- The Food and Drug Administration (FDA) has approved drug labeling changes to black box warnings on six hormone replacement therapy (HRT) treatments for menopause.
- The federal agency requested that HRT manufacturers update wording regarding various risks, such as cardiovascular disease, breast cancer, and dementia.
- Experts say removing the warnings may help reduce stigma around HRT and facilitate a dialogue between individuals and healthcare professionals.
The Food and Drug Administration (FDA) has approved drug labeling changes to six hormone replacement therapy (HRT) products used to treat menopause symptoms, the federal agency
The products had previously carried the strictest black box warning labels for risks of cardiovascular disease, breast cancer, and dementia. Black box warnings are issued by the FDA to highlight serious risks of major injury or death associated with a medication.
The FDA initiated the labeling changes in November 2025 after conducting a comprehensive review of the risks associated with HRT products.
The FDA requested 29 drug companies to submit labeling changes. The first six HRT products with approved labeling changes include those that fall into the four main categories of HRT medication for menopausal females:
- systemic combination therapy (estrogen and progestogen)
- systemic estrogen-alone therapy
- systemic progestogen-alone therapy for females with a uterus using systemic estrogen
- topical vaginal estrogen therapy
Black box warning labels have been included on HRT products for more than two decades, which the FDA said has sown fear and confusion around hormone therapy, the FDA stated in a
“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 a
“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.”
The FDA requested that HRT manufacturers update the language on black box warnings pertaining to cardiovascular disease, breast cancer, and dementia risks.
However, the FDA is not seeking to remove the warnings regarding endometrial cancer on systemic estrogen-alone products.
The FDA’s decisions were based on an assessment of the current literature and a comprehensive review by a panel of experts, including a reanalysis of data from younger cohorts who began HRT treatment within 10 years of entering menopause.
In November, FDA Commissioner Marty Makary, MD, MPH, said that millions of women have been denied the potential health benefits of HRT during menopause due to “distortion of” risk factors included on the warning labels.
“For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear,” Makary said in a
HHS states that removing black box warnings from HRT products could help address the underutilization of these products to treat menopause symptoms. Experts are in agreement.
“The FDA removal of the black box warning for HRT will increase clinician awareness and education across all fields of medicine, and will ultimately expand access to appropriate, individualized treatment for those experiencing menopause,” said Nataki Douglas, MD, reproductive endocrinologist and chief scientific officer at Extend Fertility.
HRT was first approved by the FDA to treat certain menopause symptoms in the 1940s. However, studies conducted in the 1990s by the Women’s Health Initiative (WHI) found that there were potential risks of cardiovascular disease, breast cancer, and pulmonary embolism. Following these studies, the use of HRT fell by 45%.
“Initially, the ‘black box’ warning cautioned women and healthcare providers that hormone therapy would increase their risks of blood clots, breast cancer and strokes, which was based on the notorious and faulty WHI study done in 2002,” said Sherly Ross, MD, a board certified OB-GYN and women’s health expert noted this about the initial use of the black box warning and what the removal means.
“After over 20 years of waiting, we now have a restored trust and confidence in safely using hormone therapy for menopausal women as a recommended medication for quality of life and healthy aging,” Ross told Healthline.
Experts say that removing the black box warnings from HRT products will improve menopause treatment outcomes for symptoms ranging from hot flashes to night sweats and sleep issues.
“For the
She said the benefits of hormone therapy become even more pronounced when the medication is prescribed within the first
“Starting hormone therapy is an individualized process that should be discussed with a qualified healthcare provider, weighing the benefits versus the risks,” Ross said.
Douglas echoed these remarks, calling the black box removal an “important first step” that raises awareness among clinicians and patients alike about the evidence-based benefits and risks of HRT.
“It will encourage more open and informed patient–provider discussions and lead to increased referrals of perimenopausal and postmenopausal individuals to specialists who provide menopause-focused care,” Douglas told Healthline.