FDA Removes Black Box Warning on 6 Menopausal Hormone Therapy Products

The FDA officially approved significant labeling changes for 6 menopausal hormone therapy products, marking a major shift in how these medications are communicated to health care providers and patients. The decision removes risk statements regarding cardiovascular disease, breast cancer, and probable dementia from the boxed warning, which is the agency’s most prominent safety-related alert.¹

“This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” Health and Human Services Secretary Robert F. Kennedy Jr. said in the news release.¹ “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.”

Kennedy stated that the removal of these warnings ensures women receive accurate information free from exaggeration, reflecting a commitment to update guidance as science evolves. This regulatory action follows a comprehensive scientific review initiated in November 2025 and affects several categories of hormone replacement therapy, including systemic combination therapy, estrogen-alone therapy, progestogen-alone therapy for women with a uterus, and topical vaginal estrogen.¹

For pharmacists, these updates align with clinical evidence suggesting that the benefits of hormone therapy are most pronounced when treatment begins near the onset of menopause. FDA Commissioner Marty Makary noted that while menopause symptoms such as hot flashes and night sweats can significantly reduce quality of life for years, only a small fraction of women who could benefit from these treatments are currently using them.^1,2

Data from 2020 showed that of approximately 41 million US women in the 45 to 64 years age bracket, only about 2 million received a prescription for hormone therapy. Research indicates that women who initiate therapy within 10 years of menopause onset, generally before 60 years, experience a reduction in all-cause mortality and fractures.^1,2

Pharmacists remain at the forefront of individualizing these treatments, as the effectiveness and safety of hormone therapy are highly dependent on the choice of agent, dosage, route of administration, and duration of use. Systemic estrogen therapy remains the gold standard for moderate-to-severe vasomotor symptoms, while low-dose local preparations, such as vaginal rings, tablets, and creams, are preferred for managing vulvovaginal atrophy and genitourinary symptoms. For patients with an intact uterus, pharmacists must ensure the regimen includes a progestogen to prevent estrogen-induced endometrial hyperplasia and the subsequent risk of endometrial cancer.^2-4

Although the removal of certain boxed warnings clarifies risk considerations, pharmacists must continue to monitor for other established adverse effects. Major risks still associated with these agents include venous thromboembolism, ischemic stroke, and gallbladder disease. Clinical guidelines suggest that transdermal patches, gels, and sprays may confer a lower risk of blood clots and stroke compared to oral pills, providing a safer alternative for patients with moderate cardiovascular risk. Additionally, pharmacists should be aware of drug-drug interactions, particularly with medications that induce or inhibit the CYP3A4 system, which can alter the serum concentrations and efficacy of estrogen products.^1-3

The role of the pharmacist is also vital in counseling patients on nonhormonal alternatives when hormone therapy is contraindicated, such as in patients with a history of breast cancer, stroke, or active liver disease. Options like selective serotonin reuptake inhibitors, gabapentin, and clonidine have shown efficacy in reducing hot flashes for those who cannot use hormones.^2,3

Furthermore, professional organizations like the American College of Obstetricians and Gynecologists emphasize the use of FDA-approved products over compounded bioidentical hormones, noting that compounded drugs lack FDA regulation and may vary dangerously in strength and purity. By providing evidence-based guidance on the newly updated labels and the variety of available formulations, pharmacists can help women make better-informed decisions to manage their menopausal health effectively.^1-3

READ MORE: Women’s Health Resource Center

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REFERENCES

1. FDA approves labeling changes to menopausal hormone therapy products. FDA. February 12, 2026. Accessed February 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

2. Sanchez CK, Rumbellow S. Hormone Replacement Therapy for Menopausal Symptoms. US Pharm. 2018;43(9):21-26. https://www.uspharmacist.com/article/hormone-replacement-therapy-for-menopausal-symptoms

3. Mayo Clinic. Hormone therapy: is it right for you? April 18, 2025. Accessed February 12, 2026. https://www.mayoclinic.org/diseases-conditions/menopause/in-depth/hormone-therapy/art-20046372

4. American College of Obstetricians and Gynecologists. Hormone Therapy for Menopause. Updated February 2024. Accessed February 12, 2026. https://www.acog.org/womens-health/faqs/hormone-therapy-for-menopause