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The black box warnings on hormone treatments prescribed to treat menopause will be removed in an effort to encourage their use, U.S. health officials said Monday. The Food and Drug Administration plans to remove references to risk of breast cancer, heart disease and dementia on hormone replacement therapy products used to relieve symptoms of menopause and perimenopause. These labels had leaned on "misinformation" and scared off potential patients, FDA officials said. Raynaud's syndrome can be painful and annoying, but it's usually not dangerous "We now have a more nuanced understanding, and we want to put that fear machine in its proper context," FDA Commissioner Marty Makary told "CBS Mornings." "... Arguably with the exception of vaccines or antibiotics, there's no medication that can improve the health of women on a population level more than hormone replacement therapy." The black box warnings usually are traced back to the Women's Health Initiative, a long-term 2002 study that linked HRT to an increased risk of cancer and stroke. Hormone therapy's use as a menopause treatment plummeted in the ensuing decades. One study found that less than 5% of postmenopausal women used hormone therapy in 2020, compared to 26.9% in 1999. Subsequent research has criticized the Women's Health Initiative design and conclusions. In July, the FDA convened an expert panel to discuss the use of hormone therapy in menopause and solicited public comments. It received almost 3,000. Medical associations including the American Urogynecologic Society and American College of Obstetricians and Gynecologists wrote comments in favor of revising the labels, though they limited their recommendations to low-dose vaginal estrogen treatments. "Estrogen is a key hormone for women's health," said Alicia Jackson, the director of the Advanced Research Projects Agency for Health, a federal agency created in 2022 to fund biomedical breakthroughs. "Every single part of a woman's body depends on estrogen to operate at its best — including the brain, bones, heart and muscles. The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives." The FDA said updated labels will recommend HRT for patients under age 60 or within 10 years of the onset of menopause. Estrogen-only products will still carry a warning about endometrial cancer. The FDA also is approving a pair of drugs that treat menopause symptoms — a generic version of Premarin, a commonly used HRT, and non-hormonal treatment that treats hot flashes. Hormone therapy replaces the estrogen the body ceases making after menopause, which happens on average at 52. There are two main types: systemic therapy and low-dose vaginal estrogen. Systemic therapy is administered through a pill, skin patch, ring, gel, cream or spray. It is absorbed by the entire body, and is used to treat many menopause symptoms. Low-dose vaginal estrogen is used to treat vaginal and urinary menopause symptoms. It is administered via cream, tablet or ring, and typically has less estrogen than systemic therapy. Follow Kristin & PhillyVoice on Twitter: @kristin_hunt | @thePhillyVoice Like us on Facebook: PhillyVoice Have a news tip? Let us know.
