ADR that result in revision of patient information
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| The United States: FDA approves labeling changes to menopausal hormone therapy products |
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The United States Food and Drug Administration (FDA) announces that it has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.
“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. “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 initiated the removal of these warnings in November 2025, following a comprehensive review of the scientific literature. At the FDA’s request, 29 drug companies have submitted proposed labeling changes. This first batch of six products with approved labeling changes includes products from each of the four categories of HRT for menopausal women:
- Systemic combination therapy (estrogen and progestogen)
- Systemic estrogen-alone therapy
- Systemic progestogen-alone therapy for women with a uterus using systemic estrogen
- Topical vaginal estrogen therapy
“With today’s action, we are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”
Menopause is a normal life stage, but its symptoms can significantly reduce quality of life. Common symptoms include hot flashes and night sweats (called vasomotor symptoms or VMS); vaginal, vulvar, and urinary tract changes caused by lower estrogen levels; and osteoporosis (thinning bones), which increases fracture risk.
The FDA has approved multiple hormone therapies for moderate-to-severe hot flashes, vaginal dryness and discomfort, and preventing bone loss. In addition, randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Just a small fraction of women who could benefit from these treatments, however, are using them. In 2020, about 41 million U.S. women were ages 45–64 — yet only about 2 million women ages 46–65 received a hormone-therapy prescription.
Today’s action will allow women, working with their healthcare professionals, to make better-informed decisions about their treatment plan for menopause symptoms. Women are encouraged to consult the drug label for more detailed information about the benefits and risks of these products.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
In Hong Kong, hormone replacement therapy (HRT) products are registered pharmaceutical products. So far, the Department of Health (DH) has not received any adverse drug reaction reports with regard to HRT.
Related news regarding the associated risk of HRT was previously issued by FDA and various overseas drug regulatory authorities, and was posted on the Drug Office website on since 31 Aug 2019, with the latest update posted on 11 Nov 2025. Letters to inform local healthcare professionals were issued by DH on 2 Sep 2019. In Dec 2021, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels and/or package inserts should contain safety information about the risk of breast cancer, stroke and/or endometrial cancer for different types of locally registered HRT products. The risk of breast cancer, cardiovascular diseases, dementia and endometrial cancer associated with the use of HRT is also documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. As previously reported, the above FDA announcement will be discussed by the Registration Committee of the Pharmacy and Poisons Board of Hong Kong.
Ends/Friday, Feb 13, 2026
Issued at HKT 16:00
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