FDA deleting menopause hormone drug warning risks all women’s health | Opinion
On Nov. 10, the Food and Drug Administration announced that it will remove the “boxed warning” on the drug label for menopausal hormone therapy or MHT that factually links the therapy to cardiovascular disease, stroke, breast cancer and dementia. Boxed warnings — formerly known as “black box warnings” — are the strongest alerts on medications’ package inserts. While most of the language on a drug label is negotiated between a drug company and the FDA, the agency can mandate a boxed warning.
This announcement may be the most damaging decision that this administration has made against public health. It’s news that impacts any woman nearing or at menopause — and anyone who cares about a woman at that age. According to the latest census data estimates, that means more than 100,000 women in Kansas City and about 670,000 women throughout Kansas.
No new data exists to support these label changes, which fly in the face of known science. Not only did FDA Commissioner Marty Makary minimize the known risks of menopausal hormone therapy, but he also claimed that the therapy prevents cardiovascular disease, dementia and divorce — and has threatened to put the supposed benefits of MHT on the label. Most of the studies cited by the FDA to support this new position are decades-old observational studies, now irrelevant, that have been superseded by definitive randomized controlled trials.
Observational studies provide clues, not proof: The old studies that Makary cites compared hormone users to non-users, and indicated that women who took hormones had less cardiovascular disease and dementia than non-users. To test whether the association was real, the U.S. government funded the Women’s Health Initiative, a randomized controlled trial that assigned more than 25,000 women to hormones or placebos and then followed them for many years to monitor health outcomes.
The Women’s Health Initiative found no benefit of hormones for cardiovascular disease. Instead, combined estrogen-progestin therapy increased the risk of breast cancer, strokes, blood clots and dementia, among other conditions. There were some benefits, including reduced fractures and a small decrease in diabetes. Estrogen-only therapy decreased breast cancer risk. These benefits, however, were far outweighed by the harms.
The Women’s Health Initiative findings were a shock to the medical profession, which had been prescribing hormones as a kind of disease prevention panacea for many years. It turned out that observational studies were misleading, because women who chose to take hormones were different from non-users. Hormone users smoked less, exercised more, had lower blood pressure and were wealthier than non-users. Hormone users also had less heart disease. Taking hormones was just one of many things these women were doing to preserve their health — but it turns out that it was exercising and avoiding smoking, not hormones, that made the difference. Also, doctors avoided giving hormones to women with a personal or family history of heart disease, because they knew that hormones caused blood clots, so more women who avoided hormones had heart disease.
Increase dementia, breast cancer
Makary said the FDA has done a comprehensive review of the Women’s Health Initiative data, but if there is one, it’s being kept behind closed doors. Instead, a misinformed, inadequately referenced Journal of the American Medical Association commentary by Makary and his staff is all that’s been published. The piece reiterates false claims that menopausal hormone therapy prevents cardiovascular disease and dementia, and that the purported risk of breast cancer is overblown.
In fact, combined hormone therapy (estrogen-progestin combinations) increases dementia and cognitive problems, has no effect on cardiovascular disease and increases the incidence of breast cancer — a risk that got stronger over the 20 years the subjects in the Women’s Health Initiative were followed up with. Note that Makary says only that hormones don’t increase “breast cancer deaths,” carefully avoiding the truth that hormones cause breast cancer. Minimizing the effect of a breast cancer diagnosis and treatment is bad enough, but Makary neglects to mention increased deaths from other cancers. Estrogen increases deaths from ovarian cancer, and estrogen-progestin combinations increase deaths from lung cancer.
Makary also fails to mention other significant risks. Combined hormone therapy (estrogen-progestin combinations) also increases stroke, pulmonary embolism and gallbladder disease. Estrogen alone (used only in women without a uterus) increases stroke, pulmonary embolism, gallbladder disease and mild cognitive impairment.
Hormones can effectively treat uncomfortable hot flashes or painful sex, and those benefits may outweigh harms in symptomatic women. But menopausal hormone therapy should never be used to prevent disease. It is horrifying that a regulatory agency is making unsupported claims of benefits for a drug, while actively suppressing drug harms and pushing misinformation. This label change is a travesty.
Physician Adriane Fugh-Berman is a professor in the Department of Pharmacology and Physiology and the Department of Family Medicine at Georgetown University Medical Center, where she directs PharmedOut, a research and education project that promotes rational prescribing. She has authored many peer-reviewed papers on menopausal hormone therapy, and co-authored the book “The Truth About Hormone Replacement Therapy.” She is a paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical marketing practices. Judy Butler is the senior research fellow at PharmedOut.
This story was originally published December 3, 2025 at 5:09 AM.