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Today, the FDA initiated the removal of “black box” warnings on all forms of hormone therapy.<\/p>\n<\/li>\n
The two doctors Women’s Health spoke with agree that the black box warning should be removed from local estrogen therapy products.<\/p>\n<\/li>\n
There’s some controversy in the medical community around the broad strokes nature of the FDA recommendation, especially as it pertains to systemic hormone therapy, with some doctors saying further research is needed.<\/p>\n<\/li>\n<\/ul>\n
Back in July, the Food and Drug Administration (FDA) hosted a panel of experts to discuss the safety of hormone therapy<\/a> for women in menopause and its black box warning, which is the most serious warning provided by the organization. The use of that label on hormone therapy is controversial, given that it was originally inspired by data that was later debunked.<\/p>\n Now, the FDA has initiated the process to remove the black box warning on all forms of hormone therapy. \u201cTragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,\u201d said FDA Commissioner Martin Makary, MD, in a statement<\/a>. \u201cFor too long, issues of women\u2019s health have been under-recognized. Women and their physicians should make decisions based on data, not fear.\u201d<\/p>\n But why did hormone therapy have a block box warning in the past, and why is this controversial now? Here\u2019s what you need to know.<\/p>\n Meet the experts<\/strong>: Mary Jane Minkin,<\/a> MD, is a clinical professor of obstetrics and gynecology and reproductive sciences at Yale School of Medicine and founder of Madame Ovary<\/a>. Lauren Streicher,<\/a> MD, is a clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and host of Dr. Streicher\u2019s Inside Information: Menopause, Midlife, and More podcast<\/a>.<\/p>\n What is hormone therapy?<\/strong><\/p>\n Hormone therapy (HT) is a treatment used for symptoms of menopause, according to the American College of Obstetricians and Gynecologists<\/a> (ACOG). It\u2019s also called \u201cmenopausal hormone therapy” (MHT), and, in the past, was commonly referred to as \u201chormone replacement therapy” (HRT).<\/p>\n There are two main types of hormone therapy: estrogen-only, and estrogen plus progestin, which helps to lower the risk of developing uterine cancer that can happen when a woman with an intact uterus only uses estrogen. (If you don’t have a uterus, say from a hysterectomy or other procedure, you don’t need the progestin\u2014which is the synthetic version of the hormone, progesterone\u2014as it protects the uterus from the effects of estrogen.) FYI: There is also some evidence that progestin may also help with hot flashes, per the ACOG.<\/p>\n Hormone therapy can be taken systemically, which means it\u2019s released into your blood stream, or locally, which is when vaginal rings, tablets, or creams release small doses of estrogen into the vaginal tissue, the ACOG explains.<\/p>\n Why did it have a black box warning?<\/strong><\/p>\n That\u2019s kind of a long story. Way back in 2002, the Women\u2019s Health Initiative published data<\/a> from a clinical trial that linked hormone therapy to a 29 percent increase in heart attacks, a 41 percent increase in strokes, and a higher risk of developing breast cancer. As a result, the trial was halted.<\/p>\n The FDA put a black box warning on estrogen products for hormone therapy in 2003, and it\u2019s stayed there ever since. And women largely stopped using hormone therapy as a result: In 2000, about one in five women<\/a> over 50 were taking hormone therapy, per the Menopause Society, but that number plummeted to less than five percent by 2008.<\/p>\n There\u2019s a big caveat here, though. Those original Women\u2019s Health Initiative findings have since been debunked. Researchers later found<\/a> that the original study looked at women who were 65 and older who already had a higher risk of the serious health complications just mentioned, and that skewed that data. (There were other issues, too.)<\/p>\n The original study authors even released a follow-up analysis in JAMA<\/a> in 2024 that stated that the benefits of hormone therapy outweigh the risks for most healthy women in menopause\u2014but that black box warning stuck around.<\/p>\n Why is this controversial?<\/strong><\/p>\n The two doctors Women’s Health spoke with agree that the black box warning should be removed from local estrogen therapy products. Patients and their partners will often get nervous when they see the label and think that it\u2019s \u201cnot worth it\u201d to use the medication, says Mary Jane Minkin,<\/a> MD, a clinical professor of obstetrics and gynecology and reproductive sciences at Yale School of Medicine and founder of Madame Ovary<\/a>.<\/p>\n Still, it\u2019s important that women talk to a trusted healthcare provider to get personalized medical advice when it comes to HT. Overall, “local vaginal estrogens are very safe products,” says Lauren Streicher,<\/a> MD, a clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and host of Dr. Streicher\u2019s Inside Information: Menopause, Midlife, and More podcast<\/a>.<\/p>\n However, while systemic therapy is also largely considered safe<\/a>, there can be nuances depending on the type of estrogen, the way it’s given, and a woman’s personal history, Dr. Streicher says, adding that some women still face some risks from hormone therapy, including those with a history of blood clots or breast cancer.<\/p>\n Because the FDA recommended removing the black box warning from all products, systemic ones included, there’s some controversy and ongoing conversations in the medical community on today’s announcement, with a number of doctors<\/a> (including WH advisor and cardiologist, Martha Gulati<\/a>, MD) emphasizing that further research is needed.<\/p>\n Whats more, typically, the FDA will have a scientific panel that meets and evaluates data in private, making an expert recommendation based on that, says Dr. Streicher. In this case, the event was a public roundtable discussion\u2014not a scientific panel. She also notes that the FDA commissioner doesn\u2019t usually decide on their own if a label should be changed or removed\u2014it\u2019s typically based on advice from a scientific advisory committee.<\/p>\n When will the labels be removed?<\/p>\n The FDA is requesting that companies make changes to the labels to remove references to risks of cardiovascular disease, breast cancer, and probable dementia, per the announcement.<\/p>\n How long that will actually take is not entirely clear, but the New York Times is reporting<\/a> that the changes are expected within six months.<\/p>\n You Might Also Like<\/strong><\/p>\n