FDA menopause hormone therapy: The U.S. Food and Drug Administration announced on Monday that it will remove the strictest “black box” warnings from hormone therapies used to manage menopause symptoms. The move could make these treatments more accessible to women and healthcare providers, who have long avoided them due to safety concerns. FDA Commissioner Marty Makary said the decision comes after a thorough review of scientific research, feedback from an expert panel in July, and a public comment period."After 23 years of outdated caution, the FDA is now stepping back from the fear-based messaging that has kept women from this life-changing—and sometimes,life-saving—treatment," Makary said at a press briefing."We are responding to women who have been challenging the paternalistic approach in medicine, and to female medical students calling for better menopause education in medical training," he added.The agency is also greenlighting two new treatments for menopausal symptoms. This includes a generic version of Pfizer’s Premarin and a non-hormonal option for moderate to severe vasomotor symptoms, like hot flashes.What Is Hormone Replacement Therapy?Hormone replacement therapy (HRT) is a treatment for people experiencing menopause symptoms. Doctors may also call it hormone therapy (HT), especially when prescribed after age 50. Generally, “HRT” is used for people starting treatment at a younger age, often before 40.During menopause, the ovaries produce less estrogen, which can lead to uncomfortable symptoms, including:Hot flashesNight sweatsVaginal dryness and painful intercourseMood swings, irritability, or depressionInsomniaUrinary incontinenceHRT works by replacing the hormones your body is no longer making enough of, helping to relieve these symptoms. It can also help prevent bone loss, such as osteoporosis and osteopenia, which can occur when estrogen levels drop.Hormone Replacement Therapy: When Should You Start Hormone Therapy?Dr. Joann Pinkerton, a menopause specialist at the University of Virginia Health, recommends starting estrogen therapy before age 60 or within ten years of the onset of menopause, which begins one year after your last period. Many women continue taking birth control through perimenopause, which can help manage hot flashes and night sweats as hormone levels fluctuate.Once menopause is complete and pregnancy prevention is no longer a concern, continuing birth control may not make sense. “Birth control usually contains more estrogen than is used in menopause hormone therapy,” Pinkerton says, “so that’s a good time to discuss hormone therapy options with your provider.”Menopause Hormone Therapy FDA: How Long Should You Be on Hormone Therapy?Typically, women use hormone therapy for three to five years, though this is not a strict rule. “For those with ongoing symptoms or bone loss—which can be addressed with hormone therapy—we continue treatment,” Pinkerton explains. She emphasizes the importance of reviewing treatment annually. “It’s about working with each patient to find the safest and most effective approach.”Lauren Streicher from Northwestern University, as per NPR, adds, “We don’t stop hormone therapy simply because three to five years have passed.” She notes that menopause symptoms can last longer for some women, with Black and Hispanic women often experiencing extended periods of discomfort.HRT Therapy: Who Should Avoid Hormone Therapy?Certain medical conditions can make hormone therapy risky. Women with estrogen-sensitive breast or uterine cancers, or those who have had, or are at high risk for heart attack, stroke, blood clots, or pulmonary embolism, should avoid HRT.“Women need to have a detailed discussion with a knowledgeable healthcare provider,” Pinkerton says. “It’s crucial to understand what benefits and risks apply to you personally.”Whether HRT is right for you is a conversation to have with your healthcare provider. While hormone therapy can ease menopausal symptoms, it carries potential risks. Discussing these benefits and risks with your doctor will help determine if HRT is suitable for your needs.
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