The Food and Drug Administration (FDA) has announced the removal of black box warnings from hormone replacement therapies (HRT) used to treat menopause symptoms. This significant decision, revealed by the U.S. Department of Health and Human Services, reverses a policy implemented in the early 2000s that linked these therapies to increased risks of breast cancer, heart disease, and stroke in some women.
Black box warnings serve as the most stringent safety alerts for medications, reflecting serious health concerns. During a press conference, FDA Commissioner Marty Makary described the previous use of these warnings for menopause-related HRT as “unscientific.” Experts believe that the removal of these labels may enhance access to hormone therapies for women experiencing menopausal symptoms such as hot flashes and night sweats.
Research conducted following the addition of the warnings in 2003 indicated that the risks associated with hormone therapy may have been overstated, leading to a decline in both the usage of HRT and doctors’ willingness to prescribe it. According to Nanette Santoro, an obstetrician-gynecologist at the University of Colorado Anschutz and a leading researcher with the Women’s Health Initiative, the current decision could positively impact women who have been underserved in their treatment options.
The Women’s Health Initiative, which began in 1991, has conducted extensive studies on heart disease, cancer, and osteoporosis in postmenopausal women. Santoro noted that there has been a growing recognition of the need for hormone treatments, stating, “There are too many women who suffer in silence.”
Despite these potential benefits, there are concerns regarding the clarity of the FDA’s announcement. Jim O’Neill, Deputy Secretary of Health and Human Services, emphasized that the removal of the warnings could allow many women to reduce their risks of fractures, heart disease, and cognitive decline. However, Santoro cautioned that the evidence does not robustly support claims of significant health benefits associated with hormone therapy.
The scrutiny surrounding HRT is occurring alongside a broader evaluation of FDA decisions related to various health treatments, including vaccines. In July, a panel of experts reviewed the scientific data regarding the risks and benefits of hormone therapy for menopause, leading to today’s decision. It is important to note that not all hormone replacement therapies are affected by this announcement; some estrogen-only treatments will continue to carry warnings related to endometrial or uterine cancer risks. Kemi Doll, a gynecologic oncologist at the University of Washington, highlighted the importance of considering these risks, particularly for women who have a uterus.
Menopause typically occurs when estrogen levels decline, resulting in the cessation of menstruation for at least 12 months. Hormone therapy can alleviate various symptoms associated with menopause by administering synthetic hormones, primarily estrogen or a combination of estrogen and progesterone. These therapies can be delivered through pills, patches, gels, or vaginal rings.
Historically, the use of hormone therapy surged in the 1990s when research suggested it could effectively reduce the risk of osteoporosis. However, studies in the early 2000s revealed an association between hormone therapy and adverse health outcomes, leading to a significant decline in usage. Makary, alongside other health officials, criticized earlier findings from the Women’s Health Initiative, asserting that the risks were primarily observed in older women taking outdated drug formulations. Subsequent research has shown no substantial risks or benefits associated with these older versions.
The delivery method for hormone therapy is also crucial; vaginal formulations usually present lower risks compared to oral pills, which undergo liver metabolism. Research from 2019 indicated that extended use of hormone therapy could elevate breast cancer risk, underscoring the need for careful patient selection.
Additionally, the FDA has approved two new menopause treatments: a generic version of the oral hormone therapy tablet Premarin, which contains a blend of estrogen hormones, and Bayer’s Lynkuet, a non-hormonal option for treating menopausal symptoms.
While hormone therapies do have associated risks, particularly for individuals with a history of reproductive cancers or blood clots, the potential benefits for many women, especially those in their 50s, may outweigh these risks. Doll emphasized the necessity for ongoing research to address gaps in current understanding.
“There’s a need for new studies that reflect the questions relevant to women today,” she noted, highlighting the importance of advancing research to provide clearer guidance on hormone therapy. As of now, the evidence does not support the more optimistic claims made by some officials regarding hormone therapy’s overall health benefits.
Overall, the FDA’s decision marks a pivotal moment in the conversation surrounding menopause treatment, with the potential to reshape how hormone replacement therapies are perceived and utilized in clinical practice.
