HRT "Black Box" Warning: Time To Go

There’s a lot of fear and misinformation around HRT, and one of the biggest myths is that HT is a highly significant cause of breast cancer. That is not the case. This is a remnant concept from 2002, with MANY caveats. Calls for the removal of the black box warning on hormone replacement therapy (HRT) stems primarily from the outdated and limited nature of the data from the Women's Health Initiative (WHI) study published in 2002. The WHI, while groundbreaking at the time, focused predominantly on a specific formulation of conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) in older, postmenopausal women, leading to concerns about its generalizability to the broader population of women considering HRT. This is why on July 17, 2025, the FDA met with a panel of experts, in open forum, to hear the petition of removing the black box warning on hormone replacement therapy. Listen in for details.

1. Writing Group for the Women's Health Initiative Investigators. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA.2002;288(3):321–333. doi:10.1001/jama.288.3.321

2. Manson JE, Crandall CJ, Rossouw JE, Chlebowski RT, Anderson GL, Stefanick ML, Aragaki AK, Cauley JA, Wells GL, LaCroix AZ, Thomson CA, Neuhouser ML, Van Horn L, Kooperberg C, Howard BV, Tinker LF, Wactawski-Wende J, Shumaker SA, Prentice RL. The Women's Health Initiative Randomized Trials and Clinical Practice: A Review. JAMA. 2024 May 28;331(20):1748-1760. doi: 10.1001/jama.2024.6542. PMID: 38691368.

3. NAMS: The 2022 hormone therapy position statement of The North American Menopause Society (Menopause)