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Health and Human Services Secretary Robert F. Kennedy Jr. announced Monday that the U.S. Food and Drug Administration would remove “broad black box” warnings from hormone replacement therapy products for menopause. More than 20 estrogen-related products used to treat hot flashes and other symptoms for decades will no longer carry a warning label about cardiovascular disease, breast cancer and probable dementia. The warning will not be removed for the risk of endometrial cancer for systemic estrogen-alone products. “Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” Kennedy said in a statement. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” he added. “We are returning to evidence-based medicine and giving women control over their health again.” Monday’s announcement comes following an expert literature review conducted in July, that included doctors and researchers who supported the health benefits of the drugs. The FDA is now working with drugmakers to update and reprint labels. The agency also said it had approved two new drugs to expand treatment options for menopausal symptoms, including a generic version of Premarin and a non-hormonal medication to treat hot flashes and other symptoms related to blood vessels widening and constricting. As women experience menopause in their forties and fifties, their ovaries produce less of the sex- and reproductive-regulating hormones estrogen and progesterone. Hormone replacement therapy products can restore declining hormones and relieve uncomfortable symtpoms, including night sweats and bone loss. Following a landmark study linking hormone pills to higher rates of cancer, stroke and blood clots in 2002, prescriptions for the medications fell. Since then, all estrogen drugs have carried the FDA’s boxed warning. However, additional research has revealed a more nuanced outlook on associated risks, and a new analysis of the 2002 data found that women in their fifties who took estrogen-based drugs faced no increased risk of heart problems, whereas women in their seventies did. Kennedy and FDA Commissioner Marty Makary said that the labels had scared women off from the treatment. “Tragically, 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,” said Makary. The American College of Obstetricians & Gynecologists applauded the action, saying modifications to certain warning labels for estrogen products are “years in the making.” “The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms,” Dr. Steven J. Fleischman, president of the American College of Obstetricians & Gynecologists, said in a statement reacting to the news. And, Fleischman noted that systemic estrogen products are not without risk. “While we support that this change will put shared decision-making back in the hands of patients and their trusted clinicians, it is important to distinguish that systemic estrogen products — such as oral estrogen and transdermal patches, gels, and sprays — have a different safety profile than low-dose vaginal estrogen,” he said. With reporting from The Associated Press
