FDA commissioner Dr. Marty Makary joins "CBS Mornings" to discuss the agency's announcement Thursday that boxed warnings will be removed from many estrogen products used for hormone therapy, a treatment that helps alleviate the symptoms of menopause.

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The U.S. Food and Drug Administration (FDA) has announced it will remove black box warnings from many hormone therapies used to treat menopause. These warnings, in place since 2003, cautioned about increased risks of breast cancer, stroke, and dementia, but new data reviewed by the FDA indicate that these treatments are safe and offer significant benefits.

FDA Commissioner Dr. Marty McCary stated that the decision is based on a more nuanced understanding of the risks and benefits of hormone therapy, with evidence showing improvements in quality of life and reductions in long-term health risks such as cognitive decline, heart attacks, and osteoporosis. The FDA hopes this change will make it easier for women to discuss hormone therapy options with their doctors.

Changes to "black box" warnings on hormone therapies for menopause

New this morning, some major health news that could help all the women out there who are going through that change of life. Starts with M. We're talking, of course, about menopause. CBS News Senior Correspondent, that's Nora O'Donnell, has more. Nora, good morning to you. This is exciting news you've got. Yeah, good morning to you, Gail. That's right, this is really big news, and everyone is going to hear it here first on your show. The FDA is announcing that it will remove warnings on many menopause hormone therapies. This is a move that could help tens of millions of women. These are these so-called black box warnings. It's the highest level of alert. They have been on treatments containing estrogen since 2003, cautioning about an increased risk of breast cancer, stroke, and possible dementia. Well, today, the FDA commissioner, Dr. Marty McCary, says the data not only indicates the treatment is safe, but that it also has many benefits. That's right. And so first on CBS Mornings, I spoke with the FDA commissioner and a leading menopause doctor about this new guidance. So good to see you. Dr. Rachel Rubin treats patients like Colleen Fisher, and full disclosure, me, women in perimenopause and menopause who are looking for relief. You feel like something's off, and you're not quite sure what it is. For me, I had experienced really severe night sweats and gone to my OBGYN, and she sort of was like, suck it up a little bit. There didn't seem to be- She was sort of like, this is this phase of life, and this is what it is, and so for about six or seven years, I felt like I was struggling. But Rubin, a board-certified urologist, says women don't need to struggle. How many millions of women are suffering unnecessarily? How many millions of women are in menopause? That number for American women is in the tens of millions, and each year, up to two million more enter menopause. But Rubin says there's a solution. If you've never heard of hormone therapy, how would you describe it? Hormone therapy is like your gas tank. It is the gas that helps you do all the things that you want to do. And so when those hormones come to an abrupt halt or a chaotic fluctuation in perimenopause and then a halt in menopause, you will feel the consequences. And when you- Every cell in your body. Every cell in your body will feel the consequences. And so the reality is, is we too often have dismissed those consequences to say, oh, it's normal aging. But the question is, can we safely do things that alleviate some of those consequences? And the science shows that you can safely provide hormone therapy? The science shows there are evidence-based ways to give back hormone therapy to really improve people's quality of life. In the late 1990s, more than one in four post-menopausal women were taking hormones to manage their hot flashes and mood swings. By 2020, that number dropped to one in 25. It's an American tragedy. I do think it's one of the biggest mistakes in modern medicine. That mistake, according to FDA Commissioner, Dr. Marty McCary, is the conclusion from a government study more than 20 years ago that suggested hormone therapy leads to an increased risk of breast cancer. There was no statistical significance and no subsequent clinical trial has ever shown an increase in breast cancer mortality. And look at the long-term health benefits, the reduction in cognitive decline, in heart attacks, in bone fractures, in other conditions, including cancer and diabetes that have been suggested in some studies. First on CBS News, McCary, a former cancer surgeon at the Johns Hopkins School of Medicine, explains the FDA's decision. So this is the black box warning. To remove the black box warning. We now have a more nuanced understanding and we want to put that fear machine in its proper context. In fact, you say hormone replacement therapy can be a breakthrough for women. Yeah, 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. Hmm. Boy, Nora, I could cry listening to this because this will be helpful to so many women, but it's maddening to me because I did not do hormone replacement therapy because of that warning. I would see that warning, it would scare me. And even when the doctor would say, no, we got to pay attention to this. And then years later, when people say it was safe, I still had that study in my mind. So I'm very excited for other women, but this is tough for me. What does the FDA now hope happens now that these warnings have been removed? Well, this is important, Gayle. I mean, the FDA commissioner said he hopes this will not just improve the quality of life for so many women, but also save lives. Dr. McCary said it not only alleviates those short-term symptoms, Gayle, that you were talking about, hot flashes, night sweats, and weight gain, but there are also these long-term health benefits. Preventing cardiovascular disease, preventing osteoporosis, that's a leading cause of death and disability in old women, and it helps prevent cognitive decline, including Alzheimer's. Dr. McCary even told us that he wishes his own mother could have had this treatment. Now, obviously, you should talk to your doctor to see if hormone therapy is right for you, but bottom line, the FDA hopes that taking these labels off many of these treatments will make that conversation easier with doctors. Gayle. Yeah, it's gonna help a lot of people. Nora, thank you so much.

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