Is HRT in menopause healthy? US label change triggers debate

"On Monday, the US Food and Drug Administration announced its intention to eliminate safety warnings for hormone replacement therapy creams, pills and patches used to treat the symptoms of menopause. The move, which the FDA called " a historic action to restore gold-standard science to women's health", is drawing both praise and concern from scientists and advocates."

""I'm afraid comprehensive discussion about the risks and benefits may not occur in absence of that warning," says Stephanie Faubion, the director of Mayo Clinic's Center for Women's Health in Jacksonville, Florida, and medical director of The Menopause Society a non-profit organization based in Pepper Pike, Ohio, that provides tools and resources to health-care professionals. "We need to end up somewhere in the middle.""

"Hormone therapy was widely prescribed for decades to ease common menopausal symptoms such as hot flushes, night sweats and poor sleep. But prescriptions plunged worldwide in 2002 after an initial report from the Women's Health Initiative (WHI) - a long-term US study - suggested that postmenopausal participants who were taking oestrogen and progestin (a synthetic form of progesterone) had slightly increased risks of breast cancer, heart attack and stroke. The findings - widely misinterpreted and overgeneralized - sparked fear among women and clinicians."

FDA intends to remove long-standing safety warnings for menopausal hormone replacement creams, pills and patches. The action aims to correct perceived overcautious labeling and could increase appropriate use among women who may benefit. Critics worry that removing warnings entirely or allowing broad claims might lead to undercommunication of risks and overpromotion of benefits. Many warnings were added after the 2002 Women's Health Initiative findings that linked combined oestrogen and progestin to small increases in breast cancer, heart attack and stroke. Those findings were widely misinterpreted, causing prescriptions to plunge and contributing to chronic underuse. Balanced, individualized risk–benefit discussions remain important.

Read at Nature