FDA to Drop Warnings on Hormone Replacement Therapy for Menopause, Amid Growing Support
The Food and Drug Administration (FDA) has announced that it will be removing warnings about the risks of heart disease, breast cancer, and dementia from hormone replacement therapy products used to treat menopause symptoms. The decision comes after years of criticism over the design and conclusions of a 2002 study that initially linked HRT to increased cancer and stroke risks.
The black box warning system was put in place following the Women's Health Initiative (WHI) study, which found a potential link between HRT and certain health issues. As a result, hormone therapy usage plummeted in the years following the study, with less than 5% of postmenopausal women using it in 2020 compared to over 26% in 1999.
However, subsequent research has challenged the design and conclusions of the WHI study, leading the FDA to convene an expert panel to discuss the use of hormone therapy in menopause. Medical associations, including the American Urogynecologic Society and American College of Obstetricians and Gynecologists, have written comments in favor of revising the labels.
According to Dr. Alicia Jackson, director of the Advanced Research Projects Agency for Health, "Estrogen is a key hormone for women's health," and removing the black box warning based on the best science and data will empower millions of women to live longer, healthier lives.
The FDA plans to update the labels, recommending hormone therapy for patients under 60 or within 10 years of menopause onset. Estrogen-only products will still carry a warning about endometrial cancer.
In addition, the FDA is approving new treatments for menopause symptoms, including a generic version of Premarin and a non-hormonal treatment that targets hot flashes.
The Food and Drug Administration (FDA) has announced that it will be removing warnings about the risks of heart disease, breast cancer, and dementia from hormone replacement therapy products used to treat menopause symptoms. The decision comes after years of criticism over the design and conclusions of a 2002 study that initially linked HRT to increased cancer and stroke risks.
The black box warning system was put in place following the Women's Health Initiative (WHI) study, which found a potential link between HRT and certain health issues. As a result, hormone therapy usage plummeted in the years following the study, with less than 5% of postmenopausal women using it in 2020 compared to over 26% in 1999.
However, subsequent research has challenged the design and conclusions of the WHI study, leading the FDA to convene an expert panel to discuss the use of hormone therapy in menopause. Medical associations, including the American Urogynecologic Society and American College of Obstetricians and Gynecologists, have written comments in favor of revising the labels.
According to Dr. Alicia Jackson, director of the Advanced Research Projects Agency for Health, "Estrogen is a key hormone for women's health," and removing the black box warning based on the best science and data will empower millions of women to live longer, healthier lives.
The FDA plans to update the labels, recommending hormone therapy for patients under 60 or within 10 years of menopause onset. Estrogen-only products will still carry a warning about endometrial cancer.
In addition, the FDA is approving new treatments for menopause symptoms, including a generic version of Premarin and a non-hormonal treatment that targets hot flashes.