Hirsch, adding that she believes the warnings on systemic hormone therapy are broad and poorly defined. (Hirsch founded The Collaborative, a telehealth practice that prescribes hormones to women in midlife stages.) “Science evolves, and so must our warning labels,” said physician Rachel Rubin, who runs a urology and sexual medicine practice. Some clinicians, while agreeing that it makes sense to remove the black box warning, noted that the FDA has not followed the typical process to make the decision. The panel was a short and relatively informal conversation, not a traditional scientific advisory committee to review new safety data. There were not methodologists, epidemiologists, or oncologists present, as physician and writer Jen Gunter pointed out in her blog. The American College of Obstetricians and Gynecologists has long shown support for reevaluating the label on local estrogen products, but in a comment submitted to the FDA in September, the organization “strongly encouraged” the agency to host a formal advisory committee meeting. The group also recommended an entirely separate process take place regarding systemic therapies. Makary wrote Monday that the removal of the black box warning is “an important step toward treating menopause with the same scientific rigor we use in other areas of medicine.” Advertisement
