At long last, the Food and Drug Administration will remove a “black box warning” label required on the packaging of most types of menopause hormone therapies. The decision, announced last week, will finally bring regulation in line with science.
The agency’s action corrects a wrong that has frightened generations of women away from these medications. In 2002, findings from the influential Women’s Health Initiative were widely interpreted to mean that hormone therapy raised the risks of breast cancer, heart attack and stroke. But this was based on a crucial misunderstanding of the WHI’s study, which examined whether hormone therapy could prevent chronic diseases in postmenopausal women, not whether it was safe or effective for managing menopausal symptoms.
The right takeaway should have been that hormone therapy is not recommended for preventing chronic diseases in older women, not that it is unsafe for treating symptoms in younger women. Unfortunately, that distinction was lost.
Not long after the WHI findings were published, the FDA imposed the black box label, its strongest warning. The effect was staggering: In 2001, American doctors wrote 112 million hormone therapy prescriptions. By 2008, this dropped to fewer than 32 million. The proportion of eligible women receiving them declined from about 27 percent in 1999 to less than 5 percent in 2020.
The FDA is finally rectifying this error. In a new JAMA article explaining the decision, Commissioner Marty Makary and his colleagues highlighted three key points.
First, they clarified the important distinction between low-dose vaginal estrogen and systemic hormone therapy, both of which have been subjected to the black box warnings. Systemic hormones — typically given as a pill, skin patch, gel or spray — are absorbed into the bloodstream and used to relieve whole-body symptoms such as hot flashes and night sweats. Vaginal estrogen, by contrast, is a cream or tablet that acts directly on vaginal tissue and is only minimally absorbed. It treats a specific condition called genitourinary syndrome of menopause, which causes vaginal dryness, pain and bleeding during intercourse, and recurrent bladder and kidney infections.
Lumping these two therapies together never made scientific sense. No evidence links the vaginal formulation to the conditions listed on the black box label. Yet, the warning discouraged patients and clinicians alike from using it, leaving women to suffer preventable complications. The FDA is right not only to remove the warning but also to clarify that this is local rather than systemic treatment, and that age-related cautions do not apply. Vaginal estrogen can be used safely, even many years after menopause.
Second, the FDA retained a critical safety message: Systemic estrogen products will continue to carry a warning label about the risk of endometrial cancer in women who have not had their uterus removed. That risk is because estrogen, when used on its own, can stimulate the uterine lining to grow too much. But that can mitigated by adding another hormone, progestogen, which counteracts that effect. This a nuanced approach should remove unnecessary fear while maintaining clear guidance where genuine risk remains.
Third, the agency clarified who stands to benefit most from systemic hormone therapy. The updated labels will include guidance to begin treatment within 10 years of the onset of menopause symptoms, generally before age 60, when benefits outweigh risks. Beyond that window, risks such as heart disease or stroke increase. This aligns with recommendations from leading professional groups, including the Menopause Society and the American College of Obstetricians and Gynecologists, and will help women and their doctors make better-informed decisions about therapies tailored to their age, symptoms and overall health profile.
Even as the FDA deserves praise for addressing past errors, it should be careful not to overcorrect. In their JAMA editorial, the FDA leaders made the eyebrow-raising claim that “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.” They also included sweeping language about range of potential benefits, including for cardiovascular, bone and cognitive health.
Those effects might well be secondary benefits for women who begin treatment for menopausal symptoms, but hormone therapy is not approved for the prevention of these conditions. Regulators must guard against opportunistic companies attempting to portray hormone therapy as a cure-all for aging. The treatment should remain what science supports it to be: a valuable tool for women to relieve bothersome menopausal symptoms and improve quality of life.
The FDA needs to address other questions, such as how labels will differ by dosage or delivery method and how to guide women with a history of cancer or blood clots. The agency also skipped its usual process of convening a formal advisory committee, which would have surfaced these concerns through open debate. As both advocates of this guidance and its critics have pointed out, transparency and process matter. They build public trust, even when the final decision is correct.
The post The FDA finally corrects its error on menopause hormone therapy
appeared first on Washington Post.
