US Health Officials Ditch Warnings Over Hormone Therapy for Menopause, Hoping to Revive Usage.
In a significant U-turn, US health regulators announced that they will be removing warnings about the potential risks of heart disease and cancer associated with hormone replacement therapy (HRT) used to treat menopausal symptoms.
The decision comes after decades of controversy surrounding HRT, which was initially linked to an increased risk of certain cancers and cardiovascular issues in a landmark 2002 study known as the Women's Health Initiative. The study led to a significant decline in the use of HRT among postmenopausal women, with just 4% using the therapy in 2020, down from 27% in 1999.
However, subsequent research has raised questions about the study's design and conclusions, leading health organizations such as the American Urogynecologic Society and the American College of Obstetricians and Gynecologists to call for a revision of the labels. The FDA has now responded with updated guidance that recommends HRT for women under 60 or those within 10 years of menopause onset.
Estrogen-only products, however, will still carry warnings about endometrial cancer. The FDA is also approving two new drugs to treat menopause symptoms: a generic version of Premarin and a non-hormonal treatment for hot flashes.
The move has been welcomed by health advocates who argue that the benefits of HRT far outweigh the risks. "Estrogen is a key hormone for women's health," said Alicia Jackson, director of the Advanced Research Projects Agency for Health. "Every single part of a woman's body depends on estrogen to operate at its best β including the brain, bones, heart and muscles."
The FDA Commissioner described the updated guidance as an "incredible step forward" that aims to empower millions of women to live longer, healthier lives.
In a significant U-turn, US health regulators announced that they will be removing warnings about the potential risks of heart disease and cancer associated with hormone replacement therapy (HRT) used to treat menopausal symptoms.
The decision comes after decades of controversy surrounding HRT, which was initially linked to an increased risk of certain cancers and cardiovascular issues in a landmark 2002 study known as the Women's Health Initiative. The study led to a significant decline in the use of HRT among postmenopausal women, with just 4% using the therapy in 2020, down from 27% in 1999.
However, subsequent research has raised questions about the study's design and conclusions, leading health organizations such as the American Urogynecologic Society and the American College of Obstetricians and Gynecologists to call for a revision of the labels. The FDA has now responded with updated guidance that recommends HRT for women under 60 or those within 10 years of menopause onset.
Estrogen-only products, however, will still carry warnings about endometrial cancer. The FDA is also approving two new drugs to treat menopause symptoms: a generic version of Premarin and a non-hormonal treatment for hot flashes.
The move has been welcomed by health advocates who argue that the benefits of HRT far outweigh the risks. "Estrogen is a key hormone for women's health," said Alicia Jackson, director of the Advanced Research Projects Agency for Health. "Every single part of a woman's body depends on estrogen to operate at its best β including the brain, bones, heart and muscles."
The FDA Commissioner described the updated guidance as an "incredible step forward" that aims to empower millions of women to live longer, healthier lives.